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FDA considering RSV vaccine for pregnant people to protect newborns

Pregnant
RSV 010920
Posted at 3:09 PM, May 18, 2023
and last updated 2023-05-18 17:59:26-04

SOUTHFIELD, Mich. (WXYZ) — RSV is a very common childhood illness that most kids get before they turn two years old. RSV is short for respiratory syncytial virus. And here in the US, we have around 34 million RSV infections in kids under five years of age.

Unfortunately, roughly 10% end up at the ER. If the infection becomes severe, pneumonia and bronchiolitis can develop. And those at greatest risk are infants.

This single-dose shot made by Pfizer was given to pregnant people in a clinical trial with nearly 7,400 participants. Protective antibodies that developed passed through the placenta to the developing infant. And what the trial found was the vaccine lowered the risk of severe disease among infants in the first three months after birth by 82%. And by six months, the vaccine was 69% effective at preventing severe disease. It was also 51 to 57% effective at keeping the babies from needing to see a doctor due to moderate or severe infections.

In clinical trials, you always have a group that gets the experimental drug and a group that doesn’t get it. So there’s a way to compare how effective the drug is. In Pfizer’s RSV trial, there was a slightly higher number of preterm births in the group that got the experimental vaccine compared to the group that got the placebo shot. 5.7% compared to 4.7%. It’s not considered to be statistically significant, and it could just be due to chance.

As for deaths, there were 17 total in the main study. Five of them were in the group that got the experimental RSV vaccine, and twelve were in the placebo group that did not get the vaccine. Now, of the five deaths in the vaccine group, the FDA agreed that four of them were most likely not related to the vaccine. As for the fifth death, the baby was born prematurely and ten days after the mother received the vaccine. So there is a possibility that the death was connected to the vaccine.

I know that sounds scary, but keep in mind there is no specific treatment for RSV. Here in the US, over 300 children under the age of 5 die each year due to RSV. So if the FDA’s committee votes in favor of this vaccine and the FDA approves it, I think this will help save many newborn lives.