The FDA approved Pfizer’s Abrysvo based on the findings from the Phase III MATISSE clinical trial. Credit: Pfizer.

The US Food and Drug Administration (FDA) has granted approval for Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, for use in pregnant women to offer protection for their babies.

The bivalent RSV prefusion F (RSVpreF) vaccine is administered between 32 and 36 weeks of gestation. It is indicated to prevent RSV-caused lower respiratory tract disease (LRTD) and severe LRTD in infants from birth until the age of six months.

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Based on findings from the Phase III MATISSE clinical trial in 7,000 pregnant individuals and their infants, the regulatory agency granted the approval.

The trial analysed the safety, efficacy and immunogenicity of the vaccine in infants born to healthy people who were inoculated during the gestation period.

The company obtained FDA approval in May 2023 for the vaccine indicated to prevent LRTD in those aged 60 years and above.

Pfizer Vaccine research and development senior vice-president and chief scientific officer Annaliesa Anderson stated: “Abrysvo’s approval as the first and only maternal immunisation to help protect newborns immediately at birth through to six months from RSV marks a significant milestone for the scientific community and for public health.

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“We are incredibly grateful to the clinical trial participants and study investigator teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available.

“Today, a long-sought-after goal to deliver a maternal vaccine that will help protect infants six months of age or younger – when they are at greatest risk of possible serious consequences from RSV – has been achieved.”

The company has also commenced two trials of Abrysvo for RSV in children aged two to 17 years and adults aged 18 to 60 years.