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

A major advisory panel of the Food and Drug Administration unanimously recommended Thursday booster doses of Moderna’s Covid-19 vaccine to people 65 and older and other Americans at risk, a critical step before the United States begins giving its third vaccines to some of the most out of 69 million. People who originally received this vaccine.

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

While the agency has not always followed the advice of its committee, it often does. The FDA’s final decision on Moderna boosters may come within days. The CDC’s vaccine advisory committee is then expected to vote on the FDA’s proposal next week. If recommended and approved by the CDC, booster doses can begin immediately for eligible Americans who have completed their immunization at least six months in advance.

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 a single dose of the vaccine. The World Health Organization is urging rich countries to stop distributing boosters, and some scientists say they are not convinced that most Americans need boosters right now.

The Biden administration hopes that giving US residents additional doses will ensure long-term and lasting protection against severe disease, hospitalization, and death as the fast-moving variable delta continues to spread.

Dr. Peter Marks, the FDA’s chief vaccine regulator, addressed the committee Thursday before the vote, telling the expert panel that the agency encourages “all different perspectives” regarding “complex and evolving” data.

“However, as we move forward, I would like to request that we do our best to focus our deliberations on the science related to the application under consideration today, and not on the operational issues of a booster campaign on issues related to global equity in vaccines,” he added.

Moderna applied for approval for a booster dose from the U.S. Food and Drug Administration on September 1. The company said the findings are based on a clinical trial of nearly 170 adults, fewer than the 318 people studied for a booster dose of Pfizer. Moderna said the third shot at half the dose — 50 micrograms — used for the first two pricks was safe and produced a strong immune response.

When approved, the company plans to send a letter to health care providers outlining the difference in the third shot dose, Dr. Jacqueline Miller, the company’s head of infectious disease research, said during a presentation Thursday.

Side effects of Moderna’s boosters were comparable to those seen after the second dose, the company wrote in a document released by the U.S. Food and Drug Administration on Tuesday. Most adverse reactions were of low severity, and Moderna reported no cases of rare carditis, myocarditis, or pericarditis, in trial participants for up to 29 days after they received their boosters.

Before recommending the third shot, the committee heard multiple presentations, including from health authorities in Israel, which had begun providing reinforcements to its residents before many other countries. The state used mostly Pfizer’s vaccine but some Moderna boosters were given.

The country has conducted 3.7 million third shots since it began its booster campaign in late July, with nearly a third of the additional shots for people aged 60 or older, Sharon Alroy-Press, director of public health services at the Israeli Ministry of Health, told the committee.

It provided data to suggest that people who received a booster dose were less likely to develop Covid or become seriously ill. So far, she said, officials have identified 17 cases of myocarditis or pericarditis after the third doses.

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

This is an evolving story. . Please check back for updates


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