Final data from a late-stage study published in the New England Journal of Medicine has revealed that Pfizer’s RSV vaccine, RSVpreF, was discovered to be 82% effective in preventing severe lower respiratory tract illness in infants when administered to expecting mothers in the second half of their pregnancy,
The research was halted early when it was clear that the vaccine was effective, and the United States Food and Drug Administration (FDA) is expected to make a decision on its use by August.
RSV is a common respiratory virus that causes severe infections in infants, and Pfizer’s vaccine could be the first available maternal vaccine to prevent the disease in infants.
Also, AstraZeneca and Sanofi are developing a single-dose antibody, nirsevimab, for RSV prevention in infants, which is under review by FDA.
In the study, severe illness happened within three months in six infants whose mothers took the vaccine, compared with no fewer than 33 infants from the placebo group that contracted serious RSV infections. 3,570 infants were evaluated by the study and Pfizer’s vaccine met one of the two main aims of the trial.
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