Podcasts about emergency use authorization eua

Wondering how Pfizer and partner BioNTech developed a COVID-19 vaccine in record time without compromising safety? Dr Bill Gruber, SVP of Pfizer Vaccine Clinical Research and Development, explains the process from start to finish. “I told my team, at first we were inspired by hope and now we're inspired by reality,” Dr Gruber said. “If you bring critical science together, talented team members together, government, academia, industry, public health officials—you can achieve what was previously the unachievable.” The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent COVID-19 for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the emergency declaration unless ended sooner. See Fact Sheet: cvdvaccine-us.com/recipients. --------------------------------------------------------------------------------- BILL GRUBER: Dr. Bill Gruber is senior vice president of Pfizer Vaccine Clinical Research and Development, and is responsible for global clinical development of vaccines. Dr. Gruber was previously an associate professor of pediatrics at Vanderbilt University School of Medicine and also served as the director of the Diagnostic Virology Laboratory at Vanderbilt University Hospital. Dr. Gruber received his bachelor degree in mathematical sciences from Rice University, Houston, Texas, and his medical degree from Baylor College of Medicine, Houston, Texas. He is board-certified in pediatrics and pediatric infectious diseases and has authored or co-authored 140 original research articles and numerous invited articles and book chapters. ---------------------------------------------------------------------------------- TRANSCRIPT: DR. BILL GRUBER: Historically, vaccines have been one of the most important medical intervention for public health. Diseases like smallpox that used to have a 30% mortality rate, that are completely wiped from the face of the Earth. When it looked like there was the potential for us to engage in moving forward a COVID-19 vaccine, there was the daunting challenge to do something that had never been done before. And that was to try to get a vaccine out within less than a year. That, I can tell you, is unprecedented in history. My name is Bill Gruber. I head vaccine clinical research and development for Pfizer and I've been involved in vaccine development for over 35 years. If you had asked me at the time, “what did I think the chances of our success were at the very beginning of this?” I would say well less than 50% becau..... Learn more about your ad choices. Visit megaphone.fm/adchoices

Breaking News, 101 Days To Vote For The Government You Want, Day 294 Of The Israel Hamas War, Brace yourself, America. With Kamala Harris, Democrats Are About To Put On An Incredible Show, And Is Unity Possible in US Politics? 2 Very Independent and Compelling Hours of Experts, And Authors Pursuing The Truth No Matter Where It Leads 9:06-9:29a ET- Liz Peek- Brace yourself, America. With Kamala Harris, Democrats are about to put on an incredible show. The tidal wave of money and faux enthusiasm is already flowing into the campaign to convince us of four more years of Biden policies if not worse is good for America. The Fox News Contributor and Wall Street Analyst reports. 9:32-9:58a ET- Paul Begley- Is Unity Possible in US Politics? According to a pastor and author of “Revelation 911: How the Book of Revelation Intersects with Today's Headlines, to cultivate a genuinely unified society, we must first recognize the impossibility of an alliance between good and evil. Those of a conservative or Christian worldview cannot compromise moral and cultural values in the pursuit of unity. 10:06-10:29a ET- Jon Fleetwood- Jon of JonFleetwood.com lays out new evidence pointing to an imminent bird flu pandemic. Will they use an Emergency Use Authorization (EUA) for a bird flu vaccine just like they did with the COVID-19 jab? 10:32-10:58a ET- Curtis Hill- Secret Services Incompetence is no longer hidden. From their failure in the participation of an attempted assassination to the resignation of the Secret Service director, it's becoming painfully obvious that there must be a total overhaul of this once proud institution. Discussing this provocative topic is the Indiana former attorney general from 2017-2021 and now ambassador with the Project 21 black leadership network.

Evusheld is the FDA approved, lab created, preventative monoclonal antibody therapy. In addition to the lab-created variety of monoclonal antibodies (Evusheld), there are biologically derived monoclonal antibodies which are spun from the blood from people who are sick with COVID and administered to those who are sick with COVID to help speed their recovery. Evusheld is a protein that is designed to look like the proteins we make when we get sick. When injected, it makes a body like mine think we've already been sick which then keeps us from getting COVID. When I received it there were four vials injected as 2 shots in the buttocks every six months. I was a candidate for Evusheld because I'm so immune suppressed because of the chemotherapy I'm taking. Evusheld had Emergency Use Authorization (EUA) from the FDA. However, at the end of January, that EUA was revoked. Evusheld has been proved ineffective against the current COVID variants. Therefore, for the severely immunosuppressed, there is no longer a preventative option for avoiding COVID. The alternatives are now post-viral options Paxlovid and Molnupiravir, and monoclonal antibody treatment in the hospital or in urgent care clinics. Perhaps as this virus evolves and becomes less deadly we'll continue to see the threat decrease. Have you taken Evusheld? What factors in to your thinking about COVID these days? I'm Annette Leonard, speaker, coach, and sick person who believes that my illnesses do not define me. If health is the absence of disease and wellness is the presence of wholeness, then no matter what your disease status, we can work toward your wellness, your wholeness. Whether or not you are ever "healthy" on paper, you can be well. Join me and others on the path back to wholeness at AnnetteLeonard.com. Whether you are a person experiencing chronic illness or are someone who loves or serves people with chronic illness I have great resources here on this channel or on my website for you.

Questions continue to be raised regarding COVID-19 vaccines and whether their manufacturers, and even the government, have been honest with the American public. It's now a regular occurrence to hear about those in their teens and 20's dying from myocarditis or going into cardiac arrest. Others are questioning the use of mRNA vaccines, even as the Florida surgeon general has issued a health alert on their safety. There's also great concern that the CDC is adding COVID shots to the recommended vaccine schedule for children and adults.--To sort things out regarding this issue, Crosstalk welcomed back Barbara Loe Fisher. Barbara is the president of the National Vaccine Information Center -NVIC-, a non-profit charity she co-founded with parents of DPT vaccine injured children in 1982.--Jim indicated that the first COVID-19 shot was given on December 14th of 2020. The narrative given then continues on. We're told that all is well and that the vaccines are safe. President Biden told America that if you get the shot, you can't get COVID. We know now that isn't the case. --So what have we learned since that first shot was given-- As you may recall, the mRNA vaccines from Pfizer and Moderna were rolled out in 2020 under what's called an Emergency Use Authorization -EUA-. According to Barbara, they haven't been officially licensed for young children so these vaccines are still under an EUA for them. --When the vaccines began to be used, the Vaccine Adverse Event Reporting System -VAERS- began to show that these vaccines were very reactive and now we know that it is the most reactive vaccine ever put on the market.

Questions continue to be raised regarding COVID-19 vaccines and whether their manufacturers, and even the government, have been honest with the American public. It's now a regular occurrence to hear about those in their teens and 20's dying from myocarditis or going into cardiac arrest. Others are questioning the use of mRNA vaccines, even as the Florida surgeon general has issued a health alert on their safety. There's also great concern that the CDC is adding COVID shots to the recommended vaccine schedule for children and adults.--To sort things out regarding this issue, Crosstalk welcomed back Barbara Loe Fisher. Barbara is the president of the National Vaccine Information Center -NVIC-, a non-profit charity she co-founded with parents of DPT vaccine injured children in 1982.--Jim indicated that the first COVID-19 shot was given on December 14th of 2020. The narrative given then continues on. We're told that all is well and that the vaccines are safe. President Biden told America that if you get the shot, you can't get COVID. We know now that isn't the case. --So what have we learned since that first shot was given-- As you may recall, the mRNA vaccines from Pfizer and Moderna were rolled out in 2020 under what's called an Emergency Use Authorization -EUA-. According to Barbara, they haven't been officially licensed for young children so these vaccines are still under an EUA for them. --When the vaccines began to be used, the Vaccine Adverse Event Reporting System -VAERS- began to show that these vaccines were very reactive and now we know that it is the most reactive vaccine ever put on the market.

Glen Macko joins April Moss to discuss the latest findings from former Pharma Executive Sasha Latypova, along with researcher Karen Watt obtained documents via FOIA requests and active laws that show the following:According to congressionally passed statutes, research of active laws, and extra details obtained through the Freedom of Information Act, the Department of Defense owns, implements, and oversees the COVID-19 vaccine program as a "Countermeasure" to foreign attack. While the public was bombarded with an orchestrated fear campaign, the U.S. Government managed the Covid response as a national security threat.  The Four-Legged StoolThe undercover operation was orchestrated utilizing four critical legal maneuvers: 1. Public Health Emergency (PHE), 2. Emergency Use Authorization (EUA),3. Public Readiness and Emergency Preparedness (PREP Act), 4. Other Transactions Authority (OTA)On January 31, 2020, Health and Human Services (HHS) Secretary, Alex M. Azar declared a Public Health Emergency (PHE) pursuant to section 319 of the Public Health Services (PHS) Act, 42 U.S.C. 247d, for the entire United States. A PHE bestows a substantial amount of war-time authority upon the HHS Secretary. This PHE declaration was one day after a similar declaration by the WHO.On March 10, 2020, HHS Secretary, Alex M. Azar, issued a “Notice of Declaration” to activate the PREP Act to provide liability immunity for Covered Persons and Covered Countermeasures. The PREP Act declaration filled six pages of the Federal Register on March 17, 2020 that can be found here, https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdfThe American people were led to believe that the FDA, CDC, and figureheads like Anthony Fauci oversaw the COVID-19 vaccine program. Their involvement was an orchestrated information operation. All decisions concerning the COVID-19 vaccine research, materials acquisition, distribution, and information sharing were tightly controlled by the DoD.  Hundreds of Covid countermeasures contracts have been uncovered. Many disclosures are in redacted form. However, Latypova and Watt have found sources to fill in the details. A review of these contracts indicates a high degree of control by the U.S. Government (DoD/BARDA). It specifies the scope of deliverables as "demonstrations" and "prototypes" only while excluding clinical trials and manufacturing quality control from the scope of work paid for by the contracts. To ensure that the Pharma is free to conduct the fake clinical trials without financial risk, the contracts include the removal of all liability for the manufacturers and any contractors along the supply and distribution chain under the 2005 PREP Act and related federal legislation. Support the show

EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today's discussion with guest, Mike Drues.Mike Drues is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn what Mike has to say about what EUAs are, what COVID has taught the market about EUAs, and what path FDA reviews are on now. Some of the highlights of this episode include:What an EUA is, and when it's usedAn EUA as a pathway to marketWhat the COVID experience has taught us about EUAWhether FDA reviews are back to normalThe poor quality of some EUA submissionsQuality requirements for EUA vs. non-EUA devicesWhat's new in EUAs beyond COVIDMonkeypox EUA developmentsImprovements in EUA qualities as submissions continueTop takeaways from today's discussionMemorable quotes from Mike Drues:“One of the things I've learned in playing this game now for about 30 years is most problems that companies get into, not only are they preventable, they're predictable.”“As a matter of fact, FDA estimates that 80% of submissions, 80% of EUA submissions, needed revisions, needed additional information.” “If you have experience doing these things, you're going to be more successful. If you don't have experience doing these things, that's not a problem; you can't be an expert at everything, but get somebody to help you.” “Don't treat FDA as our elementary school teacher.” Links:Mike Drues LinkedInArticle: FDA wants COVID test developers to shift from EUAs to traditional premarket pathways (RAPS, Sept 27, 2022)Article: FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing (HHS, Office of Inspector General, Sept 2022) ReportCDRH Website: Monkeypox Emergency Use Authorizations for Medical DevicesArticle: FDA issues draft guidance for transitioning medical devices granted EUAs during pandemicFDA Guidance: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyFDA Guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyWebinar: How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The Covid-19 Pandemic? Mike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 1 hereMike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 2 hereEmergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know (GreenLight.Guru, April, 2020)Podcast: Tips For Being Prepared Post-EUA (January, 2022)Greenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

EP. 122 - As COVID-19 continues to evolve, it is essential to consider vaccine options that provide a broad immune response against a range of variants. The Novavax COVID-19 Vaccine uses protein-based technology similar to technologies used in vaccines to protect against Hepatitis B, Flu and Whooping Cough. Now available in all 50 states, the two-dose primary series has received Emergency Use Authorization (EUA) for ages 12+ and is also currently under review by the FDA for use as a booster. Novavax Executive Vice President & Chief Communications Officer Silvia Taylor joined me to share more information. Please subscribe and rate our show!

Todos Medical Ltd. (OTCQB:TOMDF) CEO Gerald Commissiong tells Proactive's Stephen Gunnion that the company is still looking to offer saliva-based PCR testing for monkeypox. That's after the company's clinical laboratory Provista Diagnostics Inc filed an Emergency Use Authorization (EUA) application with the US Food & Drug Administration (FDA) for its lesion-based PCR monkeypox test. Commissiong says the company will continue to conduct additional research and gather data until the FDA opens the pathway for saliva-based testing to detect monkeypox before symptoms start to appear. #ProactiveInvestors #TodosMedical #ProvistaDiagnostics #monkeypox #OTCQB

As a person valuing our planet, I have not turned my heat on since the 73 oil embargo except for guests (even in the snow and ice) and refused to use my air conditioning in the tropics although the US Embassy paid my utility bills. However, this question needs to be asked and is answered by today's guest. Some have said that the government can cause a problem and then come up with the solution. According to the documentary Something Ain't Right, narrated by Kevin Sorbo, had the governments not censored doctors who were successfully treating covid at the early stages, 80 % of covid deaths could have been avoided. Had these doctors not been censored, it is likely that there would have been no lockdowns or mandates as the Emergency Use Authorization (EUA still in effect in the US?) could not have been evoked. An EUA can only be evoked if there are no available alternative treatments. So is the premise of this broadcast conspiracy or reality?

As a person valuing our planet, I have not turned my heat on since the 73 oil embargo except for guests (even in the snow and ice) and refused to use my air conditioning in the tropics although the US Embassy paid my utility bills. However, this question needs to be asked and is answered by today's guest. Some have said that the government can cause a problem and then come up with the solution. According to the documentary Something Ain't Right, narrated by Kevin Sorbo, had the governments not censored doctors who were successfully treating covid at the early stages, 80 % of covid deaths could have been avoided. Had these doctors not been censored, it is likely that there would have been no lockdowns or mandates as the Emergency Use Authorization (EUA still in effect in the US?) could not have been evoked. An EUA can only be evoked if there are no available alternative treatments. So is the premise of this broadcast conspiracy or reality?

As a person valuing our planet, I have not turned my heat on since the 73 oil embargo except for guests (even in the snow and ice) and refused to use my air conditioning in the tropics although the US Embassy paid my utility bills. However, this question needs to be asked and is answered by today's guest. Some have said that the government can cause a problem and then come up with the solution. According to the documentary Something Ain't Right, narrated by Kevin Sorbo, had the governments not censored doctors who were successfully treating covid at the early stages, 80 % of covid deaths could have been avoided. Had these doctors not been censored, it is likely that there would have been no lockdowns or mandates as the Emergency Use Authorization (EUA still in effect in the US?) could not have been evoked. An EUA can only be evoked if there are no available alternative treatments. So is the premise of this broadcast conspiracy or reality?

