FDA greenlights Pfizer’s ABRYSVO vaccine for shielding infants from RSV

The US Food and Drug Administration (FDA) has granted approval to Pfizer Inc.’s ABRYSVO, a bivalent Respiratory Syncytial Virus prefusion F (RSVpreF) vaccine. This cutting-edge vaccine is designed for the prevention of Lower Respiratory Tract Disease (LRTD) and severe LRTD caused by RSV in infants. Notably, the vaccine works through active immunization of pregnant individuals between 32 to 36 weeks of gestational age. ABRYSVO has been observed to be both safe and effective, and is composed of two preF proteins selected to offer optimum protection against RSV A and B strains.

“ABRYSVO’s approval stands as a landmark achievement in maternal immunization to protect newborns right from birth up to six months from RSV,” highlighted Annaliesa Anderson, Senior Vice President and Chief Scientific Officer for Vaccine Research and Development at Pfizer. This significant milestone comes on the heels of a rigorous Phase 3 clinical trial, named MATISSE, which was designed to evaluate the vaccine’s efficacy, safety, and immunogenicity against LRTD and severe LRTD due to RSV in infants born to vaccinated mothers. The trial results have been published in The New England Journal of Medicine earlier this year.

Pfizer’s ABRYSVO becomes the first FDA-approved vaccine for preventing RSV in infants via immunization of pregnant women. Photo courtesy of Pfizer Inc.

Healthcare experts are hailing the FDA’s decision as a monumental step forward for infant health. Eric A.F. Simões, M.D., Clinical Professor of Pediatrics-Infectious Diseases at the University of Colorado School of Medicine and Children’s Hospital Colorado, emphasized that “the approval of Pfizer’s ABRYSVO is a major triumph, offering healthcare providers a new opportunity to help prevent severe RSV in infants.”

Pfizer previously announced that the FDA granted Breakthrough Therapy Designation for ABRYSVO on March 2, 2022, which was subsequently followed by the FDA’s acceptance of ABRYSVO’s Biologics License Application (BLA) under priority review earlier this year.

To recap, ABRYSVO is FDA-approved for two key purposes, which include prevention of LRTD caused by RSV in people 60 years and older and immunization of pregnant individuals at 32 to 36 weeks gestational age for the prevention of LRTD and severe LRTD due to RSV in infants from birth up to six months of age.

This approval of ABRYSVO by the FDA, supported by robust clinical trials, promises to offer unparalleled protection for newborns during their most vulnerable months, marking a transformative moment in public health and infant care.