FDA Staff Don’t Take Position on Moderna COVID-19 Booster
Staff reviewing the drugmaker’s application for booster authorization didn’t take a stance
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Food and Drug Administration staffers in an unusual move didn’t take a stance on Moderna Inc.’s application for a booster dose, indicating there may not be sufficient data to support the extra dose.
FULLY VACCINATED AND HAD COVID-19? NO RUSH FOR A BOOSTER SHOT, EXPERTS SAY
FDA staff, after reviewing a drugmaker’s application, often weigh in whether it should be given a go-ahead. Yet they didn’t take a position on Pfizer Inc.’s booster request, later granted. In documents made public Tuesday, FDA staff simply restated Moderna’s request and analyzed Moderna’s study data.
The staff said the third dose increased the antibody response sufficiently, one endpoint of the study. The extra dose, however, narrowly missed meeting the other study endpoint, of increasing antibody levels by a large magnitude and in a high enough percentage of study subjects.
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The staffers’ review now goes to a committee of outside experts, who are scheduled to meet on Thursday and discuss whether the agency should authorize a Moderna booster shot.
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Despite the lack of a staff endorsement of a Pfizer booster, the agency later authorized an extra dose for seniors and some high-risk adults.