This is Garrison Hardie with your CrossPolitic Daily News Brief for Wednesday, October 12th, 2022. I just got back from our Fight Laugh Feast Conference in Knoxville TN, and we announced while we were out there, where our next conference will be at the Ark Encounter next year! So stay tuned for when registration will open up, and we hope to see you and your family out in Kentucky, October of next year. Also, FLF Magazine: We are on a mission to make magazines great again. So, subscribe to our Fight Laugh Feast magazine. This is a quarterly mini-book like experience, packed full of a variety of authors that includes theologically-driven cultural commentary, a Psalm of the quarter, recipes for feasting, laughter sprinkled throughout the glossy pages, and more. Sign your church up, sign your grumpy uncle up, and while you are at it…sign up the Pope, Elon Musks, and Russel Moore. Disclaimer: This magazine will guarantee various responses and CrossPolitic is not held liable for any of them. Reading the whole magazine may cause theological maturation, possibly encourage your kids to take the Lord’s Supper with you, and will likely cause you to randomly chuckle in joy at God’s wondrous world. Sign up today! Four issues and $60 per year, that is it. Go to fightlaughfeast.com right now to sign up!. Now, here’s what you may have missed over the weekend. https://www.dailywire.com/news/colorado-officials-incorrectly-sent-out-30000-voter-registration-postcards-to-noncitizens Colorado Officials ‘Incorrectly’ Sent Out 30,000 Voter Registration Postcards To Noncitizens Colorado officials claim they accidentally sent approximately 30,000 postcards last month to noncitizens instructing them how they could register to vote. First reported by Colorado Public Radio News, Democratic Secretary of State Jena Griswold’s office said department employees had sent the postcards on Sept. 27 after comparing a list of 102,000 names provided by the Electronic Registration Information Center, a nonprofit organization aiming to improve U.S. voter rolls and advocating residents to vote. “The Department has become aware that approximately 30,000 EBU [Eligible But Unregistered] postcard mailers were incorrectly sent to ineligible Coloradans,” a spokesperson for the Colorado Secretary of State’s Office told local media. “The office is undertaking an internal review of the incident and will take any corrective action that is warranted.” Griswold insisted noncitizens would not be allowed to register to vote. The postcards, which the office printed in English and Spanish, read, “A message from Colorado Secretary of State Jena Griswold . . . Our records indicate that you or your household may be eligible to vote, but do not appear to be registered at your current address.” The mailers did include that to vote that residents must be 18 years old by Election Day, a United States citizen, and a Colorado resident for at least 22 days before the upcoming election, according to Colorado Public Radio News. Griswold’s office said they plan on sending out correction mailers to the noncitizens, “reminding them that only those that meet the above requirements are eligible to register.” According to local media, while the office had compared the list of potential unregistered voters to local DMV records, the data had included noncitizen drivers with Colorado driver’s licenses which the state issues for noncitizens to drive legally. The National Council on State Legislatures website shows Colorado as one of at least 17 states, along with the District of Columbia, that issue driver’s licenses to non-U.S. citizens. However, the system did not distinguish their eligibility to vote. Sean Morales-Doyle, director of the Voting Rights Program at the Brennan Center for Justice, told The Journal that the system making a mistake indicates it works. Griswold is up for reelection in the November midterms, where she will face Republican Pam Anderson, the head of the state’s county clerks association. https://www.theepochtimes.com/exclusive-cdc-wont-release-review-of-post-vaccination-heart-inflammation_4786038.html?utm_source=partner&utm_campaign=BonginoReport&src_src=partner&src_cmp=BonginoReport CDC Won’t Release Review of Post-Vaccination Heart Inflammation The U.S. Centers for Disease Control and Prevention (CDC) will not release its review of post-COVID-19-vaccination heart inflammation. The CDC has been performing abstractions on reports of post-vaccination myocarditis, a form of heart inflammation, submitted to the Vaccine Adverse Event Reporting System. But the agency is saying that federal law prevents it from releasing the results. The abstractions “are considered medical records which are withheld in full from disclosure,” the CDC told The Epoch Times in a recent letter, responding to a Freedom of Information Act request. One of the exemptions in the act says that agencies can withhold materials that are “specifically exempted from disclosure by statute, if that statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld; and (B) if enacted after the date of enactment of the OPEN FOIA Act of 2009, specifically cites to this paragraph.” The CDC pointed to the Public Health Service Act, which was enacted in 1944, and says that vaccine injury reports and other information that may identify a person shall not be made available to any person except the person who received the vaccine or a legal representative for that person. The information sought is available through the CDC website without details that would identify patients, the agency also said. The CDC said that it does not have a formal definition of “abstraction” but that it means the process of reviewing medical records, including autopsy reports and death certificates, and recording data in a database. “Please note that this definition means that any abstracted data, because they originate from medical records, is also considered medical records,” a CDC records officer told The Epoch Times in an email. Refusing to release the data raises concerns about transparency, according to Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center. “The stubborn refusal of officials heading up federal health agencies responsible for protecting the public health to come clean with Americans about what they know about COVID vaccine risks is stunning,” Fisher told The Epoch Times in an email. Fisher noted that the CDC has funded electronic medical record systems that collect personal health information and that the agency shares the data with a number of third parties, such as contractors and researchers. Fisher called for a congressional probe into what she described as “the disturbing lack of transparency on the part of federal agency officials, who granted COVID vaccine manufacturers an Emergency Use Authorization (EUA) to widely distribute the vaccines in December 2020 and have recommended and aggressively promoted the vaccines for mandated use ever since.” In response to a separate Freedom of Information Act request, the CDC initially said that it did not perform any abstractions or produce any reports on post-vaccination myocarditis. That request was for reports between April 2, 2021, and Oct. 2, 2021. The agency also falsely said that a link between myocarditis and the messenger RNA COVID-19 vaccines was not known during that time. A possible link between those vaccines, made by Pfizer and Moderna, became known in early 2021. Many experts now acknowledge the link is likely or definitely causal. Dr. Rochelle Walensky, the CDC’s director, said in a press conference in April 2021 that the agency had not detected a link between the vaccines and myocarditis. The basis for that statement remains unclear. The CDC still hasn’t released the results of the data mining, to The Epoch Times, Sen. Ron Johnson (R-Wis.), or a nonprofit called Children’s Health Defense. The agency also declined to provide results from a different monitoring system, V-safe, to a nonprofit called Informed Consent Action Network, which then sued the agency and just recently received the first tranche of data. The FDA, meanwhile, has refused to release the results of a different type of analysis on the VAERS data, claiming it cannot separate the results from protected internal communications. The agency is also withholding autopsies conducted on people who died after getting COVID-19 vaccines, pointing to exceptions laid out in the Freedom of Information Act. Along with Johnson, several other lawmakers are pressing at least one of the agencies to release the data, asserting that not doing so is illegal. https://www.breitbart.com/politics/2022/10/10/nike-co-founder-phil-knight-donates-1-million-to-republican-oregon-gov-candidate-christine-drazan/ Nike Co-Founder Phil Knight Donates $1 Million to Republican Oregon Gov. Candidate Christine Drazan Knight’s donation to Drazan’s campaign comes after he donated $3.75 million to Independent candidate Betsy Johnson, signaling his strong dislike for Tina Kotek. Republican strategist Rebecca Tweed told KGW Knight’s donation said the two donations are not meant as an endorsement of either candidate but rather an attack against the Democrat candidate. The donation comes as Christine Drazan stands within striking distance of unseating Kotek in a deep blue state that has not elected a Republican governor since Vic Atiyeh in 1982. As Breitbart News reported last week, a recent Emerson College poll showed the Oregon House Republican leader actually leading Koteck by two points – 36 percent to 34 percent. A new Emerson College Polling survey shows former Oregon House Republican leader Drazan ahead of former state House Speaker Tina Kotek (D)–36 percent to 34 percent. Nineteen percent of those polled plan to vote for former Democrat state senator-turned independent Betsy Johnson. The poll was conducted between Sept. 30 – Oct. 1 with 796 very likely Oregon voters. The survey’s Credibility Interval (CI), similar to a margin of error, is ±3.4 percentage points. KGW political analyst Len Bergstein concurred with Rebecca Tweed that Phil Knight’s donation should be seen as a knock against Kotek by potentially putting Drazan on the path to victory. “As soon as he sees some polls that say ‘wait a minute, there’s a chance that Drazan could win,’ he’s saying well maybe my money could make the difference to push her over the top,” said Bergstein. “This is not a normal election. We’re having fun watching it because we have three original candidates for governor and a lot of interesting twists and turns in the race already,” Bergstein added. Armored Republic The Mission of Armored Republic is to Honor Christ by equipping Free Men with Tools of Liberty necessary to preserve God-given rights. In the Armored Republic there is no King but Christ. We are Free Craftsmen. Body Armor is a Tool of Liberty. We create Tools of Liberty. Free men must remain ever vigilant against tyranny wherever it appears. God has given us the tools of liberty needed to defend the rights He bestowed to us. Armored Republic is honored to offer you those Tools. Visit them, at ar500armor.com https://thepostmillennial.com/bidens-railway-deal-to-avert-strike-spiked-by-union?utm_campaign=64487 Biden's railway deal to avert strike spiked by union Nearly a month after President Biden announced that a deal had been reached between railroad companies and their unions, the deal has fallen apart, raising concerns for a possible strike. The Brotherhood of Maintenance of Way Employees Division of the Teamsters, one of the nation’s largest railroad unions, rejected the deal on Monday, expressing discontent with the number of paid sick days, according to the Washington Post. Officials said that members of the third-largest union rejected the proposed five-year contract in a 56 to 43 percent split. Both sides have agreed to continue with negotiations until at least November 19. Railroads are currently expected to continue operating normally. The deal included a 24 percent increase in pay by 2024, as well as $1,000 annual bonuses for employees over five years. The plan ensured that healthcare co-pays would not increase in price, but included only one paid sick day compared to the 15 days union leaders pushed for. The deal followed two years of negotiations between the rail carriers and unions, which prompted the White House to appoint an emergency board in July to mediate between the two groups. In September, Biden applauded the tentative deal reached, calling it "an important win for our economy and the American people." Now, it’s time for my favorite topic, sports! Let’s catch up with what’s happening in the world of football shall we? First in the college ranks: #3 Alabama 24 Texas A&M 20 #2 Ohio State 49 Michigan State 20 #1 Georgia 42 Auburn 10 #15 NC State 19 Florida State 17 Texas 49 OU 0 #13 TCU 38 #19 Kansas 31 #7 USC 30 WSU 14 NFL: Giants 27 Packers 22 Chargers 30 Browns 28 Jets 40 Dolphins 17 Bills 38 Steelers 3 Cowboys 22 Rams 10 Chiefs 30 Raiders 29 So that’s what you may have missed over the weekend: This has been your CrossPolitic Daily News Brief. If you liked the show, hit that share button for me down below. If you want to come to our conference next year, if you want to sign up for a club membership, or sign up for a magazine subscription, you can do all of that at fightlaughfeast.com. As always, if you’d like to email me a news story, ask about our conference, or become a corporate partner of CrossPolitic, email me, at garrison@fightlaughfeast.com. For CrossPolitic News, I’m Garrison Hardie. Have a great day, and Lord bless.

This is Garrison Hardie with your CrossPolitic Daily News Brief for Wednesday, October 12th, 2022. I just got back from our Fight Laugh Feast Conference in Knoxville TN, and we announced while we were out there, where our next conference will be at the Ark Encounter next year! So stay tuned for when registration will open up, and we hope to see you and your family out in Kentucky, October of next year. Also, FLF Magazine: We are on a mission to make magazines great again. So, subscribe to our Fight Laugh Feast magazine. This is a quarterly mini-book like experience, packed full of a variety of authors that includes theologically-driven cultural commentary, a Psalm of the quarter, recipes for feasting, laughter sprinkled throughout the glossy pages, and more. Sign your church up, sign your grumpy uncle up, and while you are at it…sign up the Pope, Elon Musks, and Russel Moore. Disclaimer: This magazine will guarantee various responses and CrossPolitic is not held liable for any of them. Reading the whole magazine may cause theological maturation, possibly encourage your kids to take the Lord’s Supper with you, and will likely cause you to randomly chuckle in joy at God’s wondrous world. Sign up today! Four issues and $60 per year, that is it. Go to fightlaughfeast.com right now to sign up!. Now, here’s what you may have missed over the weekend. https://www.dailywire.com/news/colorado-officials-incorrectly-sent-out-30000-voter-registration-postcards-to-noncitizens Colorado Officials ‘Incorrectly’ Sent Out 30,000 Voter Registration Postcards To Noncitizens Colorado officials claim they accidentally sent approximately 30,000 postcards last month to noncitizens instructing them how they could register to vote. First reported by Colorado Public Radio News, Democratic Secretary of State Jena Griswold’s office said department employees had sent the postcards on Sept. 27 after comparing a list of 102,000 names provided by the Electronic Registration Information Center, a nonprofit organization aiming to improve U.S. voter rolls and advocating residents to vote. “The Department has become aware that approximately 30,000 EBU [Eligible But Unregistered] postcard mailers were incorrectly sent to ineligible Coloradans,” a spokesperson for the Colorado Secretary of State’s Office told local media. “The office is undertaking an internal review of the incident and will take any corrective action that is warranted.” Griswold insisted noncitizens would not be allowed to register to vote. The postcards, which the office printed in English and Spanish, read, “A message from Colorado Secretary of State Jena Griswold . . . Our records indicate that you or your household may be eligible to vote, but do not appear to be registered at your current address.” The mailers did include that to vote that residents must be 18 years old by Election Day, a United States citizen, and a Colorado resident for at least 22 days before the upcoming election, according to Colorado Public Radio News. Griswold’s office said they plan on sending out correction mailers to the noncitizens, “reminding them that only those that meet the above requirements are eligible to register.” According to local media, while the office had compared the list of potential unregistered voters to local DMV records, the data had included noncitizen drivers with Colorado driver’s licenses which the state issues for noncitizens to drive legally. The National Council on State Legislatures website shows Colorado as one of at least 17 states, along with the District of Columbia, that issue driver’s licenses to non-U.S. citizens. However, the system did not distinguish their eligibility to vote. Sean Morales-Doyle, director of the Voting Rights Program at the Brennan Center for Justice, told The Journal that the system making a mistake indicates it works. Griswold is up for reelection in the November midterms, where she will face Republican Pam Anderson, the head of the state’s county clerks association. https://www.theepochtimes.com/exclusive-cdc-wont-release-review-of-post-vaccination-heart-inflammation_4786038.html?utm_source=partner&utm_campaign=BonginoReport&src_src=partner&src_cmp=BonginoReport CDC Won’t Release Review of Post-Vaccination Heart Inflammation The U.S. Centers for Disease Control and Prevention (CDC) will not release its review of post-COVID-19-vaccination heart inflammation. The CDC has been performing abstractions on reports of post-vaccination myocarditis, a form of heart inflammation, submitted to the Vaccine Adverse Event Reporting System. But the agency is saying that federal law prevents it from releasing the results. The abstractions “are considered medical records which are withheld in full from disclosure,” the CDC told The Epoch Times in a recent letter, responding to a Freedom of Information Act request. One of the exemptions in the act says that agencies can withhold materials that are “specifically exempted from disclosure by statute, if that statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld; and (B) if enacted after the date of enactment of the OPEN FOIA Act of 2009, specifically cites to this paragraph.” The CDC pointed to the Public Health Service Act, which was enacted in 1944, and says that vaccine injury reports and other information that may identify a person shall not be made available to any person except the person who received the vaccine or a legal representative for that person. The information sought is available through the CDC website without details that would identify patients, the agency also said. The CDC said that it does not have a formal definition of “abstraction” but that it means the process of reviewing medical records, including autopsy reports and death certificates, and recording data in a database. “Please note that this definition means that any abstracted data, because they originate from medical records, is also considered medical records,” a CDC records officer told The Epoch Times in an email. Refusing to release the data raises concerns about transparency, according to Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center. “The stubborn refusal of officials heading up federal health agencies responsible for protecting the public health to come clean with Americans about what they know about COVID vaccine risks is stunning,” Fisher told The Epoch Times in an email. Fisher noted that the CDC has funded electronic medical record systems that collect personal health information and that the agency shares the data with a number of third parties, such as contractors and researchers. Fisher called for a congressional probe into what she described as “the disturbing lack of transparency on the part of federal agency officials, who granted COVID vaccine manufacturers an Emergency Use Authorization (EUA) to widely distribute the vaccines in December 2020 and have recommended and aggressively promoted the vaccines for mandated use ever since.” In response to a separate Freedom of Information Act request, the CDC initially said that it did not perform any abstractions or produce any reports on post-vaccination myocarditis. That request was for reports between April 2, 2021, and Oct. 2, 2021. The agency also falsely said that a link between myocarditis and the messenger RNA COVID-19 vaccines was not known during that time. A possible link between those vaccines, made by Pfizer and Moderna, became known in early 2021. Many experts now acknowledge the link is likely or definitely causal. Dr. Rochelle Walensky, the CDC’s director, said in a press conference in April 2021 that the agency had not detected a link between the vaccines and myocarditis. The basis for that statement remains unclear. The CDC still hasn’t released the results of the data mining, to The Epoch Times, Sen. Ron Johnson (R-Wis.), or a nonprofit called Children’s Health Defense. The agency also declined to provide results from a different monitoring system, V-safe, to a nonprofit called Informed Consent Action Network, which then sued the agency and just recently received the first tranche of data. The FDA, meanwhile, has refused to release the results of a different type of analysis on the VAERS data, claiming it cannot separate the results from protected internal communications. The agency is also withholding autopsies conducted on people who died after getting COVID-19 vaccines, pointing to exceptions laid out in the Freedom of Information Act. Along with Johnson, several other lawmakers are pressing at least one of the agencies to release the data, asserting that not doing so is illegal. https://www.breitbart.com/politics/2022/10/10/nike-co-founder-phil-knight-donates-1-million-to-republican-oregon-gov-candidate-christine-drazan/ Nike Co-Founder Phil Knight Donates $1 Million to Republican Oregon Gov. Candidate Christine Drazan Knight’s donation to Drazan’s campaign comes after he donated $3.75 million to Independent candidate Betsy Johnson, signaling his strong dislike for Tina Kotek. Republican strategist Rebecca Tweed told KGW Knight’s donation said the two donations are not meant as an endorsement of either candidate but rather an attack against the Democrat candidate. The donation comes as Christine Drazan stands within striking distance of unseating Kotek in a deep blue state that has not elected a Republican governor since Vic Atiyeh in 1982. As Breitbart News reported last week, a recent Emerson College poll showed the Oregon House Republican leader actually leading Koteck by two points – 36 percent to 34 percent. A new Emerson College Polling survey shows former Oregon House Republican leader Drazan ahead of former state House Speaker Tina Kotek (D)–36 percent to 34 percent. Nineteen percent of those polled plan to vote for former Democrat state senator-turned independent Betsy Johnson. The poll was conducted between Sept. 30 – Oct. 1 with 796 very likely Oregon voters. The survey’s Credibility Interval (CI), similar to a margin of error, is ±3.4 percentage points. KGW political analyst Len Bergstein concurred with Rebecca Tweed that Phil Knight’s donation should be seen as a knock against Kotek by potentially putting Drazan on the path to victory. “As soon as he sees some polls that say ‘wait a minute, there’s a chance that Drazan could win,’ he’s saying well maybe my money could make the difference to push her over the top,” said Bergstein. “This is not a normal election. We’re having fun watching it because we have three original candidates for governor and a lot of interesting twists and turns in the race already,” Bergstein added. Armored Republic The Mission of Armored Republic is to Honor Christ by equipping Free Men with Tools of Liberty necessary to preserve God-given rights. In the Armored Republic there is no King but Christ. We are Free Craftsmen. Body Armor is a Tool of Liberty. We create Tools of Liberty. Free men must remain ever vigilant against tyranny wherever it appears. God has given us the tools of liberty needed to defend the rights He bestowed to us. Armored Republic is honored to offer you those Tools. Visit them, at ar500armor.com https://thepostmillennial.com/bidens-railway-deal-to-avert-strike-spiked-by-union?utm_campaign=64487 Biden's railway deal to avert strike spiked by union Nearly a month after President Biden announced that a deal had been reached between railroad companies and their unions, the deal has fallen apart, raising concerns for a possible strike. The Brotherhood of Maintenance of Way Employees Division of the Teamsters, one of the nation’s largest railroad unions, rejected the deal on Monday, expressing discontent with the number of paid sick days, according to the Washington Post. Officials said that members of the third-largest union rejected the proposed five-year contract in a 56 to 43 percent split. Both sides have agreed to continue with negotiations until at least November 19. Railroads are currently expected to continue operating normally. The deal included a 24 percent increase in pay by 2024, as well as $1,000 annual bonuses for employees over five years. The plan ensured that healthcare co-pays would not increase in price, but included only one paid sick day compared to the 15 days union leaders pushed for. The deal followed two years of negotiations between the rail carriers and unions, which prompted the White House to appoint an emergency board in July to mediate between the two groups. In September, Biden applauded the tentative deal reached, calling it "an important win for our economy and the American people." Now, it’s time for my favorite topic, sports! Let’s catch up with what’s happening in the world of football shall we? First in the college ranks: #3 Alabama 24 Texas A&M 20 #2 Ohio State 49 Michigan State 20 #1 Georgia 42 Auburn 10 #15 NC State 19 Florida State 17 Texas 49 OU 0 #13 TCU 38 #19 Kansas 31 #7 USC 30 WSU 14 NFL: Giants 27 Packers 22 Chargers 30 Browns 28 Jets 40 Dolphins 17 Bills 38 Steelers 3 Cowboys 22 Rams 10 Chiefs 30 Raiders 29 So that’s what you may have missed over the weekend: This has been your CrossPolitic Daily News Brief. If you liked the show, hit that share button for me down below. If you want to come to our conference next year, if you want to sign up for a club membership, or sign up for a magazine subscription, you can do all of that at fightlaughfeast.com. As always, if you’d like to email me a news story, ask about our conference, or become a corporate partner of CrossPolitic, email me, at garrison@fightlaughfeast.com. For CrossPolitic News, I’m Garrison Hardie. Have a great day, and Lord bless.

