FDA doesn’t take a position on Moderna‘s application for a booster clotshot, indicating there may not be “sufficient data to support the extra dose.”


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.

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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