FDA Vaccine Advisors Recommend Emergency Use Clearance for Moderna’s Covid-19 Vaccine Booster Dose



The FDA’s Advisory Committee on Vaccines and Related Biologics agreed that the use of a booster dose would be safe and effective in some people six months into their primary series.

Moderna had applied for emergency use authorization for a half-dose of its vaccine to be used as a booster for some people.

The 19 committee members supported authorization of a booster dose of 50 micrograms – half of the 100 microgram doses used in the primary two-dose vaccine series – at least six months after the second dose, and only for certain groups: people 65 years of age and over; people aged 18 to 64 who are at high risk of severe Covid-19; and people aged 18 to 64 whose exposure to the coronavirus in their environment or work exposes them to complications or serious illness from Covid-19.

Moderna’s EUA application reflected which groups were allowed to receive a Pfizer mRNA vaccine booster dose. Third doses of Moderna and Pfizer Covid-19 vaccines are already authorized for some immunocompromised people.

Committee members said they were not fully convinced the data showed a booster was needed or increased protection.

“The data is not perfect but these are extraordinary times and we have to work with imperfect data,” said Dr. Eric Rubin, editor of the New England Journal of Medicine and professor at the Harvard TH Chan School of Public. Health.

“We cannot afford to have healthcare workers, even if they are not sick, be positive and infected and have to stay at home because in some parts of the country there is a shortage of workers. health and burnout everywhere, ”said Dr. Stanley Perlman, professor of pediatrics at the University of California, San Diego.

Meeting of the Advisory Committee on Vaccines and Related Biologics to Continue Friday, when members are expected to vote on recalls for the Johnson & Johnson vaccine, and attend a presentation on mixed vaccines.

The FDA’s committee of independent advisers typically discusses and makes recommendations to the agency regarding vaccine authorizations and approvals, and the agency then makes the final decision on whether or not to accept a vaccine.

If the FDA grants emergency use clearance for Moderna boosters, vaccine advisers from the U.S. Centers for Disease Control and Prevention will meet to discuss which groups to recommend them to. Typically, shots can be administered after the CDC Director has approved the recommendation.

CDC Advisory Committee on Immunization Practices is already scheduled to discuss boosters on October 21st.

Jacqueline Howard of CNN contributed to this report.



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