FDA Approves Vaccine for Pregnant Mothers to Protect Newborns from RSV

The FDA announced on Monday, Aug. 21 that it approved the first vaccine to help pregnant parents protect their babies from RSV (respiratory syncytial virus).

As reported by CNN, the vaccine, which was made by Pfizer, will be given to expectant mothers in the late stages of pregnancy, providing protection against the virus through the newborns' first six months.

The vaccine, which is named Abrysvo, was tested on over 7,000 pregnant people and their infants. The results showed that it diminished the risk of infants' illness, without needing to see a doctor or be hospitalized.

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The vaccine had previously been approved by the FDA in May for adults aged 60 and older. It proved to be about 67% effective against lower respiratory tract illness, and approximately 86% effective against RSV with three symptoms or more.

"RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization," Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement shared with CNN. "This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease."

Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer for vaccine research and development, added, "ABRYSVO’s approval as the first and only maternal immunization to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health."

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