FDA Advisers Set to Debate Covid Boosters in Two-Day Summit

(Bloomberg) -- A group of top vaccine experts is meeting on Thursday and Friday to consider whether people who got the Covid-19 vaccines made by Moderna Inc. and Johnson & Johnson should receive booster shots.

The Vaccines and Related Biological Products Advisory Committee will make recommendations to the U.S. Food and Drug Administration, which will ultimately decide whether to allow the boosters, and for whom. The FDA isn’t bound by the experts’ advice, but usually follows it. 

The virtual meetings are scheduled to be all-day affairs, running from 8:30 a.m. to about 5 p.m. on both days. The FDA broadcasts them online via YouTube and other platforms. 

Here’s what to expect:

• On Thursday, the committee will be focused on the Moderna booster. It will hear from company and FDA scientists, as well as Israeli officials who will update the panel on that country’s booster-shot campaign, which has influenced U.S. policy makers’ thinking about the need for additional shots.
• The panel will then discuss the evidence and is expected to vote on recommendations for a booster Thursday afternoon.
• Friday’s session will be dominated by discussion of the Johnson & Johnson booster proposal. The single-shot vaccine has been given to fewer Americans, and is less effective than the messenger RNA vaccines from Pfizer Inc. and BioNTech SE, and Moderna.
• Representatives from J&J and the FDA will present findings to the panel on Friday morning, and the committee will discuss and vote in the early afternoon.
• Also on Friday, the panelists will discuss a National Institutes of Health study on mixing and matching different vaccines. A preprint paper suggested that giving people more than one type of vaccine could increase levels of protective antibodies.
• The panel isn’t currently expected to vote on recommendations for mixing and matching, according to the meeting’s draft agenda.

After the panel votes, the FDA will decide whether to authorize the proposed boosters. If the agency allows them, a separate group of experts that advises the Centers for Disease Control and Prevention will then meet and make further recommendations on how the shots should be given, and to whom. Currently, a meeting of that group is expected next week.

The CDC director will then decide whether to adopt the advisory panel’s recommendations. The agency doesn’t have to adhere to the guidance -- it opted not to adopt some recommendations on the Pfizer booster -- though it often does.

Once the CDC signs off, doctors, drugstores and other immunization sites will be able to begin giving the shots.

Read More:

• Covid Protection Wanes Months After Second Shot, Studies Show
• Moderna, J&J Make Case for Covid Boosters Ahead of FDA Panel
• FDA Staff Makes No Recommendation on J&J Covid Shot Booster
• Vaccine Mix-and-Match Approach Bolsters Antibodies, Study Finds

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