European Commission Approves Pfizer’s ABRYSVO to Help Protect Infants through Maternal Immunization and Older Adults from RSV - Seite 2

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

About ABRYSVO

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

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 two to less than 18 years.⁸ A second trial is evaluating adults ages 18 to 60 years 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.