F.D.A. panel approves Moderna vaccine boosters

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Following the steps taken for the Pfizer vaccine, a federal committee on Thursday voted to offer the Moderna vaccine booster to people who are at highest risk of serious COVID-19 disease because of their age, underlying health conditions or who have a high risk of viral exposure where they work or live.

There is not yet enough strong evidence to recommend the booster to the general population, the group agreed.

The unanimous vote by a panel of outside experts for the U.S. Food and Drug Administration will expand the ability of about 70 million Americans to increase their protection with a third shot at pharmacies, doctors’ offices, health clinics and elsewhere.

But boosters, alone, will not end the pandemic, cautioned infectious disease expert Dr. Eric Rubin of Harvard’s T.H. Chan School of Public Health.

“If we’re going to get out of this thing, it’s by vaccinating the unvaccinated,” he said.

Specifically, the panel supported authorization for the Moderna booster for these groups:

·        • People age 65 and older

·        • People age 18 to 64 who are at high risk of developing severe Covid-19

·        • People age 18 to 64 who live or work in situations that increase their risk of serious complications from COVID, such as living in institutions or working in healthcare.

Younger and healthier people show a more robust immune response to the initial vaccines than elders, they said. Secondly, their defense seems to stay stronger, over time. And they are at elevated risk of adverse effects, such as heart inflammation.

“I don’t necessarily see the need for a sort of ‘let it rip’ campaign for boosters for everyone who’s ever been vaccinated,” said immunologist Dr. Stanley Perlman of the University of Iowa.

Recipients of the Moderna booster, like Pfizer recipients would have to wait at least six after their second injection before being eligible for a third shot.

Earlier this week, a review by the U.S. Food and Drug Administration found that a booster shot of the Moderna vaccine – which is half the dose of the initial shots – increased protective antibodies in people who had previously received two doses.

There is growing concern about evidence of so-called mild to moderate “breakthrough infections” among people whose antibody levels have waned.

What remains unclear is whether these falling antibody levels will, over time, increase risk of  severe disease, hospitalization and death might be fading as well.

That’s because antibodies, while easily measured, are only one barometer of immunity, said Dr. Paul Offit, Director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Another arm of the immune system – which deploys B cells, T cells and fresh antibodies—holds a memory of the virus, and is longer lasting. It provided an added measure of protection.

Last month, authorities authorized use of the Pfizer booster in high-risk groups.

But only about 4% of Americans have received this booster, according to the U.S. Centers for Disease Control and Prevention. In the highest risk group of elders, 10% of people have gotten a booster.


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