FDA panel supports Moderna COVID-19 booster shots for older Americans and other adults at higher risk of infection
A federal advisory panel voted Thursday to support booster shots of the Moderna COVID-19 vaccine for people 65 and up, as well as younger adults with certain medical problems or jobs that put them at increased risk for infection.
The booster shot will be a half-dose of the same vaccine already given. Company data suggested that the lower dose was as effective but had potentially fewer side effects.
The Food and Drug Administration committee, whose decision needs to be verified by a different advisory panel as well as top federal officials, spent Thursday reviewing data about the safety and effectiveness of a third dose of Moderna vaccine, as well as the effect 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. Anyone required to be fully vaccinated for work or an activity will not need an extra shot.
The Vaccines and Related Biological Products Advisory Committee voted 19-0 to support boosters for a limited population. Several members said they didn’t feel they could deny boosters to Moderna recipients after authorizing them for people who received the Pfizer-BioNTech vaccine.
“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. “I think it’s a pragmatic issue.”
Last month, the committee supported boosters for people who received the Pfizer-BioNTech vaccine and are either 65 or older, under 65 with certain health conditions, or people who are at high risk for contracting COVID-19 because of their work.
People who are immunocompromised because of an organ transplant, cancer treatment, medication or similar situation can already get third doses of either the Moderna or Pfizer-BioNTech vaccine.
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.
It is clear, Rubin said that getting more people vaccinated with their first shots will do more to stop the COVID-19 pandemic than boosters.
“The effect of a booster is much less than the effect of vaccinating unvaccinated individuals both here and abroad,” he said. “We want to include the message that if we want to get out of the thing, we have to vaccinate the unvaccinated.”
As a scientist with the FDA explained, a Moderna study of about 170 people who received a booster shot, missed its goal of increasing immune activity four-fold against COVID-19. 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.
Protection against infection and severe disease does appear to fade with time after vaccination with Moderna’s vaccine, according to a study that compared people who received Moderna’s vaccine more than a year ago versus about eight months earlier.
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.
There was no indication that rates of myocarditis, a swelling of the heart seen particularly in younger men after a second dose, would increase with the third, although data are still preliminary.
In Israel, which is still rolling out booster doses to the youngest adults, myocarditis incidents also seemed lower after the third dose than after the second, according to Dr. Sharon Alroy-Preis, director of public health services with the country’s ministry of health.
In Israel, about 80% of the entire population has had two shots and about half have had three, rolled out first among the country’s oldest citizens and then progressively younger ones this summer and early fall.
Alroy-Preis said that infections were steeply increasing early this summer, because of the delta variant. Returning to a vaccine passport requirement to enter indoor spaces did not make a difference, she said.
Providing boosters to those over 60 reduced COVID-19 infections in that age group, but national rates continued to climb. It wasn’t until boosters were offered to younger adults that rate began to fall, she said.
Now, cases nationwide are falling fast, even among those who are not vaccinated, such as young children, Alroy-Preis said.
“There’s no doubt in my mind that the break of the curve was the implementation of the booster dose,” she said.
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.
Committee members said they felt strongly about making boosters accessible to health care workers, grocery clerks and others who are potentially exposed to COVID-19 doing their jobs. They put themselves at risk to help others and society cannot afford to have them miss work, even if they don’t become severely ill – they are also more likely to be people of color who face equity issues in medical care, committee members said.
The panel also discussed whether booster shots should be provided to all Americans. Several members said they object to the idea of universal boosters, because data suggests initial shots are still protecting against serious disease and hospitalization.
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.
Data shows that protection against infection with COVID-19 falls off with time since vaccination.
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.
The FDA’s acting commissioner is expected to sign off on the committee’s decision over the next few days. On Oct. 20 and 21, a different independent committee of experts will review the same data and make a recommendation to the head of the CDC. Only if she decides to support boosters will they become available to the public.
The Biden administration has said it has pre-purchased enough doses of COVID-19 vaccine to continue to provide them at no cost to Americans.
Contact Karen Weintraub at firstname.lastname@example.org and Elizabeth Weise at email@example.com.
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