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FDA meeting to consider RSV vaccine for pregnant people

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(NEW YORK) — An advisory committee for the U.S. Food and Drug Administration is expected to meet Thursday to discuss drugmaker Pfizer’s application for a new RSV vaccine for pregnant people, two weeks after the federal agency approved the first RSV vaccine for older adults.

A new study published last month in the New England Journal of Medicine has shown encouraging data that supports the case for an RSV vaccine during pregnancy. The study data was gathered from a phase three clinical trial with pregnant participants in over 18 countries and showed that when the RSV vaccine is given between 24 and 36 weeks gestation, it appeared immunity passed to the fetus through the placenta. The results also showed the vaccine was effective at preventing severe lower respiratory tract infection and reducing hospitalization.

If approved, the RSV vaccine could be given to those who are pregnant, much like other vaccines available now, including those for Tdap (tetanus, diphtheria, pertussis), the flu and COVID-19.

According to the Centers for Disease Control and Prevention, infants and young children, like older adults, are at high risk for RSV, which sends approximately 58,000 to 80,000 children in the U.S. to the hospital each year.

It’s likely the FDA may approve the RSV vaccine option for pregnant individuals as early as this summer, ahead of the winter RSV season, which typically surges between December and February. Pfizer is hoping for an approval by early August but after the FDA approves a vaccine, the CDC would also need greenlight the vaccine too.

An RSV vaccine for children is also currently in the works.

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