This is Garrison Hardie with your CrossPolitic Daily News Brief for Wednesday, October 12th, 2022. I just got back from our Fight Laugh Feast Conference in Knoxville TN, and we announced while we were out there, where our next conference will be at the Ark Encounter next year! So stay tuned for when registration will open up, and we hope to see you and your family out in Kentucky, October of next year. Also, FLF Magazine: We are on a mission to make magazines great again. So, subscribe to our Fight Laugh Feast magazine. This is a quarterly mini-book like experience, packed full of a variety of authors that includes theologically-driven cultural commentary, a Psalm of the quarter, recipes for feasting, laughter sprinkled throughout the glossy pages, and more. Sign your church up, sign your grumpy uncle up, and while you are at it…sign up the Pope, Elon Musks, and Russel Moore. Disclaimer: This magazine will guarantee various responses and CrossPolitic is not held liable for any of them. Reading the whole magazine may cause theological maturation, possibly encourage your kids to take the Lord’s Supper with you, and will likely cause you to randomly chuckle in joy at God’s wondrous world. Sign up today! Four issues and $60 per year, that is it. Go to fightlaughfeast.com right now to sign up!. Now, here’s what you may have missed over the weekend. https://www.dailywire.com/news/colorado-officials-incorrectly-sent-out-30000-voter-registration-postcards-to-noncitizens Colorado Officials ‘Incorrectly’ Sent Out 30,000 Voter Registration Postcards To Noncitizens Colorado officials claim they accidentally sent approximately 30,000 postcards last month to noncitizens instructing them how they could register to vote. First reported by Colorado Public Radio News, Democratic Secretary of State Jena Griswold’s office said department employees had sent the postcards on Sept. 27 after comparing a list of 102,000 names provided by the Electronic Registration Information Center, a nonprofit organization aiming to improve U.S. voter rolls and advocating residents to vote. “The Department has become aware that approximately 30,000 EBU [Eligible But Unregistered] postcard mailers were incorrectly sent to ineligible Coloradans,” a spokesperson for the Colorado Secretary of State’s Office told local media. “The office is undertaking an internal review of the incident and will take any corrective action that is warranted.” Griswold insisted noncitizens would not be allowed to register to vote. The postcards, which the office printed in English and Spanish, read, “A message from Colorado Secretary of State Jena Griswold . . . Our records indicate that you or your household may be eligible to vote, but do not appear to be registered at your current address.” The mailers did include that to vote that residents must be 18 years old by Election Day, a United States citizen, and a Colorado resident for at least 22 days before the upcoming election, according to Colorado Public Radio News. Griswold’s office said they plan on sending out correction mailers to the noncitizens, “reminding them that only those that meet the above requirements are eligible to register.” According to local media, while the office had compared the list of potential unregistered voters to local DMV records, the data had included noncitizen drivers with Colorado driver’s licenses which the state issues for noncitizens to drive legally. The National Council on State Legislatures website shows Colorado as one of at least 17 states, along with the District of Columbia, that issue driver’s licenses to non-U.S. citizens. However, the system did not distinguish their eligibility to vote. Sean Morales-Doyle, director of the Voting Rights Program at the Brennan Center for Justice, told The Journal that the system making a mistake indicates it works. Griswold is up for reelection in the November midterms, where she will face Republican Pam Anderson, the head of the state’s county clerks association. https://www.theepochtimes.com/exclusive-cdc-wont-release-review-of-post-vaccination-heart-inflammation_4786038.html?utm_source=partner&utm_campaign=BonginoReport&src_src=partner&src_cmp=BonginoReport CDC Won’t Release Review of Post-Vaccination Heart Inflammation The U.S. Centers for Disease Control and Prevention (CDC) will not release its review of post-COVID-19-vaccination heart inflammation. The CDC has been performing abstractions on reports of post-vaccination myocarditis, a form of heart inflammation, submitted to the Vaccine Adverse Event Reporting System. But the agency is saying that federal law prevents it from releasing the results. The abstractions “are considered medical records which are withheld in full from disclosure,” the CDC told The Epoch Times in a recent letter, responding to a Freedom of Information Act request. One of the exemptions in the act says that agencies can withhold materials that are “specifically exempted from disclosure by statute, if that statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld; and (B) if enacted after the date of enactment of the OPEN FOIA Act of 2009, specifically cites to this paragraph.” The CDC pointed to the Public Health Service Act, which was enacted in 1944, and says that vaccine injury reports and other information that may identify a person shall not be made available to any person except the person who received the vaccine or a legal representative for that person. The information sought is available through the CDC website without details that would identify patients, the agency also said. The CDC said that it does not have a formal definition of “abstraction” but that it means the process of reviewing medical records, including autopsy reports and death certificates, and recording data in a database. “Please note that this definition means that any abstracted data, because they originate from medical records, is also considered medical records,” a CDC records officer told The Epoch Times in an email. Refusing to release the data raises concerns about transparency, according to Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center. “The stubborn refusal of officials heading up federal health agencies responsible for protecting the public health to come clean with Americans about what they know about COVID vaccine risks is stunning,” Fisher told The Epoch Times in an email. Fisher noted that the CDC has funded electronic medical record systems that collect personal health information and that the agency shares the data with a number of third parties, such as contractors and researchers. Fisher called for a congressional probe into what she described as “the disturbing lack of transparency on the part of federal agency officials, who granted COVID vaccine manufacturers an Emergency Use Authorization (EUA) to widely distribute the vaccines in December 2020 and have recommended and aggressively promoted the vaccines for mandated use ever since.” In response to a separate Freedom of Information Act request, the CDC initially said that it did not perform any abstractions or produce any reports on post-vaccination myocarditis. That request was for reports between April 2, 2021, and Oct. 2, 2021. The agency also falsely said that a link between myocarditis and the messenger RNA COVID-19 vaccines was not known during that time. A possible link between those vaccines, made by Pfizer and Moderna, became known in early 2021. Many experts now acknowledge the link is likely or definitely causal. Dr. Rochelle Walensky, the CDC’s director, said in a press conference in April 2021 that the agency had not detected a link between the vaccines and myocarditis. The basis for that statement remains unclear. The CDC still hasn’t released the results of the data mining, to The Epoch Times, Sen. Ron Johnson (R-Wis.), or a nonprofit called Children’s Health Defense. The agency also declined to provide results from a different monitoring system, V-safe, to a nonprofit called Informed Consent Action Network, which then sued the agency and just recently received the first tranche of data. The FDA, meanwhile, has refused to release the results of a different type of analysis on the VAERS data, claiming it cannot separate the results from protected internal communications. The agency is also withholding autopsies conducted on people who died after getting COVID-19 vaccines, pointing to exceptions laid out in the Freedom of Information Act. Along with Johnson, several other lawmakers are pressing at least one of the agencies to release the data, asserting that not doing so is illegal. https://www.breitbart.com/politics/2022/10/10/nike-co-founder-phil-knight-donates-1-million-to-republican-oregon-gov-candidate-christine-drazan/ Nike Co-Founder Phil Knight Donates $1 Million to Republican Oregon Gov. Candidate Christine Drazan Knight’s donation to Drazan’s campaign comes after he donated $3.75 million to Independent candidate Betsy Johnson, signaling his strong dislike for Tina Kotek. Republican strategist Rebecca Tweed told KGW Knight’s donation said the two donations are not meant as an endorsement of either candidate but rather an attack against the Democrat candidate. The donation comes as Christine Drazan stands within striking distance of unseating Kotek in a deep blue state that has not elected a Republican governor since Vic Atiyeh in 1982. As Breitbart News reported last week, a recent Emerson College poll showed the Oregon House Republican leader actually leading Koteck by two points – 36 percent to 34 percent. A new Emerson College Polling survey shows former Oregon House Republican leader Drazan ahead of former state House Speaker Tina Kotek (D)–36 percent to 34 percent. Nineteen percent of those polled plan to vote for former Democrat state senator-turned independent Betsy Johnson. The poll was conducted between Sept. 30 – Oct. 1 with 796 very likely Oregon voters. The survey’s Credibility Interval (CI), similar to a margin of error, is ±3.4 percentage points. KGW political analyst Len Bergstein concurred with Rebecca Tweed that Phil Knight’s donation should be seen as a knock against Kotek by potentially putting Drazan on the path to victory. “As soon as he sees some polls that say ‘wait a minute, there’s a chance that Drazan could win,’ he’s saying well maybe my money could make the difference to push her over the top,” said Bergstein. “This is not a normal election. We’re having fun watching it because we have three original candidates for governor and a lot of interesting twists and turns in the race already,” Bergstein added. Armored Republic The Mission of Armored Republic is to Honor Christ by equipping Free Men with Tools of Liberty necessary to preserve God-given rights. In the Armored Republic there is no King but Christ. We are Free Craftsmen. Body Armor is a Tool of Liberty. We create Tools of Liberty. Free men must remain ever vigilant against tyranny wherever it appears. God has given us the tools of liberty needed to defend the rights He bestowed to us. Armored Republic is honored to offer you those Tools. Visit them, at ar500armor.com https://thepostmillennial.com/bidens-railway-deal-to-avert-strike-spiked-by-union?utm_campaign=64487 Biden's railway deal to avert strike spiked by union Nearly a month after President Biden announced that a deal had been reached between railroad companies and their unions, the deal has fallen apart, raising concerns for a possible strike. The Brotherhood of Maintenance of Way Employees Division of the Teamsters, one of the nation’s largest railroad unions, rejected the deal on Monday, expressing discontent with the number of paid sick days, according to the Washington Post. Officials said that members of the third-largest union rejected the proposed five-year contract in a 56 to 43 percent split. Both sides have agreed to continue with negotiations until at least November 19. Railroads are currently expected to continue operating normally. The deal included a 24 percent increase in pay by 2024, as well as $1,000 annual bonuses for employees over five years. The plan ensured that healthcare co-pays would not increase in price, but included only one paid sick day compared to the 15 days union leaders pushed for. The deal followed two years of negotiations between the rail carriers and unions, which prompted the White House to appoint an emergency board in July to mediate between the two groups. In September, Biden applauded the tentative deal reached, calling it "an important win for our economy and the American people." Now, it’s time for my favorite topic, sports! Let’s catch up with what’s happening in the world of football shall we? First in the college ranks: #3 Alabama 24 Texas A&M 20 #2 Ohio State 49 Michigan State 20 #1 Georgia 42 Auburn 10 #15 NC State 19 Florida State 17 Texas 49 OU 0 #13 TCU 38 #19 Kansas 31 #7 USC 30 WSU 14 NFL: Giants 27 Packers 22 Chargers 30 Browns 28 Jets 40 Dolphins 17 Bills 38 Steelers 3 Cowboys 22 Rams 10 Chiefs 30 Raiders 29 So that’s what you may have missed over the weekend: This has been your CrossPolitic Daily News Brief. If you liked the show, hit that share button for me down below. If you want to come to our conference next year, if you want to sign up for a club membership, or sign up for a magazine subscription, you can do all of that at fightlaughfeast.com. As always, if you’d like to email me a news story, ask about our conference, or become a corporate partner of CrossPolitic, email me, at garrison@fightlaughfeast.com. For CrossPolitic News, I’m Garrison Hardie. Have a great day, and Lord bless.

Todos Medical Ltd. (OTCQB:TOMDF) CEO Gerald Commissiong tells Proactive's Stephen Gunnion that the company has completed a key milestone in its joint venture with NLC Pharma, with the transfer of its Tollovir, Tollovid, and TolloTest intellectual property to 3CL Pharma Ltd. Commissiong said 3CL Pharma will now prepare to launch a crowdfunding campaign to fund an Emergency Use Authorization (EUA) submission to the US Federal Drug Administration (FDA) for Tollovir in the treatment of hospitalized, severe to critical COVID-19 patients, the clinical development of Tollovir, Tollovid and TolloTest in Long COVID, as well as a national marketing campaign for Tollovid to support US sales. He also highlighted news that Tollovid has featured in the latest issue of Wellness Magazine.

William Morice II, M.D., Ph.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic and president of Mayo Clinic Laboratories, joins "Answers From the Lab" for his weekly leadership update with host Bobbi Pritt, M.D. In this episode, Dr. Pritt and Dr. Morice discuss how monkeypox can be transmitted, the possibilities of a future Emergency Use Authorization (EUA), and access to testing.

