Pfizer RSV vaccine seen as effective against severe disease, FDA documents say

STAT May 16, 2023
Helen Branswell

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

The agency’s analysis said the vaccine was also shown to be effective at preventing non-severe lower respiratory tract RSV disease that required medical attention at 180 days after birth, though at 90 days the vaccine’s efficacy against this endpoint was not statistically significant.

The FDA’s assessment was released in advance of a meeting Thursday of an expert advisory committee, which will study the safety and efficacy data generated in trials of the...

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