FDA advisory committee unanimously recommends Moderna booster shot
An FDA advisory committee on Thursday unanimously recommended the authorization of a booster dose of Moderna’s COVID-19 messenger RNA vaccine for certain people, to be given at half the regular dose.
The 19-0 vote by the Vaccines and Related Biological Products Advisory Committee recommended that a 50 µg booster shot be available at least 6 months after the primary two-dose series for people aged 65 years or older, people aged 18 to 64 years at high-risk for severe COVID-19, and people aged 18 to 64 years whose occupational or institutional setting puts them at an increased risk for serious complications.
The recommendation aligns with what the FDA has already authorized for booster doses of the Pfizer-BioNTech mRNA vaccine.
Although the vote was unanimous, some members of the advisory committee did not wholeheartedly agree with the recommendation for all age groups.
“I worry about this broad use [of boosters] now,” Paul A. Offit, MD, director of the Vaccine Education Center at The Children’s Hospital of Philadelphia, said during the meeting. “Certainly, I don’t agree with [booster doses] down to 18 years of age at all. Maybe 30 [years], I’d feel a little better, because the 18-year-old is at higher risk of myocarditis.”
Offit said he continues to think that using terms like “breakthrough infections” sends the wrong message and makes people believe they are not protected unless they receive a booster dose.
“I understand we are in a pandemic, and [vaccinated people] have some less shedding, but I think if you want to control shedding, we just have to vaccinate the unvaccinated,” Offit said. “I am uncomfortable how we tripped down the line here, regarding the universal booster dose, which I think is just wrong.”
The FDA will now take up the committee’s recommendation. If Moderna boosters are authorized, the CDC’s Advisory Committee on Immunization Practices will make clinical recommendations for the shots. That committee has a 2-day meeting scheduled for next week.
The FDA advisory committee is scheduled to meet again on Friday for another daylong discussion of booster doses of the Johnson & Johnson vaccine. The meeting will also include a discussion about an NIH study that analyzed the mixing and matching of different vaccines for booster doses.
Perspective
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For Moderna’s half-dose vaccine boosters, just as it was the case for Pfizer boosters, the key question to focus on is whether there is evidence of erosion of protection against hospitalization with COVID-19.
In those age or risk groups where this has occurred a booster may be warranted. To my knowledge, it is unclear what benefit those at low risk for hospitalization gain from a booster as there is not enough data to show that boosters protect for a significant amount of time against mild breakthrough infections. This may be more apparent with Moderna’s vaccine, as it has been associated with less waning than other COVID-19 vaccines.
Overall, I think that boosters should be recommended solely for high-risk groups based on clinical — not antibody — data. Improved second generation or “mix and match” vaccines may ultimately prove to be the solution to waning immunity and mild breakthrough infections because frequent boosting to prevent mild illness does not seem to be a viable long-term strategy.
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FDA. Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 meeting announcement. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-14-15-2021-meeting-announcement. Accessed Oct. 14, 2021.
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