August 22, 2023- Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus 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.
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.
Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as help protect infants through maternal immunization. In May 2023, the U.S. Food and Drug Administration (FDA) approved RSVpreF under the name ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. The approval was followed in June by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) official recommendation for the vaccine for use in adults 60 years of age and older.