NEW YORK — Pfizer introduced U.S. regulators have agreed to a “precedence overview” of whether or not its COVID-19 vaccine needs to be absolutely accredited, with a choice set for no later than January.
Greater than 186 million doses of the vaccine made by Pfizer and its German accomplice BioNTech have been administered within the U.S. alone since December. Many extra doses have gone to different international locations which have approved emergency use of the vaccine through the pandemic.
Vaccines cleared for emergency use nonetheless should bear the stringent full approval course of, a step that may assist persuade some individuals who aren’t but immunized to roll up their sleeves.
The Meals and Drug Administration’s January deadline is a formality. The choice might come far sooner given how carefully the company has been monitoring the vaccine’s widespread use.
Pfizer’s software, submitted in late Might, contains the newest information from a big research that tracked contributors 16 and older for six months after their second dose. The vaccine is given to individuals as younger as 12, and Pfizer additionally intends to submit information wanted for full approval in that age group.