PATH welcomes news of first RSV maternal vaccine licensure

PATH welcomes the recent news of the US Food and Drug Administration’s approval of a new vaccine given in pregnancy to protect infants from respiratory syncytial virus (RSV) disease—the world's top cause of severe respiratory infections and hospitalization in young children. The vaccine, developed by Pfizer, Inc., is the first maternal vaccine to be licensed for the prevention of RSV disease and marks a significant milestone for the scientific community and for infant respiratory health.

Vaccination in pregnancy is a key strategy for protecting infants from RSV disease during the first critical months after birth. Though any child can get severely ill or hospitalized due to RSV, infants are the most vulnerable due to easily blocked small airways. In fact, RSV is responsible for 1 in every 28 deaths that occur before six months of age. Serious complications include bronchiolitis and pneumonia and can harm lung health long term. Vaccination in pregnancy can directly enhance a pregnant individual's immunity and increase natural antibody transfer to the baby across the placenta for protection in early life.

“We applaud this long-awaited progress in RSV prevention. Maternal vaccines have the potential to be important and cost-effective tools for protecting young infants from RSV disease,” says Dr. Bruce Innis, global head of respiratory infections and maternal immunization in PATH’s Center for Vaccine Innovation and Access. “Now that the vaccine is licensed in the United States, an important next step will be to accelerate the timeline to access for low- and middle-income markets, where over 98% of RSV deaths occur. Achieving World Health Organization prequalification will important along that journey.”

In 2019, RSV led to a staggering 33 million episodes of acute lower respiratory tract infection, approximately 3.5 million hospitalizations, and over 100,000 RSV deaths among children less than five years of age worldwide.

For more information about RSV and emerging prevention products, please visit our On the verge of RSV prevention web page.