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FDA Advisers Recommend Emergency Authorization of a Booster Dose of Moderna's Covid-19 Vaccine

Vaccine advisers to the US Food and Drug Administration voted unanimously Thursday to recommend emergency use authorization of a booster dose of Moderna's Covid-19 vaccine.

Posted: Oct 14, 2021 5:11 PM

Vaccine advisers to the US Food and Drug Administration voted unanimously Thursday to recommend emergency use authorization of a booster dose of Moderna's Covid-19 vaccine.

The FDA's Vaccines and Related Biological Products Advisory Committee agreed use of a booster dose would be safe and effective in some people six months out from their primary series.

Moderna had asked for emergency use authorization for a half dose of its vaccine to be used as a booster for certain people.

All 19 members of the committee supported the question:

Do available data support the safety and effectiveness of Moderna Covid-19 Vaccine for use under EUA as a booster dose (50 mcg mRNA-1273) at least 6 months after completion of a primary series in the following populations:

Individuals 65 years of age and older

Individuals 18 through 64 years of age at high risk of severe Covid-19, and

Individuals 19 through 64 years of age whose frequent institutional or occupational exposure to SARS-Covid-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19

Moderna's request mirrored the groups authorized to receive a booster dose of Pfizer's mRNA vaccine. Third doses of the Moderna and Pfizer Covid-19 vaccines are already authorized for some immunocompromised people.

The Vaccines and Related Biological Products Advisory Committee meeting will continue Friday, when members are expected to vote on boosters for the Johnson & Johnson vaccine, and will hear a presentation on mix-and-match vaccines.

The FDA's committee of independent advisers typically discusses and makes recommendations to the agency around vaccine authorizations and approvals, and the agency then makes the final decision about whether to OK a vaccine.

If the FDA gives emergency use authorization to Moderna boosters, vaccine advisers to the US Centers for Disease Control and Prevention will meet to discuss which groups to recommend them to. Typically, shots can be administered once the CDC director signs off on the recommendation.

CDC's Advisory Committee on Immunization Practices is already scheduled to meet to discuss boosters from 10 a.m. to 5 p.m. ET October 20-21.


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