21May 2023
FDA Advisory Committee Votes in Support of Approval for Pfizer's Vaccine Candidate to Help Prevent RSV in Infants Through Maternal Immunization

FDA Advisory Committee Votes in Support of Approval for Pfizer's Vaccine Candidate to Help Prevent RSV in Infants Through Maternal Immunization

Pfizer's unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate, RSVpreF or PF-06928316, has received positive support from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee voted in favour of the vaccine's effectiveness and safety based on compelling scientific evidence, including Phase 3 clinical trial data involving pregnant individuals and their infants. RSV is a common cause of respiratory illness, particularly affecting young infants and individuals with certain medical conditions. In the US, around 500,000 to 600,000 cases of RSV-related lower respiratory tract disease occur annually in infants under 12 months of age. Worldwide, an estimated 6.6 million cases of infants under six months result in approximately 45,000 deaths annually. Pfizer is the only company pursuing regulatory applications for an RSV vaccine for older adults and maternal immunization to protect infants.

  • #family health

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