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#The Wall Street Journal: FDA staff takes no position on Moderna’s COVID booster

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“#The Wall Street Journal: FDA staff takes no position on Moderna’s COVID booster”

Documents suggest more data may be needed before approval

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.

The FDA’s analysis indicates that the existing Moderna
MRNA,
+1.98%
data may not be enough for the panel to recommend authorizing Moderna’s booster as widely as Pfizer’s
PFE,
-0.50%,
though experts cautioned that the final outcome would be hard to predict.

An expanded version of this report appears on WSJ.com.

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