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FDA vaccine advisors recommend emergency use authorization for the booster dose of Moderna’s Covid-19 vaccine



The FDA’s advisory committee on vaccines and related biological products agreed that the use of a booster dose would be safe and effective in some people six months from their main series.

Moderna had applied for emergency use authorization to use a half dose of the vaccine as a booster for certain people.

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

Moderna’s US application reflected the groups authorized to receive one booster dose of the Pfizer mRNA vaccine. Third doses of the Moderna and Pfizer Covid-19 vaccines are already authorized for some immunocompromised people.

Committee members said they were not entirely convinced that the data showed that reinforcement was needed or that protection was increased.

“The data isn’t perfect, but it’s extraordinary times and we have to work with imperfect data,” said Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and professor at Harvard TH Chan School of Public Health.

“We can’t afford to have health workers, even if they are not sick, be positive and infected and have to stay home from work, as in some parts of the country there is a shortage of health workers and there is exhaustion in everywhere, “said Dr. Stanley Perlman, professor of pediatrics at the University of California at San Diego.

The meeting of the Advisory Committee on Vaccines and Related Biological Products will continue Friday, when members are expected to vote on Johnson & Johnson vaccine enhancers, and will hear a presentation on combined vaccines.

Typically, the FDA’s independent advisory committee discusses and makes recommendations to the agency about vaccine authorizations and approvals, and the agency makes the final decision on whether to accept a vaccine.

If the FDA gives emergency use authorization to Moderna promoters, vaccine advisors at the U.S. Centers for Disease Control and Prevention will meet to discuss which groups we recommend. Traits can typically be managed once the CDC director signs the recommendation.

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

CNN’s Jacqueline Howard contributed to this report.