Second RSV Vaccines Approved for Seniors

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO™, the company’s bivalent Respiratory Syncytial Virus (RSV) prefusion F (RSVpreF) vaccine.

This FDA approval on May 31, 2023, prevents lower respiratory tract disease caused by RSV in individuals 60 years and older.

On May 3, 2023, the FDA approved the initial RSV vaccine, Arexvy™, which GSK produces.

According to statements, both RSV vaccines could be available for seniors in late 2023.

Other RSV vaccine candidates, including vaccines for pregnant women, are conducting late-stage clinical trials as of June 1, 2023.

The U.S. Centers for Disease Control and Prevention published a report on April 7, 2023, that indicated the 2022–23 RSV season started later than the 2021–22 season but earlier than the prepandemic seasons, suggesting a return toward prepandemic seasonality. 

A study published by the Journal of Infectious Diseases determined that RSV-related fatalities in infants <1 year peaked at one month of age.

Over the 20-year study period, RSV, bronchiolitis, and influenza were listed as the underlying causes of death on 932, 1,046, and 52,293 death certificates, respectively.

Over 95% of these infections in children occur in low- and middle-income countries outside the U.S.