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

The US Food and Drug Administration (FDA) has  for 鈥檚 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.

Go deeper with GlobalData

  • ReportsLogo

  • ReportsLogo

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

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: 鈥淎brysvo鈥檚 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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile 鈥� free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

鈥淲e 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.

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

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.