NEW YORK - Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, 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. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

“ABRYSVO’s approval as the first and only maternal immunization to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “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 FDA’s decision is based on the data from the pivotal Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy), a randomized, double-blinded, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and immunogenicity of the vaccine against LRTD and severe LRTD due to RSV in infants born to healthy individuals vaccinated during pregnancy. These results were published in The New England Journal of Medicine in 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 immunization,” said Eric A.F. Simões, M.D., 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.”

RSV is a contagious virus and a common cause of respiratory illness worldwide.1 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.2,3,4 The disease burden of RSV in young children is staggering with virtually all children getting an RSV infection by the time they are two years old.5 In the United States, approximately 500,000 to 600,000 infants experience LRTD due to RSV each year and it is a leading cause of hospitalization in children less than one year of age. 6,7

About ABRYSVO

On March 2, 2022, Pfizer announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for ABRYSVO for prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women. This decision was followed by the FDA’s acceptance of ABRYSVO’s Biologics License Application (BLA) under priority review for infants in February 2023.

Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as help protect infants through maternal immunization. In May 2023, the U.S. Food and Drug Administration (FDA) approved RSVpreF under the name ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. The approval was followed in June by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) official recommendation for the vaccine for use in adults 60 years of age and older.

In July 2023, Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the granting of a marketing authorization for the RSV vaccine candidate, PF-06928316 or RSVpreF, to help protect older adults and infants through maternal immunization from RSV. The CHMP’s positive opinion is being reviewed for each indication by the European Commission (EC). The EC will decide whether to approve RSVpreF, whose European Union (EU) trade name will be ABRYSVO.

In February 2023, Pfizer Japan announced an application was filed with the Ministry of Health, Labor and Welfare for RSVPreF as a maternal immunization to help protect infants against RSV. In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization to help protect infants against RSV.

Pfizer has initiated two additional clinical trials evaluating ABRYSVO. One trial is being conducted in children at higher risk for RSV disease ages 2-<18.8 A second trial is evaluating adults ages 18-60 at higher risk for RSV due to underlying medical conditions, such as asthma, diabetes and COPD, and adults ages 18 and older who are immunocompromised and at high-risk for RSV.8 Pfizer also plans post-marketing studies and surveillance programs to further describe the safety of the vaccine.

INDICATIONS FOR ABRYSVO

ABRYSVO^TM is a vaccine indicated for:

• the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
• pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age

IMPORTANT SAFETY INFORMATION FOR ABRYSVO

• ABRYSVO should not be given to anyone with a history of severe allergic reaction (eg, anaphylaxis) to any of its components
• For pregnant individuals: to avoid the potential risks of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
• Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting
• Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
• Vaccination with ABRYSVO may not protect all people
• In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain
• In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, nausea
• In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo

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