FDA weighing approval for RSV vaccine for infants, will decide this summer

Feb. 21 (UPI) -- The U.S. Food and Drug Administration is expected to make a decision on the approval of the first RSV vaccine for infants in August, and Pfizer is a candidate to be among the first producers.

The drugmaker announced that its respiratory syncytial virus vaccine has been accepted for review. The vaccine is designed for infants up to 6 months of age and as a preventive vaccine administered to women while they are pregnant.


The announcement follows a particularly active RSV season that began earlier than usual. The peak season typically occurs between December and February, but numbers were already high in October.

The Centers for Disease Control and Prevention reported RSV hospitalizations peaked at a five-times higher rate per 100,000 in the 2022-23 season than the year before and have remained steadily higher in comparison. The peak of this season came in November when more than five people were hospitalized for every 100,000 in the population.

Pfizer's vaccine has undergone Phase 3 clinical trials and yielded an 81.8% efficacy against severe lower respiratory illness caused by RSV when given to infants within 90 days of birth. It was 69.4% effective through an infant's first six months.


"If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season," Annaliesa Anderson, Pfizer's senior vice president and chief scientific officer for vaccine research and development, said in a statement.

RSV symptoms can include coughing, wheezing and a high fever as well as more minor symptoms such as a runny nose. It can lead to more serious illnesses like pneumonia and bronchiolitis, both of which affect the lungs and airways.

Though RSV is most often associated with its risks to children, it can also be serious for adults, especially the elderly and immunocompromised.

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