Infant RSV vaccine could be FDA approved by end of summer

A new Pfizer vaccine to prevent respiratory syncytial virus (RSV) in infants could be approved by the Food and Drug Administration by the end of the summer, according to officials.

The vaccine, once approved and available to the public, would be administered to the pregnant mother while the unborn baby was in utero. The vaccine would then pass through the placenta and protect the baby from RSV once born. The United States has seen a major surge in positive cases of RSV since the lifting of COVID-19 restrictions that prevented the transfer of RSV for some time.

Pfizer confirmed this week that the Food and Drug Administration is currently conducting an expedited review of the RSV vaccine that could wrap up in time to approve the vaccine by the end of August, ahead of the annual RSV surge typically seen in the fall months in the US. “U.S. FDA has set an action date for August 2023,” wrote the pharmaceutical company. “If approved, RSVpreFwould be the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth through six months.”

In clinical trials, Pfizer reported an 82 percent protection rate for infants against RSV when issuing the vaccine to pregnant mothers.