FDA vaccine advisors meet to consider booster vaccination of Moderna Covid-19

It is the first part of a two-day meeting of the Advisory Committee on Vaccines and Related Biological Products that will also include a vote on boosters for the Johnson & Johnson vaccine and a presentation on mix-and-match vaccines. Thursday’s agenda will focus on Moderna boosters and will include a presentation from Moderna and another from the FDA that will provide its assessment of Moderna booster data.

Moderna is filing for approval for a 50 microgram booster dose – half the size of the 100 microgram doses used in the primary series of the two-dose vaccine – at least six months after the second dose and only for certain groups: people from 65 years; 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 at work puts them at risk of Covid-19 complications or serious illness.

Moderna’s request reflects the groups eligible to receive a booster dose of Pfizer’s mRNA vaccine. For some immunocompromised people, third doses of the Moderna and Pfizer Covid-19 vaccines have already been approved.
Thursday’s VRBPAC meeting, which will be streamed online, is slated to last until 4:45 p.m. ET. A two-hour discussion and voting period begins at 2:45 p.m. ET.
On Thursday the committee heard from Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, who recently took over as assistant director of the agency’s Office of Vaccines Research and Review, when two of its executives left the agency.

You have also heard from Israeli researchers who previously advocated Pfizer’s booster application.

Most of the people in Israel received the Pfizer vaccine, and the country began introducing booster vaccinations well before the United States. Dr. Israel Ministry of Health’s Sharon Alroy Prize told FDA advisors on Thursday that the percentage of positive Covid-19 tests dropped to 2.6% and the overall incidence of severe cases when she started offering booster doses to more age groups.

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

“We have improved protection against confirmed infections for everyone aged 16 and over. We have improved protection against serious illnesses from the age of 40, ”said Alroy-Preis. “It could affect even those younger than 40 for serious and critical illness and mortality.”

The FDA’s Committee of Independent Advisors typically discusses and makes recommendations about vaccine approvals and approvals to the agency, and the agency then makes the final decision on whether a vaccine is okay. When the FDA grants an emergency clearance to Moderna boosters, vaccine advisors from the U.S. Centers for Disease Control and Prevention will meet to discuss which groups to recommend them. Usually, shots can be administered once the CDC director makes the recommendation.

The CDC Advisory Committee on Immunization Practices is already scheduled to discuss booster vaccination October 20-21, 10 am-5pm ET.

CNN’s Jacqueline Howard contributed to this report.


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