FDA may greenlight Pfizer's RSV shot by summer

The FDA will decide whether to approve Pfizer's vaccine candidate for respiratory syncytial virus in August. The shot is administered to expectant mothers and protects infants from severe disease through their first six months of life, the drugmaker said in a Feb. 21 news release. 

In November, Pfizer said clinical trial data indicated the single-dose vaccine, called RSVpreF, was nearly 82 percent effective at preventing severe illness from RSV in infants through the first 90 days of life. Through the first six months of life, it was nearly 70 percent effective. There is currently no approved RSV vaccine. 

"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, PhD, Pfizer's senior vice president and chief scientific officer of vaccine research and development, said in a statement. “We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants."

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