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Tuesday, October 19, 2021

FDA panel backs low-dose modern COVID shot for booster

by Lauren Niergaard and Matthew Perrone | The Associated Press

US health advisers said Thursday that some Americans who received Moderna’s COVID-19 vaccine at least six months ago should receive a half-dose booster to increase protection against the coronavirus.

The Food and Drug Administration’s panel of external advisors unanimously voted to recommend booster shots for seniors as well as young adults with other health problems, jobs or living conditions that may make them more vulnerable to COVID-19. put at risk.

The recommendation is non-binding but it is an important step toward expanding the US booster campaign to millions more Americans. Many people who got their initial Pfizer shots at least six months ago are already receiving boosters after the FDA authorized their use last month — and they’re the same high-risk group that the FDA advisers said. That they should get the Modern Booster.

But there is no evidence that the time has come to open up booster doses of Moderna or Pfizer vaccines to everyone, the panel insisted – despite the initial Biden administration’s plan to eventually do so.

The coronavirus is still a threat to most unvaccinated people – while vaccinated people have strong protection against serious illness or death from COVID-19.

“I really don’t see the need for a ‘Let It Rip’ campaign for everyone,” said Dr. Michael Kurilla of the National Institutes of Health.

As for the dosage, the initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single shot of 50 micrograms should be enough for the booster.

The agency called on its experts earlier this year to weigh in on when and when they should get the boosters for those receiving the Moderna and Johnson & Johnson shots. The panel will discuss Jammu and Kashmir on Friday.

The FDA will use the recommendations of its advisors in making a final decision for boosters from both companies. Assuming a positive decision, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics as to who should get one.

Many American scientists are divided about exactly who needs boosters and their purpose – whether they are mostly needed by people at risk of severe disease or whether they should be used to reduce even mild infections.

The FDA panel wrestled over whether Moderna produced enough evidence to support its low-dose booster.

As the delta variant increased in July and August, a Moderna study found that people who had recently been vaccinated had a 36% lower rate of “success” infection than those who had been vaccinated long ago. was compared.

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Another study of 344 people found that a six-month booster shot restored virus-fighting antibodies to protective levels — and that included a big jump in antibodies able to target the delta variant. But this was a small study, and only half of them got the exact range of doses given under the Modern Booster campaign.

“The data itself is not strong but it is certainly going in a direction that supports this vote,” said Dr. Patrick Moore of the University of Pittsburgh.

And many advisors worried that boosting with a lower dosage could cost people some of the potential benefit of a full-strength third shot.

“It can really have a tremendous impact on sustainability,” Kurilla said.

Moderna said it chose the lower-dose booster because it caused fewer uncomfortable shot reactions such as fever and pain, but also has more vaccine available for global supply.

A very rare side effect of both Moderna and Pfizer vaccines is inflammation of the heart, especially in young men shortly after the second dose – and a longstanding question is whether the second dose could lead to more cases. Moderna’s booster study was not large enough to detect such a rare risk.

But Israel soon began offering the Pfizer booster to a larger population than the US. On Thursday, Israel’s Ministry of Health’s Dr. Sharon Alroy-Price told the FDA panel that after 3.7 million booster doses have been administered, there is no indication that the additional shots are any riskier.

Because the Moderna vaccine is similar, FDA advisors found the data to be reassuring.

While Pfizer’s boosters are only for certain high-risk groups of Americans, Israeli officials attribute the widespread booster use in their country to halting the delta surge.

“There is no question in my mind that the breaking of the curve was due to booster doses,” Alroy-Preis said in response to FDA advisories, who noted that other countries have reduced delta cases without widespread booster use.

But the FDA’s advisers also highlighted a confusing issue: People with severely weakened immune systems may receive a third full dose of Moderna Vaccine soon after their initial vaccination—so a longstanding question is whether they should even be eligible for a booster. should be eligible, which will be their fourth dose.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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