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FDA clears the way for additional bivalent boosters for certain vulnerable individuals

by Brenda Goodman, CNN

Published 11:09 AM EDT, Tue April 18, 2023

The U.S. Food and Drug Administration amended the terms of its emergency use authorizations for the Pfizer and Moderna bivalent vaccines on Tuesday, allowing people ages 65 and older and certain people with weakened immunity to get additional doses before this fall’s vaccination campaigns.

The bivalent vaccines made by Pfizer and Moderna carry instructions for fighting both the original strain of the Covid-19 virus as well as Omicron and its spinoffs.

They have been available in the United States since September under emergency use authorizations, or EUAs, which tightly restrict how the vaccines may be given.

On Tuesday, the FDA changed the terms of the authorizations for those vaccines so that certain individuals could get an additional dose ahead of most others.

Namely, adults ages 65 and older who have received a single dose of a bivalent vaccine may receive an additional dose at least four months following their first dose.

Most individuals with certain degrees of immunocompromise who have received a first dose of a bivalent vaccine can get a second at least 2 months later. Additional doses may be administered at the discretion of their healthcare provider.

Dr. Peter Hotez, who co-directs the Center for Vaccine Development at Texas Children’s Hospital, has been calling on the FDA to increase access to the bivalent boosters for those who want them. He says for the most part, today’s guidance from the agency makes sense.

“My only question is why the 65 year age cutoff? What was that based on? Ordinarily I would have preferred that it be brought down to 60 or even 50,” Hotez said in an email to CNN.

“For those Americans who understand its importance, we should make second bivalent boosters available. Finally, we’ll soon need guidance about another annual fall booster. Presumably that information comes sometime this summer,” he added.

For immunocompromised children ages 6 months through 4 years, eligibility for additional bivalent doses will depend on the vaccine previously received, the FDA said in a news release.

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