FDA issues first COVID-19 vaccine EUA for Pfizer-BioNTech with no data on “preventing transmission”

On December 11, 2020, the US Food and Drug Administration (FDA) granted the first Emergency Use Authorisation (EUA) for a brand new technology product, the Pfizer-BioNTech COVID-19 mRNA vaccine, just 9 months after phase I trials began, and after only 108 days of regulatory safety review. In their press release they stated: "The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA".  The FDA stated the vaccine "may be effective in preventing COVID-19", then state it is 95% effective in "preventing" COVID-19, that 95% is based on "a 2 month study of a couple hundred people.  That's it!". [3] The day before, on December 10, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to assess the Pfizer-BioNTech COVID-19 Vaccine and prepare a Briefing Document for the FDA. [6] The FDA stated "[t]he vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group."  8 plus 162 equals 170 trial participants was all that were used to determined the relative risk of "95% effective", where as the absolute risk (of all 36,523 trial participants)..> READ MORE

US: Saline Placebo Control Group is demanded for COVID-19 vaccine clinical trials

On June 17, 2020 Aaron Siri's law firm on behalf of ICAN sent a Citizen Petition to the FDA demanding "that all Phase II and III COVID-19 vaccine trials include a placebo control group, that the placebo should be a saline injection without anything added, and that the placebo control group be at least equivalent in size to the experimental group". [1] Two days later on June 19, 2020 the FDA updated their “development and licensure” Guidelines for Industry The petition also requested: "All systemic adverse reactions, adverse events, serious adverse events, medically-attended adverse events, new onset medical conditions, and any other health issue arising or exacerbated post-vaccination shall be documented for each subject post-vaccination for a period of at least twelve months for adults, thirty-six months for children and teenagers, and sixty months for infants and toddlers." The FDA failed this as the placebo arm was unblined on Dec 14, 2020 for Pfizer/BioNTech  and January 14, 2021 for Moderna so no long term safety signals will ever be determined "causative". [1]
Dr Bret Weinstein PhD
Posted inCredentialed Experts

Dr Bret Weinstein

Dr Bret Weinstein PhD is an Evolutionary Biologist, author and host of the DarkHorse Podcast with his wife Heather Heying who is also a Biologist. He served as a professor of biology at Evergreen State College, but resigned in the…
15 September 2024Posted inCredentialed Experts

FDA announces EUA for “2024-2025 Formula” of mRNA COVID-19 vaccines!

On August 22, 2024 the FDA announced the approval plus EUA of the 2024-2025 formula of the Pfizer and Moderna mRNA COVID-19 vaccines, that "include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2".  Novavax did not get an approval. [1, 2, 3] New York Times reports many Americans, elderly and nursing home included, are NOT taking the booster shots, only 1/3 of nursing home residents are considered "up to date". “Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Report: Biden Adminstration found to pressure FDA into licensing mRNA vaccine

On June 24, 2024 the US House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust, led by Chairman Thomas Massie released a report detailing "how the Biden Administration pressured the Food and Drug Administration (FDA) to go beyond its regulatory authority to change its procedures, cut corners, and lower agency standards to approve the Pfizer COVID-19 vaccine and authorize boosters" [1, 2] "During the pandemic, politics overruled science at the government institutions entrusted with protecting public health. The FDA abandoned its congressional directive to protect citizens from false claims and undisclosed side effects, and instead ignored its own rules to pursue a policy of promoting the vaccine while downplaying potential harms." [1] The FDA "cut corners in its usually rigorous BLA process to brand the Pfizer EUA vaccine as the only fully licensed "safe and effective" COVID-19 vaccine on the market at the time"

NIAID launch the COVID-19 Prevention Trials Network (COVPN)

On July 8, 2020 the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) launched a new clinical trials network to enrol volunteers for large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19. Called the COVID-19 Prevention Trials Network (COVPN) it was the merging of 4 existing NIAID-funded clinical trials networks - 3 for AIDS plus the Infectious Diseases Clinical Research Consortium (IDCRC). Within a few weeks they were conducting clincal trial for Moderna's vaccine. The NIAID stated that vaccine generated antibodies will be "different" to antibodies generated from natuaral infection with SARS-CoV-2!!  Antibody tests approved were only those that detected the nucleocapsid, if they targeted "spike antigens" then the immunized person would return a positive result! In 2020 COVPN were conducting clinical trials for: Moderna’s mRNA-1273 vaccine, The COVE Study™ Regeneron’s 10933 and 10987 Antibodies, the REGN-COV2 Study Eli Lilly’s LY3819253 Antibody, the BLAZE-2 Study Pfizer & BioNTech’s BNT162b2 COVID-19 mRNA investigational vaccine The ENSEMBLE Study with Janssen’s Ad26.COV2.S Investigational Vaccine AstraZeneca Investigational COVID-19 vaccines AZD1222

Gates Foundation Dumps mRNA Shares in Q3 of 2021 at Huge Profit

By November 15, 2021 the Bill & Melinda Gates Foundation (BMGF) had sold off 86% of their share holding in BioNTech at massive, untaxable profit. The foundation purchased the shares in September 2019. [1, 2, 3] In November of 2021, Bill Gates, after dumping his stocks, "shockingly declared that “we need a new way of doing the vaccines.”...“We didn’t have vaccines that block transmission,” Gates said, contradicting all of his previous interviews in which he continuously claimed the shots were safe and significantly block transmission." [1]
Gene Therapy
Posted inPublic Health Vaccines

Gene Therapy

The definition of "Gene Therapy" appears to mean different things to different bodies. This page is an attempt to log definitions and understand the evolution of "gene therapy" from the context of how designated "gene therapy" products (i.e. Moderna and…
18 April 2024Posted inPublic Health, Vaccines