Expansion of Abrysvo Approval in the EU

Abrysvo®, an RSV vaccine, has recently received an expansion of its approval in the European Union, making it the vaccine with the broadest indication to date among the three RSV vaccines currently authorized in the region.

Previously, Abrysvo was approved for two specific uses: maternal immunization, which involves vaccinating pregnant women to provide passive protection to their infants, and active immunization for individuals aged 60 and older to prevent lower respiratory tract diseases caused by the Respiratory Syncytial Virus (RSV). The latest approval now allows adults aged 18 to 59 years to receive the vaccine.

This extension in approval comes as a result of findings from the Phase III MONET study, which evaluated the safety, tolerability, and immunogenicity of the RSV vaccine in adults starting from the age of 18, particularly those at heightened risk for RSV-related illnesses due to underlying chronic conditions or immune suppression. Participants included individuals with chronic lung diseases, cardiovascular conditions, and diabetes.

Results from the study indicated that the participants exhibited a neutralizing response to both RSV subtypes, comparable to the response observed in the previous Phase III RENOIR study, which involved over 34,000 adults aged 60 and above where the vaccine's efficacy was previously established. Furthermore, participants in the MONET study demonstrated at least a fourfold increase in neutralizing serum titers for RSV-A and RSV-B one month post-vaccination compared to their pre-vaccination levels.

Abrysvo stands out as the RSV vaccine with the widest range of indications available in the EU. The other two vaccines available on the market, Arexvy® by GSK and mResvia® by Moderna, are currently approved for active immunization only for individuals aged 60 and older, with Arexvy also approved for those aged 50 to 59 years who are at increased risk for RSV disease.

The Standing Committee on Vaccination (STIKO) in Germany currently recommends a one-time RSV vaccination for all individuals aged 75 and above. Additionally, it advises a single RSV vaccination for persons aged 60 to 74 who have severe forms of underlying health conditions and/or reside in care facilities. Vaccination is ideally recommended to take place in September or early October to provide optimal protection for the upcoming RSV season.