FDA approves RSV vaccine for pregnant women

SPRINGFIELD, Mass. (WWLP) – The FDA has approved a new vaccine for pregnant people that promises to protect newborns from RSV.

This is the second vaccine the FDA has approved in the last month to protect babies from the deadly respiratory virus, and this one is given to pregnant people in order to pass antibodies to the fetus, protecting the baby once it is born for the first six months of its life.

RSV is a typically mild lower respiratory infection that infects most children by the time they are two, but if the infection causes pneumonia or bronchiolitis. It can be extremely dangerous and leads to more than 300 deaths in kids under five each year in the U.S.

The new shot is approved for pregnant people between 32 and 36 weeks. In clinical trials, it lowered the risk of severe disease from RSV by 82 percent within three months of birth, and 69 percent through six months.

Before Pfizer’s shot can be distributed to the public, an advisory committee to the Centers for Disease Control and Prevention must still recommend who should receive it.

The due diligence is done, though, clinical trials are complete and have been reviewed by the FDA, revealing one side effect that will appear as a special warning label.

Observed side effects for the pregnant mother include fatigue, headache, injection site pain, muscle pain, nausea, joint pain, and diarrhea. It also had an observed, but statistically insignificant effect on pre-term births.

People who received a placebo vaccine during the trial delivered their babies before 37 weeks at a rate of 4.7 percent. For people that received the vaccine, that rate increased to 5.7 percent. It’s important to note that both rates for the study of 74 hundred people were well below the rate of the general population without the shot or placebo of 10 percent.