FDA Approves First RSV Vaccine, But Some Experts Say Weak Safety, Efficacy Data Suggest Benefits Don’t Outweigh Risks

Michael Nevradakis

Describing it as a “long-sought scientific achievement,” the U.S. Food and Drug Administration (FDA) on Wednesday approved Arexvy, the first vaccine for respiratory syncytial virus (RSV).

GlaxoSmithKline Biologicals (GSK) developed Arexvy under the FDA’s Priority Review designation. The FDA approved it for people ages 60 and older.

… And according to the National Vaccine Information Center (NVIC), “Cost analysis data presented to the ACIP [Advisory Committee on Immunization Practices] did not show the RSV vaccines to be cost-effective at reducing the burden of costs associated with RSV illness.”

Nevertheless, more RSV vaccines are expected to receive FDA approval this year — including a Pfizer RSV vaccine for pregnant women that led to a high incidence of adverse events for both the women and their infants during clinical trials, as well as several deaths and stillbirths.

Image: RF._.studio @ Pexels

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