FDA panel unanimously recommends Moderna Covid booster shots for at-risk adults

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  • A key FDA advisory committee on Thursday unanimously recommended giving booster shots of Moderna’s Covid-19 vaccine to people 65 and older and other vulnerable Americans.
  • The support is an important step before we start giving the third shot to some of the millions of Americans who originally received Moderna’s vaccine.

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A key Food and Drug Administration advisory committee on Thursday unanimously recommended giving booster shots of Moderna’s Covid-19 vaccine to people age 65 and older and other vulnerable Americans, a significant step before the US exceeds 69 million. Might start giving some of them a third shot. The people who originally received that vaccine.

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The non-binding decision by the FDA’s Vaccines and Related Biological Products Advisory Committee will bring guidelines for Moderna in line with Pfizer and BioNTech’s third shots of the vaccine. Those shots were authorized less than a month ago for a wide range of Americans, including the elderly, adults with underlying medical conditions, and people who work or live in high-risk settings such as health and grocery workers. .

While the agency has not always followed the advice of its committee, it often does. The FDA’s final decision on Moderna Booster could come within a few days. A CDC vaccine advisory committee is expected to vote on the FDA’s proposal next week. If it recommends approval and the CDC supports it, booster shots could begin immediately for eligible Americans who have completed their vaccinations at least six months ago.

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Booster shots have been a controversial topic for scientists – inside and outside the government – especially as many people in the US and other parts of the world have yet to receive a dose of the vaccine. The World Health Organization is urging wealthy countries to put a halt to booster distribution, and some scientists say they are not convinced most Americans need boosters right now.

When the FDA committee met last month, they rejected Pfizer and BioNTech’s proposal to distribute the vaccine booster shots to the general public. Some committee members at the time said they were concerned that there was not enough data to make a recommendation, while others argued that the third shot should be limited to certain groups.

After Moderna voted unanimously Thursday, committee member Dr Patrick Moore said the data the company submitted for the booster’s authorization was “not well explained,” adding that he “gut Voted more on “the spirit of”.

“The data by itself is not strong, but it is certainly going in a direction that supports this vote,” he said.

Some members said the booster should prevent so-called breakthrough infections, which they said was key to keeping health care institutions from being overwhelmed, while other members said the third shot should ensure that people at high risk of severe Will not suffer from disease. Some committee members also suggested that younger people may not need boosters because the initial shots are still in those groups.

Another member, Dr. Paul Offit, stressed that most people who received the first two doses of Moderna Vaccine are still well protected, and added that he hopes the recommendation does not send a “wrong message” to the general public. .

“If we’re trying to prevent the inevitable, which is a decline in neutralizing antibodies and a drop in protection against mild or asymptomatic infection, that’s a high bar for which we have no other vaccine,” he said. told colleagues.

The Biden administration hopes that giving the US population additional doses will ensure long-term and sustainable protection against serious illness, hospitalization and death as the rapidly growing delta variant continues to spread.

The FDA’s top vaccine regulator, Dr. Peter Marks, addressed the committee Thursday ahead of the vote, telling the panel of experts that the agency encourages “all the different perspectives” about the “complex and evolving” data.

“That said, as we move forward, I would ask that we do our best to focus our deliberations on the science related to the application in question today, not on issues related to global vaccine equity as boosters.” On operational issues related to the campaign.” she added.

Moderna applied for authorization of the booster dose with the FDA on September 1. The company said the results are based on a clinical trial of nearly 170 adults, fewer than the 318 people studied for Pfizer’s boosters. Moderna said the third shot at half the dose — 50 micrograms — used for the first two jabs, was safe and produced a stronger immune response.

Upon approval, the company plans to send a letter to health care providers explaining the difference in dosage for the third shot, the company’s head of infectious disease research, Dr. Jacqueline Miller, said during a presentation on Thursday.

The side effects of Moderna’s boosters were comparable to those experienced after the second dose, the company wrote in a document released Tuesday by the FDA. Most adverse reactions were low in severity, and Moderna did not report cases of myocarditis or pericarditis, a rare heart inflammatory condition, in trial participants for up to 29 days after receiving their boosters.

Before recommending the third shots, the panel heard several submissions, including from health officials in Israel, which had begun offering boosters to its population, ahead of several other countries. The country has mostly used Pfizer vaccines but some modern boosters have been given.

The country has administered 3.7 million third shots since starting its booster campaign in late July, with about a third of additional shots going to people age 60 and older, according to Israel’s Ministry of Health in Public Health Services. Sharon Alroy-Preis, director of , told the panel.

She presented data that suggested those who received a booster dose were less likely to be infected with Covid or become seriously ill. He said officials have so far identified 17 cases of myocarditis or pericarditis after the third dose.

“I think we can say when we look at all the data in Israel so far that the administration of booster doses has helped Israel reduce infections and severe cases,” she said.

-CNBC’s Robert Tovey

CNBC Health & Science

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