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

On Thursday, a key FDA advisory committee unanimously recommended booster shots of the Moderna Covid-19 vaccine for people 65 and older and other vulnerable Americans. The vote was a decisive step before the US can begin giving third shots to some of the more than 69 million people who initially received the vaccine.

An optional decision by the FDA’s Advisory Committee on Vaccines and Allied Biologicals will align guidelines for Moderna with Pfizer-BioNTech’s third vaccines. These vaccinations were approved less than a month ago for a wide range of Americans, including the elderly, adults with underlying medical conditions, and those who work or live in high-risk settings such as healthcare workers and grocery stores.

While the agency has not always followed the advice of its committee, it often does. A final FDA decision on Moderna boosters can be made within days. The CDC’s 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 vaccines can be started immediately for eligible Americans who completed immunizations at least six months ago.

Booster vaccinations have been a controversial topic for scientists – both inside and outside 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 refrain from distributing boosters, and some scientists say they are not convinced that most Americans need boosters right now.

At an FDA committee meeting last month, they turned down a proposal to distribute Pfizer and BioNTech booster vaccines 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 third shots should be limited to certain groups.

After Moderna’s unanimous vote on Thursday, committee member Dr. Patrick Moore said the data the company provided for the booster approval “was not well explained,” adding that he voted yes more “by gut”.

“The data itself is inconclusive, but it certainly goes in the direction that supports this vote,” he said.

Some participants stated that boosters should prevent so-called breakthrough infections, which they said are critical to protecting healthcare facilities from overload, while other participants said that third shots should ensure that people at high risk are not suffer from serious illnesses. Some committee members also suggested that the young people might not need boosters, as the first shots in these groups are still lingering.

Dr. Paul Offit, another member, stressed that most people who received the first two doses of Moderna vaccine are still well protected and hoped that this recommendation would not be a “false signal” to the general public.

“If we’re trying to prevent the inevitable, which is a decrease in neutralizing antibodies and a weakening of protection against mild or asymptomatic infection, this is a high bar that we do not adhere to with any other vaccine,” he told his colleagues.

The Biden administration hopes that the introduction of additional doses to the US population will provide long-term and reliable protection against serious illness, hospitalization and death as the rapidly spreading delta variant continues to spread.

Dr. Peter Marks, the FDA’s chief vaccine regulator, spoke to the committee on Thursday ahead of the vote, telling the panel that the agency supports “all different points of view” on the “complex and ever-evolving” data.

“However, as we proceed, I would ask that we do our best to focus our discussions on the science behind the application under review today, rather than on operational issues related to the revaccination campaign or issues related to global vaccine equity, ”he added.

Moderna applied for FDA clearance for the booster dose on September 1. The company said the results are based on a clinical trial of approximately 170 adults, down from the 318 people who studied the Pfizer booster. Moderna said the third half-dose injection – 50 micrograms – used for the first two shots was safe and elicited a strong immune response.

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

The side effects of the Moderna boosters were comparable to those after the second dose, according to a document released by the FDA on Tuesday. Most adverse reactions were of low severity, and Moderna reported no cases of rare heart inflammation, myocarditis, or pericarditis in trial participants within 29 days of receiving the booster.

Before recommending third vaccinations, the group heard several presentations, including from the Israeli health authorities, which began offering boosters to their populations earlier than many other countries. The country used mainly the Pfizer vaccine, but some Moderna boosters were introduced.

Israel has carried out 3.7 million third of vaccinations since the start of the revaccination campaign in late July, with about a third of the additional vaccinations targeting people aged 60 and over, Sharon Alroy-Preis, director of public health at Israel’s Ministry of Health, said. panel.

She presented data showing that people on the booster dose are less likely to contract Covid or become seriously ill. Officials have identified 17 cases of myocarditis or pericarditis after the third doses, she said.

“I think when we look at all the data for Israel, we can say that the introduction of booster doses helped Israel to reduce the number of infections and severe cases,” she said.

– Robert Taui of CNBC contributed to this report.


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