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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-19 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-19, and people of the same age group whose occupational or institutional exposure puts them at high risk of COVID-19.
The recommendation reflects the approval the FDA granted Pfizer-BioNTech’s COVID-19 booster doses 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, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, made introductory remarks as the meeting began Thursday morning. “It is important to remember that the vaccines still offer strong protection from serious consequences, especially for younger age groups,” he said. “The effectiveness of the vaccine against mild to moderate disease seems to decrease over time for the various vaccines. And we need to take into account the fact that mild to moderate COVID-19 can be linked to undesirable outcomes like blood clots and long-term COVID-19, even in those who have breakthrough infections after vaccination. ”
The panel Heard from researchers in Israel who gave an update about experiences with the Pfizer BioNTech booster, which uses the same 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 of the 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 may not approve it for Moderna and have not completely confused most of the US people, “said Dr. Stanley Perlman of the University of Iowa.” I think so. it’s a pragmatic topic. “
Shortly before the committee vote, Dr. Eric Rubin, editor-in-chief of The New England Journal of Medicine, admitted 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.”
After the vote, the panel discussed a separate question from the FDA: Should the use of Pfizer-BioNTech and Moderna boosters be extended to the general population under 65 (but at least 18)? The panel of experts was not inclined to support this.
The FDA’s Marks confirmed that there wasn’t much, if any, appetite for lowering the age range, if at all, for a general increase.
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