Pfizer Booster for More Teens Moves Closer to FDA Clearance
(Bloomberg) -- Food and Drug Administration authorization of Pfizer Inc. booster vaccines for more teens took a step forward when the agency said further study by an advisory committee wasn’t necessary.
Third doses for those age 16 and 17 do “not raise questions that would benefit from additional discussion by the members of the committee,” the FDA said in an email.
The development on Wednesday signals the FDA has no particular safety concerns for the age bracket.
Last month the FDA authorized booster doses for those 18 and older. Pfizer subsequently asked the U.S. to allow booster shots for younger teens, a move that would expand access to additional doses amid worry about the new omicron variant.
A spokesperson said that while the FDA “cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible.”
Children age 5 and older in the U.S. have been able to receive the messenger RNA vaccine. Boosters have been cleared only for adults.
President Joe Biden this month called on health providers to expand the availability of coronavirus vaccines and booster shots in a bid to hold off the omicron variant and combat a winter surge of infections.
©2021 Bloomberg L.P.