FDA grants full approval to Pfizer COVID-19 vaccine

The FDA has granted full approval of the Pfizer COVID-19 vaccine, making it the first COVID vaccine to transition from an emergency authorization to full approval.

The Food and Drug Administration on Monday granted full approval of the Pfizer COVID-19 vaccine, becoming the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval. The approval comes in a week prior to federal health officials' earlier estimates that the agency would complete its review by Labor Day. The full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial. “Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Albert Bourla, Pfizer CEO said in a statement to ABC. "Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans.”