Will FDA Allow Pfizer, Moderna to Skip Clinical Trials for Future COVID Vaccines?

Toby Rogers Pfizer and Moderna have a problem — their COVID-19 shots do NOT work. Everyone knows this. The shots do not stop infection, transmission, hospitalization, or death. … So Pfizer and Moderna have figured out a way to use regulatory capture to get their reformulated COVID-19 shots approved WITHOUT further clinical trials. Their scheme […]

There Is No Basis for the FDA to Authorize Covid Vaccines For Toddlers

Ian Miller In a historically embarrassing decision, the FDA recently became the only international regulatory body to authorize the use of mRNA vaccines from Moderna and Pfizer for children aged six months to five years. For the overwhelming majority of young children and toddlers, there is likely no justification or need for this concerning authorization. […]

What FDA Advisors Got Wrong About COVID Vaccines for Young Kids

two babies on porch

James Lyons-Weiler What members of the U.S. Food and Drug Administration’s vaccine advisory committee saw and heard during Wednesday’s meeting should have stopped them from recommending authorization of COVID-19 vaccines for children as young as 6 months — but it didn’t.

FDA Unanimously Approve Covid Vaccine for 0-4 Years: Unfathomable Decision Given the Trial Data

grayscale photo of girl in polka dot long sleeve shirt

Health Advisory & Recovery Team (HART) It was depressing that in the FDA open meeting, none of the members pointed out that 2 months follow-up is totally inadequate for assessing safety, nor questioned the use of an antibody level as a measure of success.  … Moderna was also authorised for children at the same meeting, despite several countries having dropped it […]