Today, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
This news is met by perhaps a majority with enthusiasm, even elation. However, a growing call for transparency and assurance that the science is correct cannot be ignored by TrialSite. Peter Doshi, senior editor for the prestigious medical journal The BMJ is one of those concerned. Today, he outlined several concerning elements about this unprecedented, accelerated approval in an opinion piece. One where data from a new vaccine under investigation isn’t yet complete for another couple of years.
Doshi, part of the Coalition Advocating for Adequately Licensed Medicines (CAALM), has formally petitioned the FDA to halt COVID-19 vaccine approvals this year.
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