After rollout under emergency authorization, manufacturers of COVID vaccines now have their sights on regulatory approval – but should we rush approval based on only six months’ worth of data from unblinded trials?
In April 2021, Pfizer and Moderna announced efficacy results at the six-month mark from the phase 3 trials of their respective COVID-19 vaccines. Pfizer CEO Albert Bourla said the company’s data “confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA [Food and Drug Administration].” And on May 7 it formally initiated that application which, if successful, will earn the Pfizer-BioNTech product, BNT162b2, the distinction of becoming the first COVID-19 vaccine approved by the FDA. Because lest we forget, all COVID-19 vaccines currently in use in the U.S. are available under emergency access only.
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