FDA advisers support vaccine against RSV for pregnant women

DORAL, FL – Pfizer has developed a new vaccine for pregnant women and their newborns against the RSV (Respiratory Syncytial Virus) and FDA advisers unanimously decided that the shot is effective with a 10-4 vote.

If the vaccine passes, “many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, a member of the Food and Drug Administration advisory panel from Children’s Mercy Hospital in Kansas City, Missouri, according to the AP.

This vaccine against RSV, that would be the first of its kind, was backed by Pfizer’s international study of nearly 7,400 pregnant women in which it proved 82% effective at preventing severe RSV during babies’ first three months of life. At age 6 months, it still was proving 69% protective against severe illness.

During an FDA’s panel, conducted on Thursday, where everything related with the vaccine was discussed, the FDA asked its scientific advisers if it would be a matter of concern a slight difference in premature birth between vaccinated moms and those given a dummy shot. Pfizer commited to closely monitor the vaccine’s real-world use for more evidence.

“If you’re in any sense risking premature births with this vaccine, I think there will be a big price to pay,” said Dr. Paul Offit of the Children’s Hospital of Philadelphia, among the panelists who voted “no” on the safety question, the AP reported.

And how does the vaccine work? Women receive a single injection between 24 weeks and 36 weeks of pregnancy with the purpose of making them develop RSV-fighting antibodies that pass through the placenta.

If the FDA gives its final approval, it would mark a second milestone in the decades-long quest to prevent the respiratory syncytial virus, this time in newborns as this month, the FDA gave its green light to the first RSV vaccine for older adults who are at high risk.

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