The US Food and Drug Administration (FDA) has approved the first vaccine for pregnant individuals to prevent respiratory syncytial virus (RSV) in infants, Pfizer Inc (NYSE:PFE)'s Abrysvo.
The vaccine aims to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through to six months old by immunizing their pregnant parent.
In the United States, between 500,000 and 600,000 infants per year experience LRTD due to RSV and it is a leading cause of hospitalization in children younger than a year old, according to Pfizer.
Abrysvo was approved for use at 32 through to 36 weeks gestational age of pregnancy, administered as a single dose injection into the muscle.
“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 senior vice president and chief scientific officer, Vaccine Research and Development Dr. Annaliesa Anderson said in a statement.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, added: “This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.”
The RSV prevention market is heating up, with Pfizer competing with a rival drug for infants from AstraZeneca and Sanofi.
Earlier this year, Pfizer’s Abrysvo was approved for people aged 60 years and older following GSK’s entrance into the older RSV market.
Pfizer shares traded lower following the news, down 0.8% at US$36.69 late morning on Tuesday.
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