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 iNOlder 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 vaccinein 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
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.
U.S. INDICATIONS FOR ABRYSVO
ABRYSVO 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
U.S. IMPORTANT SAFETY INFORMATION FOR ABRYSVO
- ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
- For pregnant individuals: to avoid the potential risk 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, and 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)
View the full Prescribing Information.