FDA Staff Don’t Take Position on Moderna Covid-19 Booster

Food and Drug Administration staffers didn’t take a firm stance on Moderna Inc.’s application for a booster dose, indicating there may not be sufficient data to support the extra dose. FDA staff, after reviewing a drugmaker’s application, often weigh whether it should be given a go-ahead. But they also didn’t take a position on Pfizer Inc.’s booster request, later granted. FDA staff reviews are part of the normal process before the agency makes a decision whether to clear a product. In documents made public Tuesday, FDA staff simply restated Moderna’s request and analyzed Moderna’s study data. The extra dose of Moderna’s vaccine appeared to be safe and work well, but the staff said its benefit would depend on how much the protection from the primary series has waned.