Home » FDA panel endorses Moderna COVID-19 booster shot for seniors and adults at greater risk of infection

FDA panel endorses Moderna COVID-19 booster shot for seniors and adults at greater risk of infection

by Lester Blair
Vials for the Moderna and Pfizer COVID-19 vaccines sit on a tray, ready to be administered at a clinic.
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Thursday was a vote of support by the federal advisory board for booster shots to Moderna COVID-19 for adults 65+, and younger adults who have certain jobs or medical issues that place them at higher risk. 

A booster shot with the same vaccine will only be given in half doses. This is because company data suggests that the lower dose may have less side effects and still work as well.

The Food and Drug Administration committee, whose decision still needs to be verified by a different advisory panel as well as top federal officials, spent the day Thursday reviewing data about the safety and effectiveness of a third dose of Moderna vaccine, as well as information about the impact boosters are having on a COVID-19 outbreak in Israel.

The discussion of booster shots does not change the definition of “fully vaccinated,” which remains two shots for the Pfizer-BioNTech and Moderna vaccines and one for J&J. An additional shot is not required for anyone who must be completely vaccinated to work or participate in an activity. 

The Vaccines and Related Biological Products Advisory Committee voted 19-0 to support boosters for a limited population. A number of members expressed concern that boosters could not be denied to Moderna recipients, even though they were already authorized for them in the case of people who have received Pfizer BioNTech. 

“I don’t see how we can possibly not approve it for Moderna and not have most folks be confused,” said Dr. Steven Pergam, an infectious disease specialist at the Fred Hutchinson Cancer Research Center in Washington. It’s pragmatic.

The committee approved boosters last month for those who have received Pfizer BioNTech vaccine, are 65 years or older and under 65 with certain conditions or are high-risk for COVID-19 from their work.

Patients who have been immunocompromised due to a transplant or chemotherapy can get a third dose of the Moderna and Pfizer BioNTech vaccines.

On Friday, the committee will consider whether second vaccine doses should be authorized for people who received a COVID-19 vaccine made by Johnson & Johnson.

Information on the Moderna booster is not as large or as supportive as the committee considered for the Pfizer-BioNTech shots. 

“The data is not strong, but it is certainly going in a direction that is supportive of this vote,” said Dr. Patrick Moore, a committee member and immunologist at the University of Pittsburgh Cancer Institute.

“The data are not perfect, but these are extreme times and we have to work with imperfect data,” said Dr. Eric Rubin, a committee member, editor-in-chief of the New England Journal of Medicine and a physician at Brigham and Women’s Hospital in Boston.

Rubin made it clear that increasing the number of people who have been vaccinated will be more important than boosters to end the COVID-19 epidemic.

He said, “Vaccinating unvaccinated people here and overseas has a much greater effect than a booster.” We want to convey the message that we must vaccinate unvaccinated people if we are to escape from the problem.

A scientist from the FDA said that a Moderna study of 170 individuals who had received a booster shot failed to achieve its objective of increasing immunity activity against COVID-19 by fourfold. Protection increased more dramatically among people who had low antibody levels – generally, those who were over 65 – than among those whose antibody levels remained high.

According to research, protection against severe diseases and infection does not diminish with age after Moderna vaccine vaccination.

Booster doses of Moderna appeared to be safe with most side effects the same or less than seen with the first two doses, although more people who received boosters complained about swelling or tenderness in the injection site after a third dose than the previous two.

Even though data are preliminary, it was not clear that the rate of myocarditis (a condition that causes swelling of your heart) would be higher after the second dosage.

Israel is continuing to offer booster doses for the youngest adult population. Myocarditis incidences also seem to be lower in Israel than they were after the first dose, Dr. Sharon Alroy Preis, director at the ministry of health’s public health services.

Israel’s population is approximately 80% who have received two shots, and half of those in Israel have had three. The first was given to the oldest residents, then the younger citizens were offered the third.

Alroy-Preis stated that the delta variant was responsible for an increase in infections early in summer. She said that returning to indoor space entry requirements for vaccines did not change the situation. 

Although boosters for those aged 60 and older reduced COVID-19 infected, the national rate continued to rise. She said that the rate of decline began when boosters were made available to younger people.

Alroy-Preis stated that nationwide cases are dropping fast even for those not vaccinated like young children.

She said, “There’s no doubt that I was able to break the curve by implementing the booster dose.”

A licensed practical nurse draws a Moderna COVID-19 vaccine into a syringe at a mass vaccination clinic at Gillette Stadium in Foxborough, Mass., in May.

Members of the committee said the Israeli data convinced them that boosters of both the Pfizer-BioNTech and Moderna vaccines should be recommended, even though the Moderna data was limited. 

Pfizer BioNTech has given at least one dose to more than 245 million Americans, while Moderna was administered to 153 millions. Both vaccines require a two-dose regimen for full vaccination.

Just over 15 million have received the J&J shot and are considered fully vaccinated, according to data from the Centers for Disease Control and Prevention.

A discussion was also held on whether all Americans should receive booster shots.A number of members expressed concern about the concept universal boosters. Data suggests that early shots can still be used to prevent serious illness and hospitalizations. 

Member Dr. Paul Offit, who directs the Vaccine Education Center at Children’s Hospital of Philadelphia, said the vaccines should not be expected to prevent all disease.

Vaccines are still doing an excellent job of preventing severe illness in those under 70, he said, adding that he doesn’t think boosters are needed by everyone, particularly not those under 30, who are at higher risk for myocarditis.

Evidence shows that COVID-19 protection decreases with age.

It’s not clear, Alroy-Preis said, whether a third dose will be enough to provide long-term protection, as happens with some diseases, or whether people will need to get periodic booster shots or vaccines that have been altered to address variants of the virus that causes COVID-19.

Over the coming days, the FDA’s acting Commissioner is expected to approve the decision of the committee. A different committee composed of independent experts will examine the data on Oct. 20-21 and present a recommendation for the head of CDC. Only if she decides to support boosters will they become available to the public. 

Biden Administration has stated it has purchased enough COVID-19 vaccinations to be able to continue providing them for free.

Contact Karen Weintraub at [email protected] and Elizabeth Weise at [email protected]

USA TODAY has coverage for patient safety and healthcare thanks in part to the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. Editorial input is not provided by the Masimo Foundation.

Source: USAToday.com

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