FDA approves RSV vaccine to protect babies from birth


The US Food and Drug Administration (FDA) has approved the first vaccine for pregnant individuals to prevent respiratory syncytial virus (RSV) in infants.

Pfizer’s Abrysvo (Respiratory Syncytial Virus Vaccine) was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age.

The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

“RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalisation,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

While RSV most often causes cold-like symptoms in infants and young children, it can also lead to serious LRTD such as pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). In infants and children, the risk of RSV-associated LRTD is highest during the first year of life.

No delay in RSV protection

The FDA’s decision is based on the data from the pivotal Phase III clinical trial MATISSE (MATernal Immunization Study for Safety and Efficacy), which were published in The New England Journal of Medicinein April 2023.

“Newborns and young infants – whose immune systems are still developing and are not yet strong enough to defend against infections – may now be protected from RSV from the moment of birth through maternal immunisation,” said Eric Simões, Clinical Professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine and Children’s Hospital Colorado, Aurora.

“The approval of Pfizer’s Abrysvo is a major triumph as it helps ensure no delay in potential RSV protection during an infant’s most vulnerable first six months of life and offers healthcare providers a new opportunity to help prevent severe RSV.”

Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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