An 80,000-page cache of Pfizer-BioNTech COVID-19 vaccine documents released by the U.S. Food and Drug Administration (FDA) sheds light on Pfizer’s extensive vaccine trials in Argentina, including the unusually large size of the trials and the story of a trial participant whose vaccine reaction was “disappeared.” The case of Augusto Roux in Argentina suggests that in at least one instance, […]
COVID Vaccines
FDA Chooses Pfizer Over Kids, Signs Off on Boosters for Children 5 to 11 and Bypasses Advisory Panel
The U.S. Food and Drug Administration (FDA) today authorized a booster dose of the Pfizer-BioNTech COVID vaccine for children ages 5 to 11, without convening its vaccine advisory panel of independent experts to discuss Pfizer’s data on 5- to 11-year-olds — and based on a study subset of only 67 children. The children were only […]
FDA Can Authorize COVID Vaccines for Kids Under 6 Despite Failure to Meet 50% Efficacy Requirement, Top Official Says
The U.S. Food and Drug Administration’s (FDA) top vaccine official told a congressional committee on Friday that COVID-19 vaccines for kids under six will not have to meet the agency’s minimum 50% efficacy threshold required to obtain Emergency Use Authorization (EUA). The FDA is currently reviewing data from Moderna’s two-shot vaccine for infants and toddlers […]
Was Pfizer’s 95% Vaccine Efficacy Claim Fraudulent From the Start? Data Show ‘Staggeringly Low’ 12%
Buried within the FDA’s briefing document for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 10, 2020, for the Pfizer-BioNTech COVID-19 Vaccine — there is alarming data and a concerning issue that should be addressed. Firstly, it’s worth pointing out that Pfizer used a ‘central laboratory’ (see page 13 of the document) of […]
FDA Limits J&J Shot Over ‘Potentially Life-Threatening’ Blood Clotting Disorder, Ignores Thousands of Reports to VAERS
In another setback for Johnson & Johnson’s (J&J) COVID vaccine, the FDA on Thursday placed strict limits on the use of the one-dose shot, citing concerns over a “rare and potentially life-threatening” blood clotting disorder. The FDA said the shot should only be given to adults who cannot receive an mRNA vaccine or specifically request […]