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An advisory panel to the Food and Drug Administration on Thursday unanimously recommended that the agency approve a booster dose of the Moderna COVID vaccine at least six months after completing the initial two-dose regimen.
The recommendation applies to people aged 65 and over, people between 18 and 64 who are at high risk of severe COVID, and people of the same age group whose occupational or institutional exposure puts them at high risk of COVID.
The recommendation reflects the approval that the FDA granted Pfizer-BioNTech in September.
The 19-0 vote came after presentations by representatives of the FDA and Moderna and a discussion in the committee. The FDA usually follows the advice of its advisory committees, but is not required to do so.
Moderna’s COVID-19 vaccine booster is half the dose of the first vaccinations used in its two-shot vaccination – 50 micrograms of mRNA versus 100 micrograms.
To set the stage, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, made introductory remarks as the meeting began Thursday morning. “The vaccines are still very effective against serious consequences like hospitalization,” he said. “The vaccine’s effectiveness against mild and moderate illness seems to deteriorate over time. And mild to moderate illnesses can lead to blood clots and long-term COVID. ”
The panel heard from researchers in Israel who shared their experience with the Pfizer BioNTech booster, which uses the same type of mRNA technology as Moderna’s vaccine.
“Giving the booster dose has helped Israel curb infections and severe cases in the fourth wave,” said Dr. Sharon Alroy Prize, Director of Public Health, Israel Ministry of Health. An analysis of the side effects, including heart inflammation, is comforting, she said, especially on the most worrisome issues. “I am very confident about the serious events.”
Several committee members said the Israeli data shed important light on the role of boosters and was compelling.
Some committee members said that consistency with previous actions on the Pfizer BioNTech booster is also important.
“I support that [emergency use authorization] because we’ve already approved it for Pfizer and I don’t see how we might not get it approved for Moderna and most US people haven’t been completely confused, “said Dr. Stanley Perlman of the University of Iowa.” I think , it’s a pragmatic topic. “
Shortly before the committee vote, Dr. Eric Rubin, editor-in-chief of New England Journal of Medicine, acknowledged there was incomplete information and some unanswered questions about the Moderna booster. “The data is not perfect,” he said, “but these are extraordinary times and we have to work with imperfect data.”