COVID-19 Resource Center

COVID-19 Resource Center

Perspective from Amesh A. Adalja, MD
Source:

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.

October 14, 2021
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FDA advisory committee unanimously recommends Moderna booster shot

Perspective from Amesh A. Adalja, MD
Source:

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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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.

Source: Adobe Stock.
Source: Adobe Stock.

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.