The Food and Drug Administration on Wednesday authorized updated versions of Pfizer-BioNTech’s and Moderna’s Covid booster shots that target the highly contagious BA.5 omicron subvariant.
The FDA authorized Pfizer’s modified booster for people ages 12 and older; Moderna’s shot was authorized for those 18 and up.
People who’ve received the two-dose primary series of either vaccine and those who’ve received the initial two doses plus one or two boosters are eligible for the updated shots as long as two months have passed since their last shot, the agency said in a statement.
The FDA’s signoff isn’t the last step: The decision will now go to the Centers for Disease Control and Prevention and its advisory committee to issue their own recommendation on how the shots should be used. The agency’s Advisory Committee on Immunization Practices is scheduled to vote Thursday. CDC Director Dr. Rochelle Walensky could sign off on the doses shortly after Thursday’s meeting, and vaccinations could begin widely after Labor Day.
Dr. Peter Marks, the FDA’s top vaccine regulator, said on a call with reporters on Wednesday that health officials expect the updated boosters will provide increased protection against the BA.5 omicron subvariant.
BA.5 makes up nearly 90% of all new Covid cases in the United States, according to the CDC.
“A great deal of care has been taken by the FDA to ensure that these updated boosters meet our rigorous safety, effective and manufacturing quality standards for emergency use authorization,” he said on the call.
The agency’s two-month gap recommendation for receiving the updated shots is meant in part to ensure that there’s enough time for the shots to build a good immune response, Marks said.
He also said that gap should reduce the risk of a rare heart inflammation condition called myocarditis. Both Pfizer’s and Moderna’s first iteration of the Covid vaccines have been linked to a small but increased risk of the heart condition, particularly in young men. Marks said a wider gap between doses appears to reduce the risk of the condition.