U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age

发布时间： 2023-08-28 阅读：328次

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August 21, 2023--Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

ABRYSVO’s approval as the first and only maternal immunization to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health.

RSV is a contagious virus and a common cause of respiratory illness worldwide. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.The disease burden of RSV in young children is staggering with virtually all children getting an RSV infection by the time they are two years old. In the United States, approximately 500,000 to 600,000 infants experience LRTD due to RSV each year and it is a leading cause of hospitalization in children less than one year of age.