The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy.
Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the US Food and Drug Administration (FDA) to protect infants through the active immunisation of pregnant individuals.
The FDA’s decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD in infants from birth until they are six months old.
Annaliesa Anderson, senior vice president and chief scientific officer, of vaccine research and development at Pfizer, said: “Abrysvo’s approval as the first and only maternal immunisation to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health.”
The FDA’s decision was supported by positive results from the phase 3 MATISSE trial, in which the vaccine demonstrated 81.8% efficacy in preventing severe medically attended lower respiratory tract illness in infants in the first 90 days after birth, and 69.4% efficacy within 180 days.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants.
Each year in the US, around 500,000 to 600,000 infants experience RSV-caused LRTD and an estimated 58,000 to 80,000 children below the age of five years are hospitalised due to RSV infection.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.”