Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for ABRYSVO^™, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both infants through maternal immunization and older adults. ABRYSVO is indicated for:

• Passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth through six months of age following maternal immunization during pregnancy
• Active immunization of individuals 60 years of age and older for the prevention of LRTD caused by RSV

“The approval of ABRYSVO in Europe marks significant progress in the scientific community's efforts to provide meaningful protection against RSV, a common respiratory virus that could potentially be severe and even life-threatening, especially for infants and older adults,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer. “Last year’s significant number of newborns, children, and adults being hospitalized across Europe demonstrated the immense need for protection against severe RSV cases. The approval of the vaccine for both older adults and infants through maternal immunization is a triumph for public health and we hope to see a tremendous impact for future seasons.”

This marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. ABRYSVO is the first licensed vaccine designed and studied explicitly for maternal immunization and now a single dose of the vaccine could be administered in the EU between weeks 24 and 36 of gestation.¹ In addition, ABRYSVO has been studied in adults 60 years of age and older. The marketing authorization includes single-dose use in this population as well.¹

The EU marketing authorization for ABRYSVO is based on evidence from two Phase 3 clinical trials – RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease) and MATISSE (MATernal Immunization Study for Safety and Efficacy).

RENOIR (NCT05035212) is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older. MATISSE (NCT04424316) is a global, randomized, double-blinded, placebo-controlled study designed to evaluate the efficacy, safety, and immunogenicity of RSVpreF against LRTD and severe LRTD due to RSV in infants born to healthy individuals vaccinated during pregnancy.

The efficacy and safety results of RENOIR and MATISSE were published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.

Burden of Disease in Europe

RSV is a contagious virus and a common cause of respiratory illness worldwide.² The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.^3,4,5 In the EU, approximately 245,000 yearly hospital admissions were associated with RSV in children younger than five years of age, with most cases occurring among children under one year old.⁶ The disease burden for older adults is also significant. Each year, the virus causes more than 270,000 hospitalizations and about 20,000 deaths in individuals 60 years and older.⁷