Saturday, June 3

FDA advisers vote in favor of Moderna booster dose

(CNN) — Vaccine advisers to the United States Food and Drug Administration (FDA) voted unanimously on Thursday to recommend the authorization of emergency use of a booster dose of the covid-19 vaccine. by Moderna.

The FDA’s Advisory Committee on Vaccines and Related Biologics agreed that a booster dose would be safe and effective for some people six months after completing the primary vaccination schedule.

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

All 19 committee members supported the authorization of a 50 microgram booster dose – half the size of the 100 microgram doses used in the primary vaccination schedule – at least six months after the second dose and only for certain groups: people 65 years of age or older, people 18 to 64 years old who are at high risk of severe COVID-19, and people 18 to 64 years old whose exposure to coronavirus in their environments or work puts them at risk of complications or a serious illness if they catch COVID-19.

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Moderna’s request referred to groups that have already been authorized to receive a booster dose of Pfizer’s mRNA vaccine.

Arguments in favor of the reinforcement of Moderna

The third doses of Moderna and Pfizer vaccines are already licensed for some immunosuppressed people.
Committee members said they were not entirely convinced that the data showed that reinforcement was necessary or that it increased protection.

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“The data is not perfect, but these are 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 a professor at Harvard’s TH Chan School of Public Health.

“We cannot afford health workers, even if they are not sick, to test positive and become infected and have to stay home without working, because in some parts of the country there is a shortage of health workers and there is exhaustion everywhere,” said Dr. Stanley Perlman, Professor of Pediatrics at the University of California, San Diego.

Johnson & Johnson, also up for vote

The Advisory Committee on Vaccines and Related Biologics meeting will continue on Friday. Members are expected to vote tomorrow on Johnson & Johnson’s vaccine boosters and hear a presentation on the vaccine combination.

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The FDA’s independent advisory committee typically discusses and makes recommendations to the agency about vaccine authorizations and approvals, and then the agency makes the final decision on whether to green-light a drug.

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

The Advisory Committee on Immunization Practices The CDC is already scheduled to discuss the reinforcements on October 21.

Jacqueline Howard contributed to this report.

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