Boosters targeting omicron may be available earlier than expected: Registrations

The FDA is trying to make available as early as September “bivalent” COVID vaccines, which target two different antigens.

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Robyn Beck/AFP via Getty Images

The FDA is trying to make available as early as September “bivalent” COVID vaccines, which target two different antigens.

Robyn Beck/AFP via Getty Images

The Biden administration may scrap plans to allow more young adults to get second COVID-19 boosters this summer. Instead, officials are trying to speed up the availability of the next generation of boosters in the fall, NPR has learned.

The new strategy aims to balance protecting people this summer with keeping people safe next winter, when the country is likely to be hit by another surge.

But the potential change is facing mixed reactions. The Food and Drug Administration could make a final decision by the end of the week.

The dilemma facing the FDA is that the immunity that many people have acquired from vaccination or infection has worn off. At the same time, the most contagious version of the virus that has emerged so far – the omicron BA.5 subvariant – is making people even more vulnerable.

So while COVID is starting to become more serious than a cold or flu again, most people younger than 50 are not eligible for fourth shots — second boosters — to protect themselves. In response, the FDA was considering opening up eligibility for second boosters to all adults.

But allowing more people to be immunized with the original vaccine now could interfere with plans to boost them with updated, hopefully more protective vaccines in the fall to mitigate the winter surge.

That’s why the administration is considering shifting focus to the next generation of boosters. Moderna and Pfizer-BioNTech were already trying to comply with the FDA’s request to get new, hopefully more potent “bivalent” boosters ready by October or November that target both the original strain of the virus and the omicron BA subvariants .4 and BA.5.

The FDA is trying to get the companies to make those photos available even sooner — possibly in September, according to a federal official familiar with the situation who was not authorized to speak publicly. The potential move was first reported by The Washington Post.

If the bivalent boosters can be expedited, the FDA will skip opening the quadruple vaccines of the original vaccines this summer and simply wait for the new bivalent omicron vaccines in the fall.

The potential shift is causing mixed reactions.

Some think it’s the smartest strategy. Three shots are still protecting most younger, otherwise healthy people against serious disease, they say. And raising people again now, and then so quickly again in the fall, could confuse people, potentially eroding their willingness to take any stimulus, according to some experts.

“I think this will increase confidence,” wrote Dr. Monica Gandhi, a professor of medicine at the University of California, San Francisco, in an email to NPR. “We can’t give a booster every now and then in 1.5 months or two months – that will lower confidence.”

And giving two shots too close together can backfire healthily, according to some experts.

“I think this is the right call,” said Dr. Celine Gounder, a senior fellow at the Kaiser Family Foundation, during an interview with NPR. “If you get a booster now with the original vaccine formulation, that could actually be counterproductive. It could prevent you from getting the second booster dose given this fall and for you to develop an immune response to that booster.”

But others aren’t so sure. They say the new vaccines may not be significantly better.

“People shouldn’t think of them as some kind of magic bullet that gives them super-strong protection,” says Dr. John Moore, an immunologist at Weill Cornell Medicine. “These won’t be magical game-changers because they’re not much better than vaccine boosters already available.”

It is also unclear whether the new boosters could be ready by September. And who knows if BA.5 will be the main virus by fall and winter?

“I don’t see the benefit in waiting for a specific booster of BA.5 as BA.5 may be in the rearview mirror and very well spent in the time available,” says Dr. Peter Hotez, dean of the Baylor College of Medicine National School of Tropical Medicine.

People younger than 50 should at least have the chance to protect themselves now, especially with BA.5 already on the rise, some say.

“You’re talking about you know literally hundreds of millions of people who are at a higher risk than they should be for months,” says Dr. Robert Wachter, chairman of the department of medicine at the University of California, San Francisco.

“And that will mean potentially millions of preventable infections, certainly thousands of preventable hospitalizations, and possibly hundreds of preventable deaths.”

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