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
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 […]
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 […]
Pfizer’s ‘Fully Approved’ Comirnaty Vaccine is Still Not Available in the U.S.
On August 23, 2021, the US Food and Drug Administration (FDA) approved Pfizer’s biological licensing application (BLA) for its COVID-19 vaccine named COMIRNATY for people aged 16yrs and older. At the time, vaccine hesitancy was persistent and the acting FDA Commissioner Janet Woodcock said that granting full approval to the vaccine might “instill additional confidence” in people to get […]
Pfizer Secretly Hired 600+ Employees to Process Flood of COVID Vaccine Adverse Events
An unredacted document obtained through a Freedom of Information Act (FOIA) request showed Pfizer had to unexpectedly hire 600 additional full-time employees to process a flood of adverse events reported during the three months following emergency use authorization of its COVID vaccine. According to the newly released documents, Pfizer planned to hire more than 1,800 […]