Steve Kirsch, a Democrat megadonor, joins Fox News to drop and absolute BOMBSHELL regarding vaccine deaths. This is the first time the truth about the COVID vaccine was talked about on ANY cable news station. Could this be the event that saves us? A whistleblower from the U.S. Military called a Pfizer representative to confirm the COVID vaccine was from the USA as required under the Emergency Use Authorization ("EUA"). The Pfizer representative told Chad that the Pfizer shot Lot# FW1331 was manufactured in France. This means the vials that the Coast Guard has are not FDA Approved! This might mean we are under attack. Check out Part I of this mRNA miniseries on "The Jonathan Kogan Show" wherever you get your podcasts! Nuremberg 2.0 Trial (Opening Statement): https://anchor.fm/jsk/episodes/Nuremberg-2-Trials-Have-Begun----64-e1mieul Rumble - https://rumble.com/v1fte3z-bombshell-on-fox-news-and-pfizer-whistleblower.html Brand New Tube - https://brandnewtube.com/watch/bombshell-dropped-on-fox-news-amp-military-whistleblower-on-pfizer_2z8DlfhMUWzr3lf.html References - https://elink.io/p/covid-vaccines-974ba4e Podcast - https://anchor.fm/jsk/episodes/BOMBSHELL-dropped-on-Fox-News--Military-WHISTLEBLOWER-on-Pfizer-e1mevhp --- Send in a voice message: https://anchor.fm/jsk/message Support this podcast: https://anchor.fm/jsk/support ★ Support this podcast on Patreon ★

Steve Kirsch, a Democrat megadonor, joins Fox News to drop and absolute BOMBSHELL regarding vaccine deaths. This is the first time the truth about the COVID vaccine was talked about on ANY cable news station. Could this be the event that saves us? A whistleblower from the U.S. Military called a Pfizer representative to confirm the COVID vaccine was from the USA as required under the Emergency Use Authorization ("EUA"). The Pfizer representative told Chad that the Pfizer shot Lot# FW1331 was manufactured in France. This means the vials that the Coast Guard has are not FDA Approved! This might mean we are under attack. Check out Part I of this mRNA miniseries on "The Jonathan Kogan Show" wherever you get your podcasts! Nuremberg 2.0 Trial (Opening Statement): https://anchor.fm/jsk/episodes/Nuremberg-2-Trials-Have-Begun----64-e1mieul Rumble - https://rumble.com/v1fte3z-bombshell-on-fox-news-and-pfizer-whistleblower.html Brand New Tube - https://brandnewtube.com/watch/bombshell-dropped-on-fox-news-amp-military-whistleblower-on-pfizer_2z8DlfhMUWzr3lf.html References - https://elink.io/p/covid-vaccines-974ba4e Podcast - https://anchor.fm/jsk/episodes/BOMBSHELL-dropped-on-Fox-News--Military-WHISTLEBLOWER-on-Pfizer-e1mevhp --- Send in a voice message: https://anchor.fm/jsk/message Support this podcast: https://anchor.fm/jsk/support ★ Support this podcast on Patreon ★

In the midst of the COVID-19 pandemic, an informal cross-industry collaboration developed to share information and best-practices as they chartered into the unfamiliar territories of Emergency Use Authorization (EUA), the process, planning and preparation of the MI teams during a global pandemic. This podcast, a continuation from Episode 1, will discuss the What of the collaboration– the specific topics covered by phactMI, a nonprofit collaboration of Medical Information leaders. Objectives: The objectives for this podcast series are: Discuss the impact the conversations in the group had on your workstream and with your internal business stakeholders Identify the major lessons learned through the collaboration Discuss how these lessons can be applied in the future 

In the midst of the COVID-19 pandemic, an informal cross-industry collaboration developed to share information and best-practices as they chartered into the unfamiliar territories of Emergency Use Authorization (EUA), the process, planning and preparation of the MI teams during a global pandemic. This podcast will discuss the how and why this group of MI professionals, who are part of phactMI, a nonprofit collaboration of Medical Information leaders, came together and the lessons learned from their collaboration.  Objectives: The objectives for this podcast series are: Describe the motivation of the companies to participate in a collaboration. List the reasons for the collaboration to form. Identify the goals for the collaboration. Discuss the impact the conversations in the group had on your workstream and with your internal business stakeholders Identify the major lessons learned through the collaboration Discuss how these lessons can be applied in the future 

Hour 1 * Guest: Richard Mack Founder and President of CSPOA – A partnership between citizens and local law enforcement, especially sheriffs. Mack encourages those not in law enforcement to stand with their sheriffs. – CSPOA.org * Juneteenth: Only 24 States Give Workers the Day Off Since Biden Declared a Federal Holiday in 2021. * Red flag laws are Unconstitutional! * Police in Uvalde, Texas, never attempted to unlock the door to two classrooms where a gunman shot and killed 21 people on May 24, the San Antonio Express-News reported. * Joe Biden Releases Over 1 Million Illegal Border Crossers into US Since Taking Office. * Airlines continue canceling flights, blame bad weather and pilot shortage – Thousands of flights cancelled over holiday travel chaos. * Can Ron Beat Don in 24 or Will Mitt get the Prize? * Pentagon FINALLY Admits, 46 US Funded Bio Labs in Ukraine – After months of denials as well as claims over and over again by fact-checkers that they were fake news, the pentagon has finally admitted that the US is helping fund and support bio-labs in Ukraine, and not a few, but 46. The same biolabs that up until last week we were told over and over again did not exist. * DeSantis: White House lying about COVID shots for kids – Governor ‘not surprised that legacy media would amplify the lie' – Art Moore, WND.com * This COVID shot will be available – NEVER! – ‘These drugs will not be manufactured' – WND.com * Health experts claimed that the Food and Drug Administration had “fully approved” the Pfizer Inc.-BioNTech COVID-19 shots called Comirnaty. But the drug company now has revealed they simply won't be available. * “As Liberty Counsel has stated from the beginning, there is no FDA approved COVID shot available. All COVID shots are under Emergency Use Authorization (EUA), which means people have the right to refuse them,” the legal team explained. Hour 2 * Hillary Clinton is refusing to back down from claims that she did not fairly win the 2016 presidential election, claiming in an interview published Friday that her losses in two key states were due to voter suppression. Clinton failed to provide any evidence for her claims. * Guests: Jennifer Orten and Sophie Anderson, Have put up an amazing fight for records, in Utah – Fighting Evil, and Exposing Corruption – TwoRedPills.org * Guest: Utah Rep. Phil Lyman – Lyman is a CPA and a member of the American Institute of Certified Public Accountants and has worked as an AICPA Personal Financial Specialist. * Utah Rep. Phil Lyman, of Blanding, introduced HB 371 that would return voting to in-person, paper ballot voting and place strict requirements on absentee ballots. * GOP state lawmaker Phil Lyman, who is sponsoring another bill that would implement regular audits, said his concerns go beyond the 2020 election and include funding for electronic systems where voter registration data in Utah and elsewhere is housed. * Two Utah Moms File Open Records Requests on Election Records – State Lt. Gov. Tips Off Reporter, Blocks Them from Access, and Feds Are Called In – Jim Hoft founder and editor of The Gateway Pundit. * Jen filed GRAMA requests with all 29 counties in Utah to secure those record before they were deleted. She asked for ballot images, cast vote records, tabulator data, drop box videos, and a copy of “Project” backup database. None of these contain private voter information. These are the election configurations and settings typically provided to auditors. * Even ESS Machines Have Modems, Documents Show – Alex Newman, Liberty Sentinel --- Support this podcast: https://anchor.fm/loving-liberty/support

* Guest: Richard Mack Founder and President of CSPOA - A partnership between citizens and local law enforcement, especially sheriffs. Mack encourages those not in law enforcement to stand with their sheriffs. - CSPOA.org * Juneteenth: Only 24 States Give Workers the Day Off Since Biden Declared a Federal Holiday in 2021. * Red flag laws are Unconstitutional! * Police in Uvalde, Texas, never attempted to unlock the door to two classrooms where a gunman shot and killed 21 people on May 24, the San Antonio Express-News reported. * Joe Biden Releases Over 1 Million Illegal Border Crossers into US Since Taking Office. * Airlines continue canceling flights, blame bad weather and pilot shortage - Thousands of flights cancelled over holiday travel chaos. * Can Ron Beat Don in 24 or Will Mitt get the Prize? * Pentagon FINALLY Admits, 46 US Funded Bio Labs in Ukraine - After months of denials as well as claims over and over again by fact-checkers that they were fake news, the pentagon has finally admitted that the US is helping fund and support bio-labs in Ukraine, and not a few, but 46. The same biolabs that up until last week we were told over and over again did not exist. * DeSantis: White House lying about COVID shots for kids - Governor 'not surprised that legacy media would amplify the lie' - Art Moore, WND.com * This COVID shot will be available – NEVER! - 'These drugs will not be manufactured' - WND.com * Health experts claimed that the Food and Drug Administration had "fully approved" the Pfizer Inc.-BioNTech COVID-19 shots called Comirnaty. But the drug company now has revealed they simply won't be available. * "As Liberty Counsel has stated from the beginning, there is no FDA approved COVID shot available. All COVID shots are under Emergency Use Authorization (EUA), which means people have the right to refuse them," the legal team explained.

Believe it or not COVID is still limping along vying for media coverage and your attention. The latest is coming for the youngest kids—6 months old to be exact. The FDA is pushing to…well heck, let's read it right from the agenda: This 2-day virtual meeting will be held to discuss recent requests to amend the Emergency Use Authorization (EUA) of the Moderna COVID-19 mRNA vaccine to include the administration of a primary series to infants, children, and adolescents 6 months through 17 years of age and to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of a primary series to infants and children 6 months through 4 years of age.   You can stop this from happening by making public comments. James Roguski has everything you need to know on today's show.    _________________________________   Support the Show  

Believe it or not COVID is still limping along vying for media coverage and your attention. The latest is coming for the youngest kids—6 months old to be exact. The FDA is pushing to…well heck, let's read it right from the agenda: This 2-day virtual meeting will be held to discuss recent requests to amend the Emergency Use Authorization (EUA) of the Moderna COVID-19 mRNA vaccine to include the administration of a primary series to infants, children, and adolescents 6 months through 17 years of age and to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of a primary series to infants and children 6 months through 4 years of age.   You can stop this from happening by making public comments. James Roguski has everything you need to know on today's show.    _________________________________   Support the Show  

Therma Bright Inc CEO Rob Fia tells Proactive it has submitted follow-up answers and reformatted data to the FDA for the company's Emergency Use Authorization (EUA) application for its AcuVid COVID-19 Rapid Antigen Saliva Test. The Toronto-based company said its executive and product development teams have been working with FDA officials to clarify answers to some of the EUA application questions, as well as provided some reformatting of data to better meet the application template requirements.

Big news coming out of NY, but we'll get to that in a second. Good Monday, this is the Chocolate Knox with your Crosspolitic Daily News Brief for Monday July 26th 2021 "In the beautiful town of Moscow, ID, Erber Automotive is looking for Christians to join forces and wage war together on broken cars. Since Adam's fall, cars have been suffering at the hand of the second law of thermodynamics, starting with that very first Eden Model 1 that Adam puttered out of the garden. Paul said that all creation groans, and he'd never even heard a poor car owner on the side of the road with a steaming engine! At Erber Auto, you'll work to make auto repair fun for customers with bouncy castles, motorcycle cruises, and honest service. Most importantly, you'll work alongside Christians to show entropy the Uno reverse card! Erber Auto is looking for service advisors, shop managers, and repair technicians, who are ready to do battle with the forces of evil, or at least metal fatigue. They have 4 positions to fill at competitive salaries. Please send your resume to business@erberauto.com." Remember you can send us news stories to news@crosspolitic.com NEWS LIKE THIS… Center for countering digital hate. https://www.counterhate.com/ https://252f2edd-1c8b-49f5-9bb2-cb57bb47e4ba.filesusr.com/ugd/f4d9b9_00b2ad56fe524d82b271a75e441cd06c.pdf Veterans Affairs to mandate COVID vaccine for health care personnel, first such mandate for federal agency Veterans Affairs Secretary Denis McDonough just today made COVID-19 vaccinations mandatory for all VA health care personnel, the first such mandate by a federal agency. The mandate includes physicians, dentists, nurses and others who work in patient-facing roles.  The VA said each employee will have eight weeks to be fully vaccinated. WHITE HOUSE SAYS COVID VACCINATIONS ‘PICKING UP' AMID CONCERNS OF DELTA VARIANT "We're mandating vaccines for Title 38 employees because it's the best way to keep Veterans safe, especially as the Delta variant spreads across the country," McDonough said Monday.  07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html Audience: Individuals Performing COVID-19 Testing Level: Laboratory Alert After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives. In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.

Outpatient Antiviral Treatment for COVID-19Whether you're a patient or a provider there are many considerations to know before taking or prescribing the new oral antiviral medications, Paxlovid, and molnupiravir. Indicated for the treatment of COVID-19, Paxlovid and molnupiravir are approved under the Emergency Use Authorization (EUA). Join me for a conversation with Drs. Tyler Melton and Brandon Hawkins, Pharm D, and assistant professors in the College of Pharmacy at the University of Tennessee Health Science Center as we discuss what you need to know about these medications. Paxlovid and molnupiravir, protease inhibitors, are highly effective in the treatment of COVID-19 in the outpatient setting but have very specific instructions for use. Drs. Melton and Hawkins discuss the drug-drug interactions with both medications, how long males and females must consider alternative methods of birth control during this drug administration and after, as well as both medications being limited to select pharmacy chains. More about Dr. Melton:Tyler Melton is an Assistant Professor in the Department of Clinical Pharmacy and Translational Science at the University of Tennessee Health Science Center (UTHSC), College of Pharmacy. He has ten years of pharmacy practice experience including inpatient and outpatient pharmacy in rural environments. Tyler joined UTHSC in September of 2020, after completing a postdoctoral research fellowship in Community Pharmacy Practice and Prescription Drug Abuse and earning his Master of Public Health from East Tennessee State University. His areas of research expertise include community pharmacy practice, ambulatory care, rural health, health disparities, and prescription drug misuse.More about Dr. Hawkins:Brandon K. Hawkins, PharmD, BCIDP, AAHIVP is an Assistant Professor in the Department of Clinical Pharmacy and Translational Science at the University of Tennessee Health Science Center College of Pharmacy. After obtaining his Doctor of Pharmacy from the University of Tennessee College of Pharmacy, he completed PGY1 Pharmacy Practice and PGY2 Infectious Diseases residencies at the University of Mississippi Medical Center. Dr. Hawkins maintains an active clinical practice at The University of Tennessee Medical Center supporting the infectious diseases consult service, antimicrobial stewardship practices, and precepting pharmacy students and residents. His research interests include microbiology-based stewardship interventions, as well as Gram-positive and immunocompromised infections. In addition to his clinical practice and scholarly activities, Dr. Hawkins serves on the Antimicrobial Stewardship Committee of the Society of Infectious Diseases Pharmacists.Websites:https://thatshealthful.com/ https://www.hhs.gov/coronavirus/covid-19-treatments-therapeutics/index.html https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19 https://www.fda.gov/media/155050/download#:~:text=5%20consecutive%20days.-,PAXLOVID%20may%20only%20be%20prescribed%20for%20an%20individual%20patient%20by,i.e.%2C%20anti%2Dinfectives) https://www.fda.gov/media/155054/download Twitter:@nowhealthful, @Lisa_APRN, @UTHSCnursingInstagram: @thatshealthful, @lbeasley0412, @uthscnursingHashtags:#COVID19, #Nursing, #Nurses, #collaboration, #pharmacy, #pharmacists, #antiviral, #publichealth, #vaccines, #vaccinatedThe “That's Healthful” podcast is hosted by Dr. Lisa Beasley, a Family Nurse Practitioner, and faculty in the College of Nursing at the University of Tennessee Health Science Center. Visit thatshealthful.com for more information or to hear prior episodes. Please follow @nowhealthful on Twitter and thatshealthful on Instagram. Like or comment on an episode wherever you listen or stream your favorite podcasts.Music for this episode is provided by local Memphis singer, musician, and songwriter – Devan Yanik. For more of Devan's music visit devanmusic.weebly.com.

