The U.S. FDA has approved Pfizer's Abrysvo for use in pregnant individuals, marking the first and only U.S. approval of a maternal vaccine to help protect infants from lower respiratory tract disease (LRTD) and severe LRTD due to RSV.
Abrysvo, the company’s bivalent RSV prefusion F (RSVpreF) vaccine, was approved 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.
The FDA’s decision was based on data from the pivotal phase 3 MATISSE clinical trial in more than 7,000 pregnant individuals, and including their infants a total greater than 14,000 trial participants.
Abrysvo was first approved in June for the prevention of lower respiratory tract disease in individuals aged 60 years and older. A month prior to Pfizer's approval, GSK won the first-ever RSV vaccine approval in older adults for its vaccine, Arexvy.
AstraZeneca and Sanofi were the first to grab an approval for a RSV preventive option for a broad infant population when their single dose long-acting antibody, Beyfortus, was approved in July.
But the recent nod for Abrysvo means that Pfizer is the only company to have a vaccine that protects both older adults and infants.