FDA Votes In Favor Of Pfizer's Maternal RSV Vaccine To Prevent Disease In Infants

The U.S. Food and Drug Administration (FDA) voted that the available data support the efficacy and safety of Pfizer Inc's PFE unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316. 

• The FDA's Vaccines and Related Biological Products Advisory Committee voted 14 to zero on effectiveness and 10 to four on safety. 
• The vaccine candidate is currently under FDA review.
• Pfizer's vaccine candidate aims to prevent medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals.
• The Prescription Drug User Fee Act goal date is in August 2023.
• The FDA recently released briefing documents describing safety data for Pfizer's experimental respiratory syncytial virus (RSV) vaccine in pregnant women as "generally favorable."
• If approved, it could become the first maternal vaccine against the virus.
• In the U.S., approximately 500,000-600,000 cases of MA-LRTD due to RSV occur annually in infants under 12 months of age. Worldwide, there are an estimated 6.6 million cases of RSV annually in infants under six months of age, with approximately 45,000 dying each year from complications associated with the infection, and the vast majority in developing countries.
• New York-based Pfizer wants to launch its RSV vaccine for older adults and pregnant women in the U.S. and Europe later this year.
• Reuters reported that analysts have estimated the market for RSV vaccines to surpass $10 billion by 2030.

Price Action: PFE shares are up 0.44% at $36.63 during the premarket session on the last check Friday.