Pfizer's Abrysvo Vaccine Approved to Prevent RSV in Adults Aged 18 to 59

On April 1, Pfizer announced that the European Commission has approved a new indication for its bivalent respiratory syncytial virus (RSV) vaccine, Abrysvo, expanding its use to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 to 59. This approval broadens the original indication, which targeted those aged 60 and older, making Abrysvo the most comprehensive RSV vaccine available in the EU.

The new indications include active immunization for adults aged 18 and older to prevent RSV-related LRTD and providing passive protection for infants up to 6 months by vaccinating pregnant women during pregnancy. Abrysvo is an adjuvant-free bivalent vaccine designed to prevent lower respiratory diseases caused by both RSV-A and RSV-B subgroups. By targeting key antigen sites on the F protein (preF), Abrysvo effectively addresses sequence variations across different subgroups.

This approval follows a positive opinion from the European Medicines Agency's Committee for Human Medicinal Products (CHMP) and covers all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The approval is based on the results of the pivotal Phase III MONeT study (NCT05842967).

Pfizer's Chief International Business Officer, Alexandre de Germay, expressed satisfaction with the approval, stating, "We are thrilled that Abrysvo has been approved in the EU to help prevent RSV infections in adults aged 18 and older. This common respiratory virus leads to approximately 158,000 adult hospitalizations annually in the EU, with symptoms that can be severe and life-threatening." He emphasized that expanding the indication to include the 18-59 age group and maintaining the recommendation for vaccination during pregnancy marks a significant public health advancement, potentially reducing the disease burden from RSV in future seasons.

In the U.S., the FDA is expected to approve Abrysvo for high-risk adults aged 18-59 by October 2024. Additionally, GSK's RSV vaccine, Arexvy, has also expanded its indication from those aged 60 and older to include high-risk adults aged 50-59 in both the U.S. and EU.