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FDA vaccine advisers meet to review Moderna Covid-19 vaccine recalls

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This is the first part of a two-day meeting of the Vaccines and Related Biologics Advisory Committee that will also include a vote on Johnson & Johnson vaccine recalls and a presentation on combination vaccines. Thursday’s agenda focuses on Moderna boosters and includes a presentation from Moderna and one from the FDA, which will provide its data assessment of Moderna’s boosters.

Moderna is seeking permission for a 50 microgram booster dose – 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 request reflects the groups authorized to receive a booster dose of Pfizer’s mRNA vaccine. Third doses of Moderna and Pfizer Covid-19 vaccines are already authorized for some immunocompromised people.
Thursday’s VRBPAC meeting, which will be broadcast online, is expected to last until 4:45 p.m. ET. A two-hour discussion and voting period is scheduled to begin at 2:45 p.m. ET.
On Thursday, the committee heard from Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, who recently took the interim lead of the agency’s Office of Vaccine Research and Review as two of its senior executives were preparing to leave the agency.
FDA to respond to Moderna, J&J Covid-19 recall questions, including mix-and-match plans

T
Hey also heard from Israeli researchers who had previously spoken in favor of Pfizer’s recall request.

Most Israelis received the Pfizer vaccine, and the country began rolling out boosters long before the United States. Dr Sharon Alroy-Preis of the Israeli Ministry of Health told FDA advisers on Thursday that, as it began offering booster doses to more age groups, the percentage of tests positive for Covid-19 fell to 2.6%, and the overall incidence of severe cases decreased.

“The booster dose in Israel has been effective and, so far, has a similar safety profile to other doses,” Alroy-Preis said.

“We have improved protection against confirmed infections for all ages 16 and over. We have improved protection against serious illnesses for those 40 and over,” said Alroy-Preis. “It could impact even those under 40 for serious and critical illness and death.”

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 meet to discuss boosters from 10 a.m. to 5 p.m. ET on October 20 and 21.

Jacqueline Howard of CNN contributed to this report.

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