Pfizer said it will submit an application to the Food and Drug Administration for the RSV vaccine's approval by the end of 2022.
Data shows Pfizer's RSV vaccine given to pregnant mothers as a single dose in the late second or third trimester is effective at protecting newborns, the company said.
RSV is a common respiratory virus that generally causes mild cold-like symptoms, but it can be dangerous for infants younger than 6 months. Pfizer said it will submit an application to the Food and Drug Administration for the vaccine's approval by the end of 2022. The company said it will also submit the results for peer review.
The vaccine was well tolerated with no safety concerns for the mothers or their newborns, according to Pfizer. The mothers were monitored for six months after delivery for any safety concerns, while the babies were followed for at least a year.
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