FDA Will Approve Second Bivalent COVID Booster Shots For Some People

The Food and Drug Administration has decided to allow some people to get a second booster with one of the COVID-19 vaccines that have been updated to target the omicron variant, NPR has learned.

The second shots will be limited to those age 65 and older who got their first shot of the bivalent vaccine made by Moderna or Pfizer-BioNTech at least four months ago, and to those with weakened immune systems who got one of those shots at least two months ago, according to a federal official who was not authorized to speak publicly.

The decision to authorize a second booster is expected to be officially announced within the next two weeks.

While demand for another shot may not be high, the opportunity for extra protection will be welcomed by some people who got their first shot with one of the bivalent boosters last year.

The FDA has only authorized one booster dose of the newest formulations of the COVID vaccines. The agency was instead focusing on planning for an annual COVID booster campaign starting in the fall of 2023 — with vaccines that will have been updated to target whichever variant is expected to be circulating next winter.

But the FDA has now reconsidered the situation. This change will bring the U.S. more in line with the approach taken by Britain and Canada (PDF), which is what some vaccine specialists have been urging — especially with the ample of supply of vaccines available.

“Those doses are going to be expiring and will be thrown out. So it makes sense to have those shots in arms instead of being tossed in the waste basket,” says Dr. Peter Hotez, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine.

The main concern is that the protection people got from their last shot has been fading, not just against getting infected but also possibly against getting seriously ill. So Hotez says people as young as 50 should be able to get a second bivalent booster if they want one.

“It’s better than nothing,” Hotez wrote in an email to NPR about the FDA’s decision. “I think 65 could be lowered to 50 or 55 unless they have specific data that only supports that age cutoff.”

He added: “Historically, when you look at the monovalent vaccines, the protection starts to wane after four or five months. We don’t know if that’s the case with bivalent boosters. But you don’t want to find out the hard way.”

But others scientists aren’t so sure. They say there just isn’t any good evidence showing protection against serious illness has faded significantly or that getting another shot would help that much.

“I have no data to show me that a second bivalent is safe and effective. I have every reason to think it might be. But I don’t actually have data,” says Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group.

In addition, there’s a theoretical possibility that it could kind of backfire — because the bivalent boosters target a strain that’s already been replaced by a new one called XBB.1.5.

“The concern is that if we continue to give boosters against a virus that’s not circulating when we do see the next variant you may not develop a vigorous immune response to that new viral variant,” Poland says.

Since it was authorized in late August, less than 17% of those eligible for the bivalent shot have opted for one, and so the demand for another right now would probably be even lower. But some people would rush to get one if they could, including Katen Moore, 63, a nurse practitioner from North Plainfield, N.J.

“I just don’t want to get COVID again,” says Moore. “I don’t really know what the long-term risks are. And I don’t really want to find out. I don’t want the risk of long COVID. I don’t want the breathing problems. I don’t want the fatigue. I don’t want those things.”

Moore is frustrated that she’s just missing the age cutoff. “The lack of clear information for those of us at the edges is difficult to understand,” she wrote in an email to NPR.

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