Europe Approves RSV Vaccine for Pregnant Women

Pfizer Inc. recently announced in a press release 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 the first licensed vaccine designed and studied explicitly for maternal immunization. Now, a single dose of the vaccine could be administered in the EU between weeks 24 and 36 of gestation.

In addition, ABRYSVO has been studied in adults 60 and older.

"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," commented Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer on August 24, 2023.

"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 (RSV) seasons."

This authorization is valid in all 27 EU member states, plus Iceland, Liechtenstein, and Norway.

RSV is a contagious virus and a common cause of respiratory illness worldwide. 

In the EU, approximately 245,000 yearly hospital admissions were associated with RSV in children younger than five. 

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 and older.

The virus can affect an infected individual's lungs and breathing passages, potentially causing severe illness or death.

As of August 26, 2023, two RSV vaccines are approved for seniors and available at clinics and pharmacies in the United States.