It's important to recognize that when we're dealing with a very new or rapidly changing phenomenon, like we have been with the pandemic, even the "scientific consensus" can easily be wrong because there's not been much time for the rigorous replicability studies to be conducted or even sometimes to accurately measure the proper effect sizes. However, I also believe it's important that we don't create a false equivalency between very fringe ideas that are unsupported by the current evidence base and a scientific consensus that is grounded in rigorous methodology. This is why I sought out the counsel of Dr. Eric Topol on today's show. Despite being one of the top 10 most cited researchers in medicine and being extremely well regarded in his field of cardiology, he's also been a bright light on social media, shining a light on the best available evidence in the pandemic. He thoughtfully considered all my questions and was very careful to make clear what the current evidence base says without ruling out alternative possibilities in the future in light of new evidence. In this episode, we cover a number of hot button issues surrounding the pandemic including the potential use of ivermectin to end the pandemic, the potential for increased risk of myocarditis among certain populations after vaccination. We even discuss the role human psychology and human behavior have played in this pandemic. Ultimately, Dr. Topol is optimistic about the future of the pandemic and outlines things coming down the horizon that should give us hope. But as we discussed, the major problems tend to be human problems. BioEric Topol is a cardiologist, scientist, and author. He is the Founder and Director of the Scripps Research Translational Institute, Professor of Molecular Medicine, and Executive Vice-President of Scripps Research.As a researcher, he has published over 1200 peer-reviewed articles, with more than 290,000 citations, elected to the National Academy of Medicine, and is one of the top 10 most cited researchers in medicine. Dr. Topol has been voted as the #1 most Influential physician leader in the United States in a national poll conducted by Modern Healthcare. Besides editing several textbooks, he has published 3 bestseller books on the future of medicine: The Creative Destruction of Medicine, The Patient Will See You Now, and Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again.Website: drerictopol.comTwitter: @EricTopol Topics05:51 What is Emergency Use Authorization (EUA)?08:21 COVID-19 vaccines are humanity's greatest medical achievement12:05 Infection acquired immunity13:47 Vaccine and COVID induced myocarditis 16:56 The efficacy of booster shots 20:20 Ivermectin studies: what does the data say? 25:15 How to improve pandemic response30:02 Hope for the future of the pandemic 

Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do now to prepare?In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the recently released FDA draft guidance that describes transition plans for EUAs and how medical device companies should be preparing before EUAs are terminated by FDA.Some of the highlights of this episode include:EUA is one of many pathways that medical device companies can use to bring devices onto the market in the United States. EUA is a temporary authorization—not approval or clearance.The FDA has authorized more than 800 EUAs for medical devices for COVID-specific indications. The regulatory burden is lower for an EUA than a traditional approval.The FDA is reasonably expected to give companies a six-month notice for terminating EUAs. However, it takes much longer to get a 510(k), De Novo, or Premarket Approval (PMA) cleared.Quality versus Quantity: What is worse - not having enough ventilators, diagnostics or more ventilators, diagnostics that don't work? Both the regulatory and quality burden is higher for companies in the medical device industry.Certain shortcuts are justified in the short-term but not in the long-term. What companies did before for COVID/EUA medical devices is not enough now. Don't waste the FDA's time. The EUA needs to be a part of a company's overall regulatory strategy to determine how it fits into the bigger picture.Memorable quotes from this episode:“For those of you that have products that went through the EUA pathway to get to market, if you want to keep those products in the market post-EUA, there's things that you should be doing and frankly you should have already been doing them.” Jon Speer “The emergency use authorization or the EUA is one of many pathways to market that medical device companies can use to bring devices onto the market here in the U.S.” Mike Drues “Basically, it's a very, very special kind of pathway. It is not an approval. It is not a clearance. It's an authorization.” Mike Drues “If you're not building a plan, a strategy, and starting to execute that strategy, you're going to be leaving the market with your products.” Jon SpeerLinks:FDA issues draft guidance for transitioning medical devices granted EUAs during pandemicTransition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyTransition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyWebinar: How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?The End of EUA Is Coming SoonFDA - Medical Device OverviewMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

To vaccine or not to vaccine, that has become a polarizing question. But why is there censorship of early interventions and also of doctors writing scripts for them? Why are we being pitted against each other? Dr. Ruwart has been in the pharmaceutical industry for many years, run for the presidential primary on the Libertarian ticket, and is author of three books, one on how the FDA became what she thinks it is today. This is a tell-it-like-we-think-it conversation. Mary J. Ruwart, Ph.D. chairs a for-profit IRB and is a former research scientist in the pharmaceutical industry.  She has a B.S. in biochemistry and a Ph.D. in Biophysics from Michigan State University. She did post-doctoral work at the St. Louis University Medical School's Department of Surgery and became an Assistant Professor of Surgery before joining the Upjohn Company.  Science is always changing, and we are in a circumstance that is evolving, but it seems that the “narrative” of much of the media is not representing accurately both sides of the science. Turns out there are details not widely discussed on most TV or radio shows. You will hear some of that here including: Who is most apt to die from Covid and why. What does obesity have to do with it. Is heart damage happening more in vaccinated young adults than from Covid. Why getting two boosters a year exposes you to the “inflammatory spike” protein. The Covid spike protein binds to human tissues than any other animal the bat it derives from, and this is very unusual and makes us wonder about human gain-of-functioning engineering. We are seeing a level of censorship worldwide - bigger than we have ever seen before, even in the medical journals which are thus becoming untrustworthy now. So, in this show we ponder what is going on. Did you know that the Pfizer submission to FDA for Emergency Use Authorization (EUA) is still under EUA? The full approval has been for Biotech – in this show Dr. R. discusses the difference. You cannot have a vaccine on an EUA if there are already “early effective interventions”. Critical to keep in mind. We discuss the veracity of VAERS (Vaccine Adverse Event Reporting System) and why this is not being discussed, tracked, and Dr. R's interpretation of the numbers. Dr. Ruwart believes, teaches, and writes that “Whoever controls your body, controls your mind.” Think, read, question, debate, learn… but stay calm. And informed. Dr. Ruwart says, “If the vaccine works, then you don't need to worry about an unvaccinated person. If the vaccine doesn't work, it makes no sense to have a mandate. Especially with something so new.” Dr. Ruwart says the research on the children 5 to 12 years old was done on a group of 2000 children. None in the experiemental nor placebo arm during this time got Covid. 5% of the children were lost to follow-up. Is this enough safety data to inject our children? Dr. Ruwart says it is something to ponder. We discuss blood labs to see if heart damage is occurring and suggest nutraceuticals to take prophylactically, especially in children and young adults, that may be heart-protective - if you decide that moving forward is the best way to go. These are suggestions based on physiology, not studies. Many studies are included below for your personal reading. Dr. Ruwart's three books, “Healing Our World,” “Short Answers to the Tough Questions,” and “Death by Regulation” are available at Amazon.

Episode 72: Depression in Adolescents.  COVID-19 vaccine updates including booster shots and mix and match options. Depression in adolescents is discussed by Virginia Bustamante, Charizza Besmanos, and Hector Arreaza. Introduction: COVID Vaccines Update October 2021Written by Hector Arreaza, MD. Participation: Lillian Petersen, RN, and Nathan Heathcoat, MS3.  The FDA granted emergency use authorization for a booster shot with the Pfizer/BioNtech COVID-19 vaccine in September 2020.On October 20, 2021, the FDA also granted emergency use authorization for a booster shot with the Moderna AND Johnson & Johnson (also known as Janssen or J&J) COVID-19 vaccines. Pfizer/BioNtech: Brand name Comirnaty®. It has full FDA approval for patients who are 18 years and older for the prevention of COVID-19. The rest of the indications of this vaccine are under the Emergency Use Authorization (EUA). It is authorized for 12 years and older. Total of two doses, 21 days apart. Authorized for 3rd dose in immunocompromised patients (on active cancer treatment, organ transplant recipients, taking immunosuppressive or high dose corticosteroids, have moderate to severe immunodeficiency). 3rd dose is given at least 1 month after the second dose. It is authorized for a single booster shot in special populations (older than 65 years of age OR 18-64 years of age at high risk of severe COVID-19 or with frequent occupational exposure). The booster shot must be given 6 months after the primary series is complete.Moderna: No brand name yet. All uses are under emergency use authorization. It is authorized for 18 years and older for the prevention of COVID-19. Give a total of two doses, 4 weeks apart. A third dose is authorized to be given 1 month after the second dose. Patients who can receive a third dose include patients on active cancer treatment, organ transplant recipients, taking immunosuppressive or high dose corticosteroids, or have an immunodeficiency. It is authorized for a single booster shot 6 months after completing primary series. The booster shot of Moderna should be half dose. People who may receive a booster shot are those who are older than 65 years of age OR 18-64 years of age at high risk of severe COVID-19 or with frequent occupational exposure.Johnson & Johnson (Janssen): No brand name yet. Authorized as a single dose vaccine. Authorized for a single booster shot 2 months after the first dose. Mix and Match Approval: The FDA authorized on October 20, 2021, heterologous booster dose for currently approved or authorized COVID-19 vaccines. You can give a booster shot with a different vaccine than the one you received primarily. For example, a patient who received J&J vaccine may receive a booster shot with Pfizer or Moderna 2 months later. Another example, a patient received primary series of Pfizer vaccine, may receive a booster shot with Moderna, Pfizer or J&J 6 months after completing primary series. Booster shots are authorized, again, for patients who are 65 years and older, 18-64 years of age at high-risk for severe COVID-19 or with frequent occupational exposure.The vaccination of children 5-11 years old is still under discussion, more updates coming soon.This is Rio Bravo qWeek, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California. Our program is affiliated with UCLA, and it's sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home. ___________________________Depression in Adolescents. By Virginia Bustamante, MS4; Charizza Besmanos, MS4; and Hector Arreaza, MD.  Vicky: We will talk about adolescence and depression today. I was reading a piece on the Impact of COVID-19 Pandemic on Adolescent Mental Health on Psychiatry Advisor by Tori Rodriguez. She is a licensed professional counselor with a master's in arts in counseling psychology. This article really got me thinking, how prevalent is depression in adolescents? Even before COVID-19. I read the article and I wasn't even aware of the numbers. So, I decided to do some research on the topic. Charizza: When you brought up the topic for discussion, I asked myself how much do I even know? I found that the CDC reported that “more than 1 in 3 high school students had experienced persistent feelings of sadness or hopelessness in 2019.” This was a 40% increase since 2009. It also said that, “in 2019 about 1 in 6 youth reported making a suicide plan in in the past year. That was a 44% increase since 2009.” 44% increase! That is almost unbelievable. Now I'm asking myself what is causing such a drastic increase.Vicky: When I read Rodriguez's piece it really got me thinking. What is or are there even known causes linked to this huge increase?Charizza: Are adolescents more open to talk about mental illness? Or are there other factors affecting their mental illness? For example, increasing social media presence or other home/ social pressures. Vicky: Actually, that may be partially why. The U.S. News and World Report wrote a piece that highlighted the possible contributing factors that have led to this increase. They stated that data hasn't really shown a conclusive answer but there are some common themes that have emerged. And I'd like to spend much of this podcast really going into those themes and discussing them. The U.S. News and World Report listed five common themes. Theme one, what they called “a modern-day diagnosis” - where they reference a John Hopkins Health Review which explained that adolescent depression is somewhat of a new diagnosis. Charizza: Up until about the 1980's mental health professionals were reluctant to diagnose adolescents with a mood disorder. Because their brains were still developing, they thought it was not appropriate to diagnose someone so young with, for example depression. Vicky: Yes exactly, so the current thought is, that perhaps this change of thinking has played a part in the increasing numbers in the form of increased reporting and/or documentation. The second theme they listed was “hyper-connected & overstimulated.” This stems from how our world is today. Where electronic devices and social media are a big part of young people's lives. The idea that they have a life in the real world and the virtual world.  Charizza:  I read a study on Teens, Social Media and Technology, a Pew Research Center study, that more than 95% of teenagers have access to a smartphone and 45% of them described themselves as being online “almost constantly.”  Vicky: To think, how does this affect the way they see themselves? For maybe a lot of us listening right now we've been on social media. That could be Facebook, Instagram, Tik-Tok, and going way back Myspace. We know that social media can be an amazing place to share our lives but can also be filled with a lot of criticism.Arreaza: Have you heard of “FOMO”? It's “Fear of Missing Out”. It's a condition that can cause severe anxiety because others are having fun, or you missed a particular event, memorable experience, or an opportunity to connect with someone famous, or an online investment. People with FOMO need to stay always connected. Vicky: The Journal of Abnormal Psychology explained that the spike in depression and suicidal tendencies may be connected to social media among young people. They went on to describe how it's not uncommon for young people to measure their self-worth based on the likes. I've been there. Questioning myself whether to post or not post a picture based on whether it's “Instagram worthy”? Will it get enough likes to be posted? Rather than sharing moments of my life with friends and family as the platform was intended to. Charizza: It's not something I'm proud of but I've gotten sucked into the fake reality of online. That's why I reduced my social media presence. Vicky: Was there a specific reason or situation that led to that?Charizza: I just felt like that it was taking more energy than it was meant for. And honestly I've felt happier since not really using my Facebook anymore. Vicky: If that makes you happier, I support it. I mean I might consider it myself. Arreaza: Yes, a social media “fasting” may be beneficial for some people. Vicky: For the third theme, the article referred to what they called “uncertain times.”Charizza: What does that even mean?Vicky: Each generation is influenced and shaped, in a positive or negative way, by the events happening at that time in history. And sadly, today's young people have grown up in a post-9-1-1 world, mass terrorist attacks, and shootings whether that be high schools, malls, and even churches. All these events mean that young people may know the fear of terrorism. A sense of security has been taken from them by these awful and cowardly attacks of others. Charizza: I had a friend who was afraid to go to the movies after the 2012 Aurora Colorado shooting. For a long time, every time she went, she couldn't sit there and enjoy the movie. She kept turning around looking at the door every time it opened. Afraid something would happen. So, thinking of that and thinking that others may be going through similar and even more difficult times, I can completely understand this contributing depression among young people. Vicky: This fear and stress appears to be contributing to the increase in depression. The fourth theme was “not enough sleep.” The Nation Sleep Foundations recommends teens get 8.5 to 9.5 hours and instead teens get around 7 hours. When I am well rested, I perform my best. My energy, memory and overall mood is better. But with school, work, and everything else it's hard sometimes to get the hours I need. I mean I don't know about you Charizza, but I can work on getting more sleep. Charizza: Sadly, I struggle with it too. But for adolescents where they're still developing and undergoing different physiological changes those hours are especially important. The Sleep Foundation stressed the importance of sleep for teens. They talk about how it helps with physical development - with all the changes they are undergoing, academic achievement - by promoting attention, improving memory (like you brought up), and definitely helps with emotional health. The website states that mental health disorders for example anxiety, depression, and even bipolar disorder have been linked to poor sleep. They even stated that sleep deprivation in teenagers can increase the risk for suicide.Arreaza: A poor sleep also can lead to obesity in adolescents and adults. Something we should remember is also the timing of sleep for adolescents. The sleep pattern changes over the lifetime of people, and it's not only in duration, but also the time they sleep. Normally, a teenager tends to go to bed late and wake up late. For this reason, high school schedules are being changed in California to start at 8:00 AM. Vicky: It sounds like improving sleep in adolescents can be a great way of preventing mental health disorders or even reducing their symptoms. The last and fifth theme discussed in The U.S. News and World Report as a possible contributing factor to the increase in adolescent depression is a “lack of community.” This goes back to the world we live in today. We live with this - what the article quotes as - “go-go mentality” and the community we would have previously built or created around us have gotten smaller. So as they quoted “our face-to-face connections” have decreased.Charizza: Is there anything they suggest?Vicky: The U.S. Preventive Services Task Force recommends primary caregivers screen adolescents 12-18 for depression. But this doesn't always happen. They suggested that identifying adolescent depression should NOT be something that only falls on the medical provider but something we should ALL be responsible for. We can do this by building healthy and trusting relationships with our young people. Hopefully also rebuild this sense of community. Today we highlighted some themes that are possibly related to the increase in adolescent depression. Those were: the idea of a modern-day diagnosis, second being hyper-connected & overstimulated, third the uncertain times we live in, fourth not enough sleep, and lastly the sense of a lack of community. Charizza: We hope you guys all really enjoyed listening. And remember if you are or know someone struggling with depression and/or suicide thoughts reach out to someone. Let someone know how you are doing. Tell a teacher, adult, someone. Vicky: If you for whatever reason don't feel comfortable doing that or feel you may not have someone to reach out to and are in danger of hurting yourself or others please call 911. Charizza: There are also national suicide prevention hotlines. That is 1-800-SUICIDE and that's 1-800-SUICIDE. There is also 1-800-273-TALK, again that's 1-800-273-TALKVicky: There is also the Mary K Shell Mental Health Center with a walk-in crisis center. They are located here in Bakersfield on College and Mt. Vernon. They are actually in the same parking lot as Kern Medical Center. Their number is 661- 868-8123.________________________________Conclusion: Now we conclude our episode number 72 “Depression in Adolescents.” Our adolescent patients are a special population, so special that you can even do a fellowship after finishing your residency. Our adolescents are under a lot of pressure, especially during this era of social media. Remember to screen for depression and start treatment right away with behavioral therapy and medications as needed or refer your depressed patients to a psychiatrist to start treatment promptly. Do not forget to assess risk of suicide and act fast to prevent suicide in your patients. Even without trying, every night you go to bed being a little wiser.Thanks for listening to Rio Bravo qWeek. If you have any feedback about this podcast, contact us by email RBresidency@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. This podcast was created with educational purposes only. Visit your primary care physician for additional medical advice. This week we thank Hector Arreaza, Lillian Petersen, Nathan Heathcoat, Virginia Bustamante, and Charizza Besmanos. Audio edition: Suraj Amrutia. See you next week! _____________________References:Mental Health, Adolescent and School Health, Centers for Disease Control and Prevention, CDC.gov,  https://www.cdc.gov/healthyyouth/mental-health/index.htm, accessed on September 20, 2021.  Lohmann, Rachel Cassada, What's Driving the Rise in Teen Depression?, US News, April 22, 2019. https://health.usnews.com/wellness/for-parents/articles/2019-04-22/teen-depression-is-on-the-rise.  Anderson, Monica and Jingjing Jiang, Teens, Social Media and Technology 2018, Pew Research Center, May 31, 2018. https://www.pewresearch.org/internet/2018/05/31/teens-social-media-technology-2018/.  Rodriguez, Tori, Impact of the COVID-19 Pandemic on Adolescent Mental Health, Psychiatry Advisor, April 30, 2021, https://www.psychiatryadvisor.com/home/topics/child-adolescent-psychiatry/adolescent-mental-health-issues-are-further-exacerbated-by-the-covid-19-pandemic/. 

LexaGene Holdings, Inc. CEO Dr Jack Regan joined Proactive's Stephen Gunnion to share the news that the molecular diagnostics company continues to systematically advance its MiQLab System to meet the Food and Drug Administration (FDA) criteria for Emergency Use Authorization (EUA). The MiQLab System is a first of its kind, point of care diagnostic testing technology. Regan telling Proactive that the intent of the FDA requirements is to ensure vendors take the necessary steps to get the highest quality product possible out of their specific technology. He said LexaGene has made great progress and completed many of these requirements over the last few months.

