Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory syncytial virus (RSV) vaccine, Abrysvo. The vaccine is approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy, as well as for active immunization of individuals 60 years and older to prevent LRTD caused by RSV. With this approval, Abrysvo becomes the first RSV shot approved for maternal immunization in the region.
Phase III Data Supports Approval
The approval is supported by Phase III data demonstrating the efficacy, safety, and immunogenicity of Abrysvo in infants born to healthy individuals vaccinated during pregnancy and in the elderly population. These two indications were also approved earlier this year in the US, according to Fineline Info & Tech data, highlighting the vaccine’s potential to protect vulnerable populations against RSV.
Ongoing Trials for Expanded Use
Abrysvo is currently undergoing additional trials for children between 2 and 18 years and adults between 18 and 60 years who are at higher risk for RSV infection. These trials aim to further expand the vaccine’s use and provide protection to a broader range of individuals susceptible to RSV-related complications.-Fineline Info & Tech
