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 […]
Vaccines
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 […]
Documents Reveal Lipid Nanoparticles in Pfizer Vaccine Travel From Injection Site, J&J Virus Particles Present Months After Jab
Judicial Watch announced Tuesday it received 466 pages of records from the Department of Health and Human Services (HHS) containing biodistribution studies and related data for COVID-19 vaccines that show lipid nanoparticles (LNPs) contained in Pfizer’s COVID-19 vaccine travel outside the injection site and settle primarily in the liver, adrenal glands, spleen and ovaries of test […]
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 […]