Pfizer Receives FDA Approval for Expanded Use of Abrysvo Vaccine
Pfizer's Abrysvo vaccine receives FDA approval for expanded use in infants, protecting against respiratory syncytial virus (RSV). RSV is a leading cause of hospitalization in young children. The vaccine is now approved for use in both older adults an...
Troy D. Hanson
August 22, 2023
Pfizer, the renowned New York drugmaker, has been granted an expanded approval from the U.S. Food and Drug Administration (FDA) for its Abrysvo respiratory syncytial virus (RSV) vaccine. This expanded approval now includes the protection of infants through their mothers.
According to Pfizer, the FDA's green light makes Abrysvo the first and only maternal immunization to safeguard newborns against RSV. RSV is a highly contagious virus that poses a significant risk of respiratory illness, especially for young infants.
It is reported that nearly all children contract an RSV infection by the age of two. In the United States alone, up to 600,000 infants suffer from lower respiratory tract disease caused by RSV each year. This makes RSV one of the leading causes of hospitalization in children under one year old.
Previously, in May, the FDA had approved Abrysvo for the prevention of lower respiratory tract disease in individuals aged 60 years or older. Additionally, a U.S. Centers for Disease Control and Prevention advisory panel recommended its usage for this population in June.
Pfizer's latest achievement expands the reach of Abrysvo, providing a vital defense against RSV to infants as early as birth through their mothers' active immunization.