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In Rush For Regulatory Approval Of Covid Vaccines, Do We Need More Data? by Peter Doshi

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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