FDA Authorizes Another Covid Booster Shot for People Over 65

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The Food and Drug Administration on Tuesday authorized an additional round of bivalent booster shots for adults who are 65 and over as well as people with compromised immune systems. The effort is to ensure ongoing protection against Covid, which is still claiming more than 1,300 lives each week.

The bivalent shots target Omicron variants of the coronavirus. The agency said people who are 65 and older who have not had a bivalent booster shot in at least four months may get another one. For those who are immunocompromised, additional doses of the bivalent vaccine can be given two months after the last shot. Those who are unvaccinated can get a single dose of the bivalent booster, the agency said.

“Covid-19 continues to be a very real risk for many people,” Dr. Peter Marks, the F.D.A. vaccine chief, said. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of Covid-19, which are severe illness, hospitalization and death.”

A nurse supervisor wearing a colorful violet-hued mask and a dark blue jacket prepares a dose of Covid vaccine at a white table.
The Food and Drug Administration on Tuesday approved an additional round of bivalent booster shots to ensure ongoing protection against Covid. Rosem Morton for The New York Times

Although levels of the virus are dipping as the summer months approach, it is still being linked to 1,300 deaths each week, according to data from the Centers for Disease Control and Prevention.

C.D.C. data also show that only 43 percent of people over 65 have received an Omicron booster shot, and just 20 percent of those 18 and older.

The spring booster approval was for the same formula that was released to protect people from the Omicron variant of the virus. An updated vaccine is expected later this year. (The agency on Tuesday also rescinded authorization for the original monovalent vaccines that Americans received in the first mass-vaccination campaign.)

The decision to offer the booster to the most vulnerable this spring is sound for two reasons, said Dr. Daniel Griffin, an infectious disease specialist at Columbia University.

“One is the traditional reason — it protects people from severe disease,” he said. “But there is what I call the superpower where for a matter of three or four months, you get an extra benefit of reducing your risk of even getting infected.”

The C.D.C. typically endorses updated vaccine schedules after F.D.A. authorizations.

The F.D.A. said it intended to make decisions about the recommended vaccine schedule for people younger than 65 after a June advisory meeting. The agency said its advisers would make their recommendations based on whatever strain of the virus is circulating at that time.

The F.D.A. said it expected to make updated formulations of the vaccines for this fall “once the specific strains are selected for the Covid-19 vaccines.”