US: FDA approves first vaccine to protect newborns from Respiratory Syncytial Virus

Aug 22, 2023

Washington DC [US], August 22 : The US Food and Drug Administration (FDA) on Monday approved the first vaccine that protects newborns from Respiratory Syncytial Virus (RSV), CNN reported.
The vaccine, made by Pfizer, is given to mothers late in their pregnancies and provides protection to infants through their first six months of life.
In a trial of more than 7,000 pregnant people and their infants, the vaccine, named Abrysvo, cut the risk that infants needed to see a doctor or be admitted to the hospital.
RSV is a common illness and a major cause of hospitalization in infants and the elderly each year. It typically hits hardest during the winter months, and the last RSV season was longer and more severe than usual, overwhelming children’s hospitals.
Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks in a statement said: “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization.”
“This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease,” he added as per CNN.
As per CNN, there are now several offerings to protect against RSV, including a recently approved antibody shot that can be given to all infants after birth and new vaccines for people 60 and older.
Pfizer’s senior vice president and chief scientific officer for vaccine research and development Annaliesa Anderson said in a statement: “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.”
Pfizer has said that maternal vaccination could prevent up to 16,000 hospitalizations and more than 300,000 visits to the doctor due to RSV each year if the vaccine were universally applied.