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Who Should Get a COVID Booster Now? New Data Offers Some Clarity.

 
Three years into the pandemic, it has become evident that COVID-19 isn’t going anywhere, and neither are vaccine boosters.

Last week, an advisory committee to the Food and Drug Administration unanimously agreed that the vaccine and booster process for COVID-19 needs to be simplified in terms of which version of the shot is offered and when and how often people should receive it. There was less consensus about what that simplified process will look like.

The FDA’s desire to streamline vaccine recommendations is a reflection of just how complicated and confusing they have become.

When the bivalent booster, which targets both the original coronavirus strain and the BA.4/BA.5 omicron subvariants, was rolled out in September 2022, there was little data about how well it would work. But the basis for the decision was relatively clear: The virus is evolving, and so should the vaccine. Over the past few months, as the results of initial studies have come in, the picture has gotten murkier.

The good news is the bivalent booster does appear to provide protection against severe infection, which is critical for high-risk individuals. It “is doing a much better job of protection, both for symptomatic infections” and hospitalizations, said Dr. Eric Topol, executive vice president of Scripps Research.

The relative benefit for low-risk populations, who are unlikely to die or be hospitalized from COVID-19, is less clear. There are also questions of how often people should get boosted and how the vaccine should be updated as the virus evolves.

Here’s what we currently know about the bivalent booster and how to decide when — and if — you should get your next shot.

If you’re high risk, get a booster.

For high-risk people — namely adults 50 and older and people who are immunocompromised or have an underlying condition — the evidence is straightforward: If you haven’t gotten the bivalent booster, you should. Just make sure it’s been at least three months since your last shot or COVID infection.

Supporting this recommendation is data presented by Pfizer and Moderna at the FDA meeting, along with four studies published in January in The New England Journal of Medicine. That research found that people who received the bivalent booster had an increase in antibody levels. This suggests it improved immune defenses against the virus, but it didn’t protect against the new strains as well as it did against the old ones.

“There’s a clear step down” in protection as the variants continue to progress, said Dr. Dan Barouch, a professor of medicine at Harvard Medical School who led one of the studies.

When it comes to protecting against severe disease, the bivalent booster fares well in the real world, research from the Centers for Disease Control and Prevention shows. One study found that it was at least 38% effective at preventing hospitalization for COVID-19, and the more time that had passed since someone’s previous vaccine dose, the more the bivalent booster helped.

Similarly, a second study focusing on adults 65 and older found that people who had received the bivalent booster an average of 30 days prior were 73% less likely to be hospitalized than those who’d received only the original vaccine or the vaccine plus the initial single-strain (or monovalent) booster an average of nearly a year prior.

However, it’s hard to know whether the added benefit of the bivalent booster was because it increased protection against the omicron subvariants or because less time had passed since people got it. Antibodies wane over time — that’s why the CDC and FDA started recommending boosters in the first place — so it’s not surprising people would be better protected the more recently they’d had a shot.

In either case, Barouch said, “for people at high risk of severe complications of COVID-19, it makes a lot of sense to get boosted because it has shown a reduction of severe disease, at least for a brief period of time.”

The boosters also appear to be safe in an overwhelming majority of cases. Last month, the FDA and CDC issued a joint statement that said there was preliminary evidence the bivalent booster may raise the risk of stroke in adults over the age of 65. However, updated data revealed that it was because the comparison group had fewer strokes than normal, not because the recently boosted group had more.

What will boosters look like in the coming months and years?

The FDA has suggested that, for most Americans, the booster could be given annually in the fall, like the flu vaccine, and high-risk individuals could still receive multiple doses a year. It’s not clear when or if it will formally recommend this approach.

Lin has unpublished research comparing outcomes by the number of booster doses people receive per year. His data shows that people who average less than one booster a year have higher hospitalization and death rates than people who get one or more doses. There is a much smaller difference between one and more than one booster dose per year. He said this suggested that an annual booster was sufficient for most people; however, for older adults, even the small benefit derived from multiple boosters a year is probably worthwhile.

Based on all of the recent findings, there is consensus that if you are at high risk, getting a vaccine booster at least annually, and possibly more frequently, continues to be valuable. For young, healthy people, though, the decision of when to get a booster, or whether to get one at all, is more individual. The CDC and FDA recommend boosters for everyone, but some experts are less bullish on the idea.

“I think if you haven’t had a booster in the last six months, and if you’re over age 50 or even over age 40, you’re going to get some added protection from winding up in the hospital or even dying,” Topol said. “The case between age 5 and 40 is less strong because those people” are rarely hospitalized.—NYT