Thank you for joining us for episode 18 of COVID Conversations. This series is a special presentation of OccPod, the official podcast of the American College of Occupational and Environmental Medicine. ACOEM is dedicated to sharing the latest COVID-19 news, and host conversations grounded in science with a focus on OEM, or occupational and environmental medicine. In this episode, Erin, Dr. Nabeel, and Dr. Berenji discuss current guidance – and the future implications – of COVID-19 booster shots. Although current guidance recommends additional doses for immunocompromised and older patients, their use could become widespread. Since December 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under Emergency Use Authorization (EUA). EUAs are used by the Food and Drug Administration (FDA) during public health emergencies to provide access to medical products that may be effective, provided that the FDA determines that the known and potential benefits of a product outweigh the known and potential risks. On August 23, 2021, the FDA issued a full approval for the vaccine, now marketed as Comirnaty, for use in individuals in ages 16 years of age and older. Thank you for listening!

Dr. Nirav Shah, ASTHO President and Director of the Maine Center for Disease Control and Prevention, discusses concerns of workshop participants about the way Emergency Use Authorization (EUA) decisions are communicated; Ericka McGowan, ASTHO's Senior Director of Emerging Infectious Disease, writes a blog article sharing seven things to know about vaccines for pregnant people; Priyanka Surio, ASTHO's Senior Director for Public Health Data Modernization and Informatics, reviews a new report assessing data collection related to Neonatal Abstinence Syndrome; and ASTHO promotes key job openings. The National Academies Webpage: FDA EUA Workshop ASTHO Blog Article: Pregnancy, breastfeeding, and COVID-19 vaccines – Seven things to know ASTHO Report: Strengthening health agencies' Neonatal Abstinence Syndrome surveillance through consensus-driven data standards and practices ASTHO Webpage: Job opportunities in public health and at ASTHO

On August 23, the Food and Drug Administration (FDA) in the US approved the Pfizer BioNTech vaccine, the fastest approval in the agency's history. This means the shot is no longer only in use under the Emergency Use Authorization (EUA) and opens the door for vaccine mandates by employers, universities and the military, and gives doctors flexibility in using vaccinations for "off-label use," like giving booster shots. But the approval has been far from straight forward. Firstly, the FDA did...

On August 23, the Food and Drug Administration (FDA) in the US approved the Pfizer BioNTech vaccine, the fastest approval in the agency's history. This means the shot is no longer only in use under the Emergency Use Authorization (EUA) and opens the door for vaccine mandates by employers, universities and the military, and gives doctors flexibility in using vaccinations for "off-label use," like giving booster shots. But the approval has been far from straight forward. Firstly, the FDA did...

Thank you for joining us for episode 16 of COVID Conversations. This series is a special presentation of OccPod, the official podcast of the American College of Occupational and Environmental Medicine. ACOEM is dedicated to sharing the latest COVID-19 news, and host conversations grounded in science with a focus on OEM, or occupational and environmental medicine. In this episode, Erin, Dr. Nabeel, and Dr. Berenji discuss implications of the FDA's Pfizer-BioNTech COVID-19 vaccine approval. Drs. Nabeel and Berenji are joined for this episode by special guest Dr. Tanisha Taylor. Since December 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under Emergency Use Authorization (EUA). EUAs are used by the Food and Drug Administration (FDA) during public health emergencies to provide access to medical products that may be effective, provided that the FDA determines that the known and potential benefits of a product outweigh the known and potential risks. On August 23, 2021, the FDA issued a full approval for the vaccine, now marketed as Comirnaty, for use in individuals in ages 16 years of age and older. Thank you for listening!

Daily News Brief for Wednesday September 1st, 2021 Folks we are just a week away from our Fight Laugh Feast Conference in Tennessee...just 8 days! So, if you cannot physically make it to the conference, we still have you covered! Join our club, and we will be living streaming all the talks in our club portal and in our app! So, go to FightLaughFeast.com. This is like saying, we lit a house on fire, and then rescued 40%. An amazing evacuation. American University of Kabul students trying to flee couldn't get to airport https://thehill.com/policy/international/569934-american-university-of-kabul-students-trying-to-flee-couldnt-get-to According to the Hill: “Students and alumni of the American University of Afghanistan (AUAF) attempting to flee the country found they were unable to enter the Hamid Karzai International Airport, The New York Times reported. According to the Times, current and former students of AUAF gathered a safe house on Sunday and rode on buses to the Kabul airport. However, the were informed after seven hours of waiting for clearance that the airport gates were a security threat and that civilian evacuations would end on Monday, the Times reported. “I regret to inform you that the high command at HKIA in the airport has announced there will be no more rescue flights,” the AUAF administration told students in an email, according to the Times. The group was also told the university had given their names to Taliban militants running checkpoints around the airport, the Times reported. “We are all terrified, there is no evacuation, there is no getting out," a 24-year-old sophomore at AUAF told the Times. AUAF president Ian Bickford left the campus when it was shut down shortly after the Taliban takeover of Kabul along with other foreign staff members. The Times reported that Bickford said he is working with the State Department to ensure the evacuation of over a thousand current and former students, though last week's attack on the airport has complicated this effort. The State Department declined comment, citing privacy concerns for the individuals involved.” Meanwhile: Taliban commit 'house-to-house executions' in Kabul after US exit as chilling audio demonstrates Afghans' fear https://www.foxnews.com/world/taliban-kabul-executions-afghanistan-gunshots-audio?cmpid=fb_fnc Play Audio: According to Fox: “Taliban militants were carrying out "house-to-house executions in Kabul" after the U.S. departure, a senior U.S. source told Fox News Investigative journalist Lara Logan. President Biden did not deny a Politico report, confirmed by Fox News, that U.S. officials in Kabul gave the Taliban a list of American citizens, green card holders, and Afghan allies in an effort to grant them entry to the airport which resulted in outrage from military officials behind the scenes. The president said "there may have been" such a list. "Basically, they just put all those Afghans on a kill list," one defense official told Politico. Hours after the departure of U.S. troops, the official Taliban Twitter account celebrated the withdrawal. "The last American soldier left Kabul airport at 9pm Afghan time tonight and our country gained full independence. Thank God and blessings," the Taliban account tweeted. “ This came from, get this: Official Twitter Account of the Spokesman of Islamic Emirate of Afghanistan, Zabihullah Mujahid But Trump's tweets were mean. Plug: " Let's talk about self defense and firearms. Jesus commanded in Luke 22:36 “he that hath no sword, let him sell his garment, and buy one”; should we likewise carry a pistol and defend those we love? Shan and his team at Werkz specialize in concealed carry holsters for pistols with lights. They believe defensive pistols should have a light and a holster because violent encounters often happen outside the home, and in the dark. Werkz offers holsters for 1,274 pistol and light combinations, plus can help outfit your pistol with a light. Go to Werkz.com/CrossPolitic and be prepared to defend day and night." Israel registers almost 11,000 COVID cases, marking new record https://www.jpost.com/health-and-wellness/israel-registers-almost-11000-cases-in-a-day-marking-new-record-678227 Israel has over 60% vaccination rate, one of the highest in the world (US at 53%), and yet here you go. According to the Jerusalem Post: “Israel registered close to 11,000 COVID-19 cases on Monday, the Health Ministry reported Tuesday, marking a new record since the start of the pandemic. The number of patients in serious condition has remained stable, but with the new school year set to begin on Wednesday, officials fear there will be a further increase in infections. “I expect that morbidity will rise further, but I hope it will not be a new outbreak,” Health Ministry Director-General Nachman Ash told Channel 12. At least 10,947 new virus carriers were identified on Monday, with 7.65% of people tested returning a positive test. On only one other occasion since the beginning of the pandemic has the country recorded more than 10,000 cases. There were 10,118 on January 18, during the peak of the third wave, the most virulent and deadliest the country experienced.” FDA Does a Bait and Switch with COVID Shots https://lc.org/newsroom/details/082721-fda-does-a-bait-and-switch-with-covid-shots This article come from Liberty Council: The Food and Drug Administration (FDA) has done a bait and switch by announcing it approved its “first COVID-19 vaccine” in order to push the “vaccine” mandates and protect the Pfizer pharmaceutical company from legal liability. However, there is currently no fully licensed COVID shot on the United States market. Albeit confusing, and probably intentionally so, this summarizes the current status of the Pfizer-BioNTech shots: All existing Pfizer vials (in the hundreds of millions), remain under the federal Emergency Use Authorization (EUA) (meaning people have the “option to accept or refuse”);The third or “booster” Pfizer shot is identical to the above and remains under the EUA with limited use to certain categories of people;BioNTech received FDA approval for people ages 16 and above under the name Comirnaty, but there are no Comirnaty doses available in the United States;In other words, there is currently NO FDA approved COVID-19 injection available anywhere in the United States. Every COVID shot in America remains under the EUA law and thus people have the “option to accept or refuse” them; andEven when an FDA approved COVID shot becomes available, individuals are protected by federal law and many states laws from being forced to get these shots based on their sincere religious beliefs or conscience rights. Despite whether these COVID shots are licensed or not, they cannot be mandatory under Title VII. In general, employee vaccine religious exemption requests must be accommodated, where a reasonable accommodation exists without undue hardship to the employer, pursuant to Title VII of the Civil Rights Act of 1964. Many people hold sincere religious beliefs against taking the COVID shots or taking those derived from or which used at any stage of the development aborted fetal cell lines. Liberty Counsel Founder and Chairman Mat Staver said, “The FDA has apparently tried to deceive people by issuing its two confusing letters without proper explanation. Despite the FDA's sleight of hand, there is currently no FDA approved COVID shot available in the United States. Even if there were an FDA approved COVID shot available, people still may request that employers, schools, and the military accommodate their sincerely held religious beliefs.” Gabriel Gipe, Public high school teacher at Inderkum High School in Sacramento, CA had this to say about discipling children: Play clip: https://youtu.be/83b_u5V51U8 Kanye, Kirk Cameron lending support to faith-based crowdfunding nature series 'The Riot and the Dance' https://www.christianpost.com/entertainment/first-faith-based-nature-series-the-riot-and-the-dance.html According to the Christian Post: "The Riot and the Dance" is following in the footsteps of “The Chosen" by inviting viewers to invest in bringing to life a nature series that shows creation was intentionally designed by a divine Creator. Dubbing itself the “first high production” nature series, the show specializes in acknowledging God's hand in the beauty of nature. While most mainstream nature series ignore or deny God's involvement in creation, “The Riot and the Dance” is overt in its Christian messaging. In the show's pilot episode, host Gordon Wilson, a scientist and devout Christian, talks about Jesus and baptism while exploring the beauty of nature. “Working on ‘The Riot and The Dance' is more than a dream come true. For a scientist and animal lover, there's nothing like adventuring in the field. And now, thanks to our fantastic production crew, I can bring millions of families along for the ride, celebrating creation and the Artist behind every fantastic critter,” Wilson, who also hosted the successful documentaries “Earth” and “Water,” said in a statement shared with The Christian Post. He added: “Faith-based nature docs have never had space in the industry. I'm still amazed that such a shake up is really happening, and I'm beyond blessed to be a part of it.” Like the hit series “The Chosen,” which has generated over $70 million in crowdfunding, “The Riot and the Dance” has also partnered with Angel Studios for distribution. Show creators are giving viewers an opportunity to invest in the series. They are hoping to raise $5 million in 30 days to bring season one to life and send the team around the world. The show has also garnered the support of numerous celebrities, including Kirk Cameron, Kanye West, and "The Chosen" creator Dallas Jenkins. Roll clip: https://www.christianpost.com/entertainment/first-faith-based-nature-series-the-riot-and-the-dance.html Closing This is Gabriel Rench with Crosspolitic News. Support Rowdy Christian media by joining our club at fightlaughfeast.com, downloading our App, and head to our annual Fight Laugh Feast Conference next fall. With your partnership, together we will fight outdated and compromised media, engage news and politics with the gospel, and replace lies and darkness with truth and light. Go to fightlaughfeast.com to take all these actions. Have a great day. Lord bless

Covid has been the top story for over a year. Operation "Warp Speed" was put into effect to get the whole bio community to work together to come up with a vaccine. 3 Companies received Emergency Use Authorization (EUA) and finally, one company has full FDA approval. These stocks can really rocket! Big money is picking up on these plays and it's not too late to get on board the ship!Pfizer Full FDA Approval! To the Moon!!!!! - PFE Stock | VectorVestUse this link for a FREE Stock Analysis Report ➥➥➥ http://bit.ly/2KsZlqz

TOPICS by TIMECODE 12:48 FDA Approved? Comirnaty, Tozinameran and Legal Implications.  FDA extends the Pfizer vax Emergency Use Authorization (EUA) and approves Comirnaty (legally distinct). So what are the legal implications? 28:45 A lot of virtue signaling by GOP & governors about protecting us from mandates, but Montana is the ONLY state that prohibits employers from dictating vaccinations. 34:13 Governors are activating National Guard — why? 39:29 Trudeau in Canada and Newsom in California are actually running on lockdown, masks and vaccine mandates because they think they can win.  There is socialist solidarity on these authoritarian policies and a divided opposition. 49:49 More details and some comments on Gab's “No Vax Mandate Job Board” 56:55 Spain's Supreme Court shuts down the tyranny of VaccinePassports to access public space.  Court in India strikes down VaccineMandates as “both a crime and a tort”. 1:06:56 Listener's letters: Montana, local control, medical care outside the system, religious exemptions, military mandates, 1:19:17 US govt doesn't know, doesn't care how many Americans are left behind as word comes they're stopping Afghanistan civilians flights in 72 hrs to give military time to withdraw before Aug 31 1:30:05 Save the last bullet for yourself.  Taliban is coming for women, Christians 1:51:33 Is the GOP supporting ANY of our rights? Is anyone speaking out against FDA “authorization” or opposing corporate coercion of Trump Shots?  Here's the good, bad and the really ugly 2:01:43 Gov Kristi Noem of South Dakota — a special kind of hypocrite. 2:43:43  Listeners' letters:  A hypothetical restaurant conversation about VaccinePassports, life in Australia now 2:47:32 Ankle monitors for high school kids (contact tracing), OUTDOOR mask mandates return - even for the VAXED, up to 5 yrs & $5,000 fine for violating lockdown as elite politicians and university Presidents flaunt THEIR rules Find out more about the show and where you can watch it at TheDavidKnightShow.com If you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-show Or you can send a donation through Zelle: @DavidKnightShow@protonmail.com Cash App at:  $davidknightshow BTC to:  bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7 Mail:          David Knight          POB 1323          Elgin, TX 78621

TOPICS by TIMECODE12:48 FDA Approved? Comirnaty, Tozinameran and Legal Implications.  FDA extends the Pfizer vax Emergency Use Authorization (EUA) and approves Comirnaty (legally distinct). So what are the legal implications?28:45 A lot of virtue signaling by GOP & governors about protecting us from mandates, but Montana is the ONLY state that prohibits employers from dictating vaccinations.34:13 Governors are activating National Guard — why?39:29 Trudeau in Canada and Newsom in California are actually running on lockdown, masks and vaccine mandates because they think they can win.  There is socialist solidarity on these authoritarian policies and a divided opposition.49:49 More details and some comments on Gab's “No Vax Mandate Job Board”56:55 Spain's Supreme Court shuts down the tyranny of VaccinePassports to access public space.  Court in India strikes down VaccineMandates as “both a crime and a tort”.1:06:56 Listener's letters: Montana, local control, medical care outside the system, religious exemptions, military mandates,1:19:17 US govt doesn't know, doesn't care how many Americans are left behind as word comes they're stopping Afghanistan civilians flights in 72 hrs to give military time to withdraw before Aug 311:30:05 Save the last bullet for yourself.  Taliban is coming for women, Christians1:51:33 Is the GOP supporting ANY of our rights? Is anyone speaking out against FDA “authorization” or opposing corporate coercion of Trump Shots?  Here's the good, bad and the really ugly2:01:43 Gov Kristi Noem of South Dakota — a special kind of hypocrite.2:43:43  Listeners' letters:  A hypothetical restaurant conversation about VaccinePassports, life in Australia now2:47:32 Ankle monitors for high school kids (contact tracing), OUTDOOR mask mandates return - even for the VAXED, up to 5 yrs & $5,000 fine for violating lockdown as elite politicians and university Presidents flaunt THEIR rulesFind out more about the show and where you can watch it at TheDavidKnightShow.comIf you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-showOr you can send a donation throughZelle: @DavidKnightShow@protonmail.comCash App at:  $davidknightshowBTC to:  bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7Mail:         David Knight         POB 1323         Elgin, TX 78621

