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FDA Advisory Board Recommends Moderna Booster Shot Be Approved

BY October 14, 2021

A Food and Drug Administration (FDA) advisory panel voted Thursday to recommend Moderna booster shots for emergency use authorization, bringing millions of Americans one step closer to being eligible for an additional dose. The panel, called the Vaccine and Related Biological Products Advisory Committee, voted unanimously in favor of authorizing the shots.

The decision will now go to the FDA, which is expected to make a final ruling in the coming days.

The advisory panel’s recommendations for the Moderna booster followed the blueprint it established last month for booster shots of Pfizer-BioNTech’s vaccine: It would be authorized for adults ages 65 and up; people in long-term care facilities; people with underlying medical conditions; and people at high risk of exposure to the coronavirus because of their job. These individuals would be eligible at least six months after their second shot.

Moderna’s booster dose would be given as a half dose of 50 micrograms, compared to the original 100 micrograms given in the initial vaccination series. By contrast, Pfizer’s booster is the same 30 microgram dosage as its initial series.

Moderna’s booster dose would be given as a half dose of 50 micrograms, compared to the original 100 micrograms given in the initial vaccination series. (By contrast, Pfizer’s booster is the same 30 microgram dosage as its initial series.)

Data showed that protection from Moderna’s vaccine has waned: People who were vaccinated earlier in the year were more likely to have a breakthrough infection compared to people who received their vaccinations several months later. Nearly all of these breakthrough infections were caused by the delta variant. The booster dose led to higher antibody levels, including antibodies against the delta variant.

The same group of advisers will convene Friday to discuss a booster shot of Johnson & Johnson’s Covid vaccine. It will also review the results of a National Institutes of Health (NIH) study on “mixing and matching” Covid vaccines. That study found that giving people who initially received the Johnson & Johnson vaccination a booster dose of either Pfizer or Moderna led to a stronger immune response than a second Johnson & Johnson dose.

Next week, a group of advisers to the Centers for Disease Control and Prevention (CDC) will take up the question of who should receive the Moderna and Johnson & Johnson booster shots. If the boosters are recommended, CDC Director Dr. Rochelle Walensky would then sign off, and shots could start going into arms.



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