FDA Panel Recommends RSV Vaccine to Protect Young Infants

An advisory panel to the Food and Drug Administration voted on Thursday in favor of approving a vaccine by Pfizer to prevent the severe respiratory virus that is a potentially deadly threat to infants.

The vaccine would be the first to protect babies from respiratory syncytial virus, or R.S.V., which is the reason many infants are admitted to children’s hospitals each year and kills several hundred under 5 each year.

Fourteen agency advisers unanimously agreed that the vaccine was effective, and the F.D.A. typically follows the recommendations of its advisory panels.

Ten of the 14 agreed that the vaccine was safe, with some airing concerns about elevated rates — not all statistically significant — of preterm births among mothers who got the vaccine compared to those who received a placebo.

The vote follows the F.D.A.’s earlier decision to approve the first R.S.V. vaccine for older adults in the United States. Several other options are still being evaluated.

The Pfizer vaccine…

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This article was written by Christina Jewett and originally published on www.nytimes.com