Hour 1 * Guest: Lowell Nelson – CampaignForLiberty.org – RonPaulInstitute.org. * Canada Adds Bell's Palsy Warning to Pfizer COVID Shot! * In a Dec. 22, 2020 article in The Vaccine Reaction, Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), reported that staff members of the US Food and Drug Administration (FDA) had recommended monitoring people who received Pfizer/BioNTech and Moderna/NIAID shots for Bell's palsy. Fisher noted that the recommendation had been made after the FDA staff had analyzed clinical trial data for both products used by the manufacturers to apply for an Emergency Use Authorization (EUA) to distribute the products in the US before full licensure. * Health Freedom Symposium 2021: Fri-Sat, Sep 10-11 – YourHealthFreedom.org. * Liberty Conference 2021: Fri-Sat, Oct 22-23 – Salt Palace in Utah – WeCANAct.net, Promo Code “Lowell”. * Kabul Has Fallen – But Don't Blame Biden – Ron Paul – Unless there is a major purge of those who lied and misled, we can count on these disasters to continue until the last US dollar goes up in smoke. “American citizens must also share some blame. Until more Americans rise up and demand a pro-America, non-interventionist foreign policy they will continue to get fleeced by war profiteers.” * Thomas Jefferson's Blueprint for Dealing With the National Debt – Reduce spending. * Biden's Other Unwinnable War – Jeffrey A. Tucker. Hour 2 * Guest: Dr. Scott Bradley – To Preserve The Nation – FreedomsRisingSun.com. * The US Food and Drug Administration granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older. This is the first coronavirus vaccine fully approved by the FDA, and is expected to open the door to more vaccine mandates. * FDA to give full approval to COVID vaccines; no public hearing; no transparency; no open review of vaccine data. * Jesse Jackson Hospitalized With COVID-19 After Being Fully Vaccinated! * Greta Thunberg: Biden Admin ‘Not Ready to Act as Seriously as We Need' on Climate Crisis. * Do we need the New Nuremberg Trials 2021? --- Support this podcast: https://anchor.fm/loving-liberty/support

* Guest: Lowell Nelson - CampaignForLiberty.org - RonPaulInstitute.org. * Canada Adds Bell's Palsy Warning to Pfizer COVID Shot! * In a Dec. 22, 2020 article in The Vaccine Reaction, Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), reported that staff members of the US Food and Drug Administration (FDA) had recommended monitoring people who received Pfizer/BioNTech and Moderna/NIAID shots for Bell's palsy. Fisher noted that the recommendation had been made after the FDA staff had analyzed clinical trial data for both products used by the manufacturers to apply for an Emergency Use Authorization (EUA) to distribute the products in the US before full licensure. * Health Freedom Symposium 2021: Fri-Sat, Sep 10-11 - YourHealthFreedom.org. * Liberty Conference 2021: Fri-Sat, Oct 22-23 - Salt Palace in Utah - WeCANAct.net, Promo Code "Lowell". * Kabul Has Fallen – But Don't Blame Biden - Ron Paul - Unless there is a major purge of those who lied and misled, we can count on these disasters to continue until the last US dollar goes up in smoke. "American citizens must also share some blame. Until more Americans rise up and demand a pro-America, non-interventionist foreign policy they will continue to get fleeced by war profiteers." * Thomas Jefferson's Blueprint for Dealing With the National Debt - Reduce spending. * Biden's Other Unwinnable War - Jeffrey A. Tucker.

Dissecting OLC's Indefensible Opinion on Vaccine Emergency Use Statute  In a highly publicized opinion recently made public, the U.S. Department of Justice's Office of Legal Counsel (OLC) argues that public and private entities can lawfully mandate that their employees receive one of the Covid-19 vaccines. The opinion is silent on preemption, however, and thus cannot be read to prevent the Emergency Use Authorization (EUA) statute from having its ordinary preemptive effect, and this is especially true where OLC was assigned no role by Congress to administer the EUA statute. The OLC opinion is deeply flawed on multiple additional legal grounds. The New CDC Eviction Moratorium Is Still Entirely Unlawful—And Worse Than the First One This week, CDC Director Walensky officially extended the eviction moratorium through Oct. 3. In a press release, the agency said the new order applies in "areas of high transmission" of Covid-19. In multiple lawsuits across the country, NCLA is arguing that the eviction moratorium far exceeds the constitutional and statutory limits of CDC's authority. The agency's radical and unprecedented interference with access to state courts has deprived Americans across the country of their constitutional right to resolve their legal disputes in court.   Last month, the U.S. Court of Appeals for the Eleventh Circuit rejected the request of Rick Brown of Virginia and other hard-hit housing providers across the country to put an end to the eviction moratorium issued by CDC. In a 2-1 decision in Brown, et al. v. CDC, et al., the panel affirmed the lower court's refusal to enjoin CDC's unlawful eviction moratorium. NCLA is carefully considering whether to appeal this adverse ruling to the U.S. Supreme Court or return to district court for trial. NCLA also filed a class-action lawsuit, Mossman v. CDC, in the U.S. District Court for the Northern District of Iowa. See omnystudio.com/listener for privacy information.

The Hake Report, Friday, July 23, 2021: LATE START — JUST 1-HOUR TODAY! // America's Frontline Doctors sue HHS to stop Emergency Use Authorization (EUA) for those under 18, the prior-infected, and those without informed consent. // 2018: GQ Magazine includes the Bible among "21 books you don't have to read" — Irish-Cicilian absurdist writer Jesse Ball instead suggests "The Notebook," by some deceased woman. // 2018: effeminate Antifa professor Dwayne Emil Dixon talks about his "Christian ethics" in assaulting fellow Americans he smears as KKK and Nazis. // INTERESTING CALLS — see below!  MUSIC: Ninety Pound Wuss – "Second Stage of Adolescence" and "At the End of It All" – from 1999 album Short Hand Operation (sic)  Also check out Hake News from today.  CALLERS Robert from Pasadena, CA felt bad learning American Indians died of our diseases.  Alex from CA agrees you can't solve an evil spirit with physical race changes.  Tony from NJ thinks it's nonsensical to say feeling sorry for people isn't love.  Paul from NC, 15, is concerned his high school wants him vaxxed and masked!  TIME STAMPS 0:00 Fri, Jul 23, 2021 1:29 Second Stage of Adolescence 4:36 Hey, guys! 6:09 America's Frontline Doctors 14:12 Marijuana for Vaxx? 16:06 GQ vs the Bible 23:08 Tease: Soft evil 23:38 Robert, Pasadena, CA 42:22 Alex, CA 45:48 More on Antifa Prof 56:38 Tony, NJ 1:02:00 Paul, NC 1:01:57 Thanks, all! 1:04:18 At the End of It All HAKE LINKS VIDEO ARCHIVE: Facebook | Periscope/Twitter | YouTube | Audio podcast links below PODCAST: Apple | Podcast Addict | Castbox | Stitcher | Spotify | Amazon | PodBean | Google  LIVE VIDEO: Trovo | DLive | Periscope | Facebook | Twitch* | YouTube*  SUPPORT: SubscribeStar | Patreon | Teespring | SUPER CHAT: Streamlabs | Trovo   Call in! 888-775-3773, live Monday through Friday 9 AM (Los Angeles) https://thehakereport.com/show  Also see Hake News from JLP's show today.  *NOTE: YouTube and Twitch have both censored James's content on their platforms lately, over fake "Community Guidelines" violations.  BLOG POST: https://www.thehakereport.com/blog/2021/7/23/072321-fri-vaxx-hype-gq-vs-the-bible-girly-antifa-prof-1-hour 

In this Special Edition, the Divas discuss the recent Food and Drug Administration's (FDA) July 6th announcement rescinding the Emergency Use Authorization (EUA) of KN95 respirators.  If you are still using KN95 respirators in your practice, don't miss this episode! Listen to the Divas explain the purpose of the EUA, what masks you should be using, and what this means for your practice as well as sharing best practices for remaining compliant and safe in your practice. 

The COVID-19 Vaccine has brought to the forefront an awareness of something called an Emergency Use Authorization (EUA). As a result, the questions swirl around what they are and what they mean to the safety of the vaccine and other therapies surrounding COVID-19. Listen in as we discuss this very important topic. Our guests today are: Dr Uma Sharma - Chief Scientific Officer - MMS Dr Sharma provides oversight for all clinical activities especially submissions and complex regulatory projects. As needed by their sponsors, she leads advisory committee meetings and participates in advisory boards for drug development, as well as product defense strategies especially for critical safety issues and label strategy discussions. With more than 24 years of experience in the pharmaceutical industry, she has been an invited speaker at several national and international events. Ben Kaspar, Senior Manager Regulatory Strategy Ben works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life-cycle. Ben and team have a deep experience in regulatory science for drug/biologic development, designing innovative strategies to maximize the likelihood of regulatory approval of the target across a variety of therapeutic areas including rare diseases. Here are some of the topics we cover today: What is the last book you read? What is an EUA and why are we hearing so much about them now? Does a EUA allow a drug to be used around the world during a pandemic? Is this just a thing for the US or some subset of countries? Are All COVID related approvals an automatic EUA? If we are able to get an EUA for something like COVID, why can't every unmet condition have an EUA? Certainly plenty of other conditions are even MORE serious to many people. Are EUAs easier than regular approvals? Public perception is that these are a short cut and all studies are not completed. I think the thing I hear about the most is the “long term studies”... Are EUAs here to stay after the pandemic? Will there be more EUAs than before? Have we broken through some imaginary barrier that will now allow us to do this more often? What do you think the industry can learn from this effort for future growth and streamlining discovery/testing efforts? Reach out to MMS Holdings... https://www.mmsholdings.com/ Dr. Sharma on LinkedIn - https://www.linkedin.com/in/umasharmaphd/ Ben Kaspar on LinkedIn - https://www.linkedin.com/in/benkaspar/ Reach out to me on LinkedIn https://www.linkedin.com/in/talktojesse/ or on my website at https://www.modernbiopharma.com/.

President Biden's Federal Land Grab  In this episode, guest host Harriet Hageman critiques President Biden's plan to put 30% of U.S. land area under federal control by 2030. On January 27, 2021, President Biden signed Executive Order 14008, Tackling the Climate Crisis at Home and Abroad. The Order sets forth the Biden administration's policies to address climate change. But the “30 by 30” plan within the Order is raising concerns for many farmers and ranchers nationwide.  The “30 by 30” plan is a scheme to put 30% of U.S. land area under federal control by 2030. According to the U.S. Geological Survey, right now, about 12-percent of the land in the U.S. is in conservation. Within the next 10 years, the federal government hopes to transition nearly 440 million acres into federal protection.To achieve the 30% conservation goal some agricultural land could be impacted, including privately-owned land. The question for landowners, is will they be forced to conserve their land? The Limits on Emergency Use Authorization Vaccines   Later in the episode, Mark explains the limits on Emergency Use Authorization vaccines and why mandating their use for everyone is not wise. Covid-19 vaccines have been approved only pursuant to an Emergency Use Authorization (EUA). In granting authorization for emergency use, the FDA concluded that the known benefits outweigh the known risks after a few months of clinical trials. The standard is much higher for medical products to receive full FDA approval. In order to obtain such approval, a vaccine must be rigorously tested and monitored for an extended time period. Crucially, the EUA statute mandates that potential recipients be informed of the risks and benefits and that they have the option to accept or refuse the treatment.  See omnystudio.com/listener for privacy information.

Jay Lalezari, MD is a physician and the Director of Quest Clinical Research who recently penned “Hope for Critically Ill Covid-19 Patients Within Reach” wherein he describes the results of a randomised, double-blind study of a drug called leronlimab (Vyrologix or PRO 140) which demonstrates a 82% reduction in the rate of death at Day 14 for patients on a ventilator who received 2 weekly doses of leronlimab compared to a placebo. Stressing the urgency for the FDA to approve leronlimab under an Emergency Use Authorization (EUA), Lalezari examines the various obstacles to achieving this end—from the ways in which Small Pharma faces greater economic hurdles compared to Big Pharma to the effort by short-sellers to sink CytoDyn, the producer of leronlimab, to the politics that allow Big Pharma to overpower smaller pharmaceutical companies strategically and economically. To confirm the finding for the FDA, CytoDyn must perform another trial of leronlimab that will take months to complete meanwhile critically ill patients in the Philippines are receiving leronlimab as part of the therapeutic treatment for critically ill COVID-19 patients and in Brazil some patients are well on the road to receiving this life-saving drug in Phase 3 trials soon to be conducted in up to 45 clinical sites. Get full access to Savage Minds at savageminds.substack.com/subscribe

In the global effort to address the COVID-19 pandemic, healthcare practitioners need to stay up to date as the Emergency Use Authorization (EUAs) for treatments and vaccines change rapidly. This 6-part podcast series opens with a discussion of how EUAs work and how they are different from full approval. In the subsequent episodes, experts explain the latest evidence-based information on inpatient and outpatient antiviral treatments, the most recent information on available vaccines, and how the emerging SARS-CoV-2 variants impact our COVID-19 toolbox. This activity is available for CE/CME credit.In this first of a 6-episode series on Emergency Use Authorization (EUA) in COVID-19, an expert explains the differences between EUA and full approval, how long EUAs last, and how new clinical trial evidence supports and changes an EUA. The discussion concludes with an overview of safety and management of potential adverse events. Claim your credit at pce.is/COV19.

In the global effort to address the COVID-19 pandemic, healthcare practitioners need to stay up to date as the Emergency Use Authorization (EUAs) for treatments and vaccines change rapidly. This 6-part podcast series opens with a discussion of how EUAs work and how they are different from full approval. In the subsequent episodes, experts explain the latest evidence-based information on inpatient and outpatient antiviral treatments, the most recent information on available vaccines, and how the emerging SARS-CoV-2 variants impact our COVID-19 toolbox.This episode provides an overview of the rapid development of vaccines currently under Emergency Use Authorization (EUA) for the prevention of SARS-CoV-2 in the United States. An expert describes the mechanisms of action for the mRNA and viral vector vaccines, as well as efficacy, side effects, and post-vaccine safety assessment. The conversation concludes with a review of what is needed to achieve herd immunity, and guidance for people who are fully vaccinated. Claim your credit at pce.is/COV19.

In the global effort to address the COVID-19 pandemic, healthcare practitioners need to stay up to date as the Emergency Use Authorization (EUAs) for treatments and vaccines change rapidly. This 6-part podcast series opens with a discussion of how EUAs work and how they are different from full approval. In the subsequent episodes, experts explain the latest evidence-based information on inpatient and outpatient antiviral treatments, the most recent information on available vaccines, and how the emerging SARS-CoV-2 variants impact our COVID-19 toolbox.In this fourth episode of the 6-part series, an expert explains what COVID-19 treatments are available in the outpatient setting. The focus is on monoclonal antibodies, bamlanivimab + etesevimab and casirivimab + imdevimab. For both drug combinations, he discusses the Emergency Use Authorization (EUA) indications, evidence on efficacy, and potential toxicities. Claim your credit at pce.is/COV19.

In this episode, Nelson Perez talks about the updated immunization requirements Rutgers University has implemented for the Fall 2021 semester.  The news comes when anti-vaxxers and vaccine skeptics are at an all-time high in countries like the United States and Brazil. From explaining how the Food and Drug Administration implements Emergency Use Authorization (EUA) to learning about the historical context of how lawsuits against vaccines were established and how anti-vaxxers have exploited the National Vaccine Injury Compensation Program of 1988 (VICP).  Does Rutgers University care about their student's health and safety, or is this the beginning stages of the depopulation plan known as - Agenda 21? https://www.facebook.com/TheSocialChemistFBOur Path Forward – COVID-19 Vaccination and the Fall Term | Rutgers UniversityImmunization Requirements & Allergy Shots – Student Health (rutgers.edu)Vaccine Basics (cdc.gov)Emergency Use Authorization for Vaccines Explained | FDAVaccination Is the Best Protection Against Measles | FDAEstimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States — 2018–2019 influenza season | CDCWhat You Need to Know About Dietary Supplements | FDACoronavirus in the U.S.: Latest Map and Case Count - The New York Times (nytimes.com)Brazil Coronavirus Map and Case Count - The New York Times (nytimes.com)

The Coronavirus pandemic has put a spotlight on drug supply and the approval process of new medications. In this episode, we will discuss what frontline pharmacists need to know to about the drug approval process.    Guest speaker: Amanda Melton, PharmD, BCPS Senior Clinical Manager Center for Pharmacy Practice Excellence Vizient   Moderator: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence   Show Notes: [01:20] Patients accessing drugs through clinical trials [02:29] Pharmacists should familiarize themselves with the inclusion and exclusion criteria of clinical trials in order to help clinicians identify good patients candidates [03:00] ClinicalTrials.gov [3:17] Patients that don't qualify for a clinical trial can apply for access through an Expanded Access Program (EAP)   [3:35] What Pharmacists need to know about Expanded Access Programs (EAPs) [4:26] Goal of the EAP is to get the drug to the patient [5:03] Step by step process for accessing a drug under the Expanded Access Program (EAP) [5:42] Investigational New Drug (IND) application [6:30] Four stakeholders: manufacturer, FDA, patient and Institutional Revenue Board (IRB) [6:50] Getting access to the FDA by using Form 3926 [7:54] Timing for submitting an EAP [9:00] How Emergency Use Authorizations (EUAs) differ from Expanded Access Programs (EAPs)  [10:00] How long an EUA lasts [10:41] When an Emergency Use Authorization (EUA) is issued, it does not mean the drug is approved [11:15] Why apply for an EUA, instead of a biologics license [12:07] Issuance of an EUA for a product doesn't preclude the manufacturer from seeing approval for the product   Links | Resources: FDA: Emergency Use Authorization Click here FDA: Expanded Access Click here NIH U.S. Library of Medicine: ClinicalTrials.gov Click here Reagan-Udall Foundation for the FDA: COVID-19 Hub Click here   Subscribe Today! Apple Podcasts Google Podcasts Spotify Stitcher Android RSS Feed  

Thank you for joining us for the first episode of COVID Conversations! This series is a special presentation of OccPod, the official podcast of the American College of Occupational and Environmental Medicine. ACOEM is dedicated to sharing the latest COVID-19 news, and host conversations grounded in science with a focus on OEM, or occupational and environmental medicine. In this episode, which was recorded in December 2020, Erin Ransford and Dr. Ismail Nabeel, MD, MPH, MS, FACOEM discuss the COVID-19 vaccine and all it encompasses, including exploring novel pathways, clinical trials, Emergency Use Authorization (EUA,) distribution, and efficacy. Produced and recorded in tandem with ACOEM's COVID-19 Q&A Forum, these recordings aim to educate a general audience on SARS CoV2 and COVID-19. Be sure to check back soon for a new episode! About Dr. Nabeel: Dr. Nabeel is the Deputy Medical Director of Employee Health, Safety and Wellness for the Mount Sinai Health System, specializing in the prevention, diagnosis, and treatment of work-related injuries and illnesses. He is an Associate Professor in the Department of Environmental Medicine and Public Health at the Icahn School of Medicine at Mount Sinai. Dr. Nabeel is board certified in Internal Medicine, Preventive Medicine (Occupational Medicine) and Clinical Informatics. A Fellow of the American College of Occupational and Environmental Medicine, Dr. Nabeel currently serves as the Vice Chair of ACOEM's Council on Scientific Affairs.

