Federal regulators approved a maternal RSV vaccine on Aug. 21 that would be administered during pregnancy to protect infants from severe illness.
It’s the latest in a new arsenal of immunizations against the common respiratory virus that is the leading cause of hospitalization in young children and kills thousands of seniors annually.
“This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease,” Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said in a statement. But there’s another way to protect young children in the interim. Earlier this month, regulators approved the monoclonal antibody treatment Beyfortus given directly to infants and high-risk toddlers to prevent severe RSV illness. The treatment essentially acts as a vaccine by preventing severe RSV cases for five months, enough for one RSV season.
The agency also noted a slightly higher percentage of Abrysvo recipients experienced pre-term births compared with placebo recipients . It was unclear whether the vaccine caused the imbalance, but providers are advised to avoid the risk of pre-term birth by administering the vaccine between weeks 32 and 36 of gestation.
An unusual surge in RSV cases last year overwhelmed some children’s hospitals and pediatric offices. Experts and health officials say it may have been an anomaly triggered by the coronavirus pandemic. Among the theories: Toddlers who were not exposed as infants because of social distancing and masking may have been more susceptible, and children who contracted mild or asymptomatic COVID-19 cases may have had weaker immune systems.
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