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

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A key Food and Drug Administration advisory committee unanimously recommended Thursday that booster shots of Moderna’s Covid-19 vaccine be given to people aged 65 and older and other vulnerable Americans, a crucial step forward that the United States can begin giving third injections to some of the more than 69 million people. people who initially received this vaccine.

The non-binding decision by the FDA’s Vaccines and Related Biologics Advisory Committee would align guidelines for Moderna on third injections of the Pfizer and BioNTech vaccine. These shots were cleared less than a month ago to a wide range of Americans, including the elderly, adults with underlying health conditions, and those who work or live in high-risk settings like health workers and grocers.

Although the agency did not always follow the advice of its committee, it often does. A final FDA decision on Moderna boosters could be made in a few days. A CDC vaccine advisory committee is then expected to vote on the FDA’s proposal next week. If it recommends approval and the CDC approves it, booster injections could begin immediately for eligible Americans who completed their vaccinations at least six months ago.

Booster shots have been a controversial topic for scientists – inside and outside of government – especially since many people in the United States and other parts of the world have yet to receive them. even a single dose of vaccine. The World Health Organization urges rich countries not to hand out boosters, and some scientists say they’re not convinced most Americans need boosters right now.

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

After Moderna’s unanimous vote on Thursday, committee member Dr Patrick Moore said data submitted by the company for authorization of a recall “was not well explained,” adding that he had voted yes more on “intuition”.

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

The Biden administration hopes that giving the U.S. population additional doses will provide long-term, lasting protection against serious illness, hospitalization, and death as the rapidly evolving delta variant continues to spread.

Dr Peter Marks, the FDA’s main vaccine regulator, addressed the committee Thursday ahead of the vote, telling the expert panel that the agency encourages “all different views” on the data ” complex and evolving ”.

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“That said, as we move forward, I would ask that we do our best to focus our deliberations on the demand-related science under consideration today, and not on the operational issues related to a recall campaign on the issues related to global equity in vaccines, ”he added. he added.

Moderna applied for clearance for a booster dose from the FDA on September 1. The company said the results are based on a clinical trial of around 170 adults, which is less than the 318 people studied for the Pfizer booster. Moderna said a third shot at half the dose – 50 micrograms – used for the first two jabs was safe and produced a strong immune response.

After approval, the company plans to send a letter to healthcare providers explaining the difference in dosage for the third shot, Dr Jacqueline Miller, the company’s head of infectious disease research, said at a presentation Thursday.

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

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Before recommending the third shots, the panel listened to several presentations, including from Israel’s health authorities, who began offering boosters to its population before many other countries. The country mainly used Pfizer’s vaccine, but some Moderna boosters were administered.

The country has administered 3.7 million third injections since the start of its recall campaign in late July, with about a third of the additional injections going to people aged 60 and over, Sharon Alroy-Preis, director of public health services to the Israeli Ministry of Health, told the panel.

She presented data suggesting that people who received a booster dose were less likely to be infected with Covid or become seriously ill. She said authorities 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 is that the administration of booster doses has helped Israel reduce infections and severe cases,” she said. .

This is a developing story. Please check for updates.

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