The U.S Food And Drug Administration (FDA) clinical trial phases for New Drugs and Vaccines, as well as the Emergency Use Authorization (EUA) for Pfizer-BioNTech and for Moderna vaccines are explained in this video. This is for educational purposes only. Show Contact Info  Our Social Media (IG): @laverdadduelepod Subscribe to our YouTube: La Verdad Duele Podcast Join Our Listserv: LVD Podcast Listserv

Arnold S. Monto, MD, chaired the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings in December that led to Emergency Use Authorization (EUA) of the Pfizer/BioNTech and Moderna vaccines. He joins JAMA's Q&A series from the University of Michigan School of Public Health to discuss experience to date with the 2 products and what's next in vaccine development. Recorded January 11, 2021. Related Article(s): Experts Discuss COVID-19: Vaccine Allocation, Placebo Groups, and More

The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA). For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet. WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE PFIZER-BIONTECH COVID-19 VACCINE? Tell the vaccination provider about all of your medical conditions, including if you:• have any allergies have a fever have a bleeding disorder or are on a blood thinner are immunocompromised or are on a medicine that affects your immune system are pregnant or plan to become pregnant are breastfeeding have received another COVID-19 vaccine WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE? FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older. WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE? You should not get the Pfizer-BioNTech COVID-19 Vaccine if you: • had a severe allergic reaction after a previous dose of this vaccine • had a severe allergic reaction to any ingredient of this vaccine. WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE? The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose. HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN? The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the muscle. The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series. Reference: https://www.fda.gov/media/144414/download --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/thehealthflo/message

Hi, I am Marmee Regine, your host in Pandemic Podcast Coronavirus. Merry Christmas to everyone. Today is the 9th episode where we will discuss part two of my podcast on the recent Presidential election in the USA during the coronavirus pandemic. In my past podcast episode, I mentioned Operation Warp Speed by President Donald Trump. Since the election, there has been foreign interference in our U.S. voting system by the so-called Dominion software manipulated outside the USA. There have been tons of hardcore video evidence showing this is a rigged election. Still, as usual, the media denies their existence despite several cases have reached the Supreme Court. To balance this episode with the first part, I will discuss more about the vaccine. Covid-19 vaccine information COVID-19 vaccine distribution began on December 14, 2020 Monday. It is the vaccine by Pfizer Inc and German partner BioNTech. In the Phase 3 study's first objective, the efficacy rate of 95% was exhibited among the tested subjects having no prior SARS-CoV-2 infection. The second objective revealed the same percentage to subjects who have no previous and with prior SARS-CoV-2 disease. Both cases were measured seven days after the second dose. The efficacy demonstrated consistency on variables such as age, gender, race, and ethnicity. Plus, all participants in the trial will be continuously monitored to estimate the period of safety and protection in a span of two years after their second dose. There was an estimate of 44,000 trial volunteers who committed to the Pfizer and BioNTech study. In return, both companies pledge always to prioritize their safety. The study participants ought to be commended for their courage to help in this pandemic time by using their physical bodies and immune system to advance this scientific breakthrough with regards to this E.U. authorization on COVID-19 vaccine where they are granted marketing authorization on a conditional level, emergency cases temporary approval from more than 40 countries. In the coming weeks, there are continuous regulatory reviews for further permissions in several countries.About the Phase 3 Clinical Trial The Phase 3 clinical trial on BioNTech's proprietary mRNA technology, where the participants received their second dose, is in the ratio of 1:1 vaccine subjects to immune response, placebo effect, efficacy data for regulatory review. The study design is a randomized, observer-blinded study. The study will continue towards the prevention of infection by SARS-CoV-2, the virus that causes COVID-19. Study data will verify the duration of protection, increased safety time, and efficacy against asymptomatic SARS-CoV-2 infection. Furthermore, it will continue to investigate the immunogenicity and safety in adolescents 12 to 17 years of age. Additional studies include evaluating pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised. Authorization of vaccination in the USA The Pfizer-BioNTech COVID-19 Vaccine is authorized for an Emergency Use Authorization (EUA) to be used for active immunization for the purpose to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.  In Newark, New Jersey university hospital, emergency room nurse Maritza Beniquez received the vaccination last December 15, 2020 Tuesday. Maritza Beniquez was the first person in New Jersey to have the Covid-19 vaccine for media reporting. In her words, Beniquez stated, "I couldn't wait for this moment to hit New Jersey. I couldn't wait for it to hit the U.S.". Also, she received the vaccination with Governor Phil Murphy. So, the order of priority will be given to front-liners such as doctors, nurses, other front-line medical professionals, and essential workers. This also includes the residents and staff of nursing homes. Next in line will be senior citizens

Are you prepared for the aftermath of the pandemic's impact on the medical device industry? It may be time for device professionals to start bracing for a new normal. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device industry and how companies can prepare for and embrace the new medical device landscape that's expected to take shape from 2021 onward. Steven, a former FDA deputy associate commissioner and COO for the agency's Office of Regulatory Affairs currently serves alongside Eric as the Quality Systems and Compliance lead consultants in the FDA and Life Sciences practice of their law firm. With more than 50 years of combined industry experience between Steven and Eric, the insights and knowledge of this episode's guests, specifically as it relates to this topic is a MUST listen for any medical device professional. Some of the highlights of the show include: Steven and Eric discuss how COVID is pushing the FDA toward a voluntary pilot program for agency investigators to conduct virtual facility inspections. Steven describes the current state of FDA inspections as challenging to work remotely and conduct follow-ups when appropriate. The FDA has established a paradigm to continue on-site mission critical inspections. Eric expands on the logistical challenge for inspections by explaining that since the FDA has put a hiatus on its inspection scheme, many organizations are following the Medical Device Single Audit Program (MDSAP). The Medical Device Coordination Group's (MDCG) 2020-4 Guidance lists four circumstances where organizations under MDSAP or EU notified bodies have remote audits—surveillance, re-certification, change notification, and termination. Impact of the Emergency Use Authorization (EUA) program and the influx of requests on FDA. Some EUA submissions require pre-approval inspections. Before EUAs are revoked, build a remediated QMS, prepare for inspection, and decide whether to continue manufacturing a product after the pandemic. King & Spalding's FDA and Life Sciences team offers a full-service approach, including cardiologists to help with health assessment risks, premarket and postmarket mergers and acquisitions, and warning letters. Pre-submission is an initial but formal way to build communication, collaboration with the FDA. A pre-submission can be an effective means for understanding regulatory requirements.

There is no FDA-approved vaccine yet to prevent COVID-19. Still in Clinical Trials, However, the FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 and Moderna Vaccines to prevent COVID-19 under an Emergency Use Authorization (EUA). The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone... FOR MORE INFORMATION PLEASE CONTACT: CDC https://www.cdc.gov/coronavirus/2019 Visit FDA at https://www.fda.gov/emergency-prepare regulatory-and-policy-framework/emergency-use-authorization. All Sisters Halaqa Association (ASHA ) is one of the Programs of Women's Health First, a Nonprofit Organization with the mission of strengthening communities by promoting the health and wellbeing of women through public health education and promotion. ASHA is committed to developing Islamic Education and activities unique to Women and their families, based on Quran And Sunnah, Hadith, via What's App and ZOOM. SISTERS HALAQA IS ABOUT SEEKING ISLAMIC KNOWLEDGE UNIQUE TO WOMEN (Menses, Hijab, Nutrition, Family Planning, Mariage, Divorce, Rights, and Duties, Islam and Public Health, Rabbana Duas and More. ..) FOR THE PLEASURE OF ALLAH SWT. www.allsistershalaqa.org Please contact us at info@allsistershalaqa.org info@womenshealthfirst.org --- Support this podcast: https://anchor.fm/allsistershalaqa/support

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19. The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA). The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. Just 2 days ago On December 18, the U.S. Food and Drug Administration, approved Moderna Vaccine for emergency use as well... FOR MORE INFORMATION PLEASE CONTACT: CDC https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.htmlVisit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcmlegal- regulatory-and-policy-framework/emergency-use-authorization. All Sisters Halaqa Association (ASHA ) is one of the Programs of Women's Health First, a Nonprofit Organization with the mission of strengthening communities by promoting the health and wellbeing of women through public health education and promotion. ASHA is committed to developing Islamic Education and activities unique to Women and their families, based on Quran And Sunnah, Hadith, via What's App and ZOOM. SISTERS HALAQA IS ABOUT SEEKING ISLAMIC KNOWLEDGE UNIQUE TO WOMEN (Menses, Hijab, Nutrition, Family Planning, Mariage, Divorce, Rights, and Duties, Islam and Public Health, Rabbana Duas and More. ..) FOR THE PLEASURE OF ALLAH SWT. www.allsistershalaqa.org Please contact us at info@allsistershalaqa.org info@womenshealthfirst.org --- Support this podcast: https://anchor.fm/allsistershalaqa/support

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader who has been coined the name “Mr. Regulatory.” Listen to this episode as Mr. Regulatory shares his predictions on potential policy changes or updates we may begin to see from FDA, as influenced by the Emergency Use Authorization (EUA) response to address the current health crisis caused by the COVID-19 pandemic.

With the Pfizer and Moderna coronavirus vaccines reportedly under review at the US FDA for Emergency Use Authorization (EUA), Paul A. Offit, MD, of the Children's Hospital of Philadelphia, returns to JAMA's Q&A series to provide an update on what to expect, prospects for vaccine rollout and distribution in the coming months, and ongoing safety surveillance. Recorded December 2, 2020. Related Article: Developing a SARS-CoV-2 Vaccine at Warp Speed

In this news podcast, I look at the success and progress of the Pfizer and Moderna vaccines and their situation concerning receiving and Emergency Use Authorization (EUA). Today, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) met to determine recommendations on the distribution of the vaccines, I take a look at what they came up with. I also look at some recent polls concerning what percentage of Americans would take the new vaccines--a very important factor for us to achieve some semblance of herd immunity.

Pfizer and BioNtech have filed for Emergency Use Authorization (EUA) for their COVID-19 vaccine. In this episode of CareTalk, John Driscoll (CareCentrix) and David Williams (Health Business Group) discuss how the vaccine will be distributed, how effective the vaccines are projected to be and the question that's on everyone's mind: "when can I get it?!" Subscribe to CareTalk on your favorite podcast service:Spotify https://open.spotify.com/show/2GTYhbN...Apple Podcasts https://podcasts.apple.com/us/podcast...Google Podcasts https://podcasts.google.com/feed/aHR0...Watch this episode on YouTube: https://youtu.be/5DBsd2AYPiw

Pemerintah berencana melakukan vaksinasi Covid-19 pada minggu ketiga bulan Desember tahun ini. Kandidat vaksin Covid-19 yang bakal digunakan pemerintah adalah Sinovac, vaksin yang diimpor dari China. Pemerintah menyatakan, saat ini mereka tengah melakukan uji klinis fase ketiga terhadap vaksin tersebut. Awalnya, pemerintah berencana melakukan vaksinasi pada bulan November 2020. Namun rencana itu diundur. Pemerintah beralasan, Badan Pengawas Obat dan Makanan (BPOM) memerlukan waktu untuk menerbitkan Emergency Use Authorization (EUA). Hal ini penting guna menjamin keamanan vaksin yang akan digunakan. Bagaimana kesiapan pemerintah terkait rencana vaksinasi Covid-19? Apakah ada kemungkinan diundur lagi? Vaksin mana yang akan digunakan? Berapa orang yang ditargetkan akan divaksinasi dan sampai kapan? Apa benar vaksin tak mampu menangkal penyebaran dan penularan virus corona? Jika iya, apa yang mesti dilakukan pemerintah guna mengendalikan pandemi? NARASUMBER: • Dr ADIB KHUMAIDI SpOT – KETUA TIM MITIGASI PB IDI & KETUA TERPILIH PB IDI • BAMBANG HERIYANTO – CORPORATE SECRETARY BIO FARMA • Dr. BRIAN SRI PRAHASTUTI - TENAGA AHLI UTAMA KSP • PROF. KUSNANDI RUSMIL - KETUA TIM RISET UJI KLINIS VAKSIN COVID-19 UNPAD #Jokowi #vaksin #pandemi #corona #dokter #jakarta #indonesia

Hydroxychloroquine and convalescent plasma approvals by the FDA under Emergency Use Authorization (EUA) protocols have raised concerns the agency is under withering political pressure to fast-track a COVID-19 vaccine before it is proven safe and effective. Joshua Sharfstein, MD, Johns Hopkins Bloomberg School of Public Health, and JAMA Associate Editor Preeti Malani, MD, University of Michigan, discuss implications for public health and policy responses to ensure vaccine safety. Recorded September 18, 2020. Related Article: Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine

Recently, Remdesivir was given Emergency Use Authorization (EUA) status by the U.S. Food and Drug Administration (FDA) for use in COVID based on a heretofore unpublished study. The study, conducted by NIAID,  is the subject of this episode.This episode is accredited for CPE.  For CE details and to claim credit click here:  https://bit.ly/3hn191p See omnystudio.com/listener for privacy information.

Recently, Remdesivir was given Emergency Use Authorization (EUA) status by the U.S. Food and Drug Administration (FDA) for use in COVID based on a heretofore unpublished study. The study, conducted by NIAID,  is the subject of this episode. This episode is accredited for CPE.  For CE details and to claim credit click here:  https://bit.ly/3hn191p  See omnystudio.com/listener for privacy information.

This is the audio-only version of DEVICE LOVE Live! #2, originally recorded April 24th, 2020. In response to the COVID-19 global pandemic, health authorities are taking the necessary steps to allow for greater access to and use of critical medical devices and PPE that are in short supply. However,some manufactures lack the necessary regulatory approvals needed to make their medical devices/PPE available. In situations such as these, both the United States (FDA) and European Union (European Commission) have legislation in place to help bring these critical products to patients and healthcare workers for emergency applications. In the United States, the US FDA has invoked the Emergency Use Authorization (EUA) authorizing the use of an unapproved product or an unapproved use of an approved product, provided that other statutory criteria are met. In the European Union, Article 59 of the EU MDR (2017/745) can be used where the European Commission is responsible for identifying and authorizing certain medical devices and PPE that may be sold without CE Marking during the public health emergency and market access is granted individually by the Competent Authority of each member state. The EU has already issued an implementing act restricting export of PPE from the EU and recommended conformity assessment procedures within the context of COVID-19 threat, including extraordinary measures related to notified body audits. In this show, we'll discuss both emergency applications and talk with experts on: The overall process and requirements What products this regulatory route can be used for Explain the “shortcuts” this provides What these processes are NOT intended for And more! Does your organization have a product that could utilize these pathways? Do you have questions on how to get this done quickly and effectively? Panelists: Ibim Tariah, Ph.D. — Vice President of EU MDR and IVDR Consulting Services, R&Q (former BSI) Nancy Morrison, RAC — Executive Director of Regulatory and Quality Consulting Services, R&Q Niki Spaniel — Senior Principal Specialist, R&Q Kevin Go — Senior Engineer, R&Q (former FDA) Moderator: Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com. The and means more. --- Send in a voice message: https://anchor.fm/devicelove/message