The US Food and Drug Administration (FDA) has authorized the use of Pfizer’s (NYSE: PFE) respiratory syncytial virus (RSV) vaccine, Abrysvo, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD in infants through active immunization of pregnant women between 32 and 36 weeks of gestation. This marks Abrysvo as the first and only RSV vaccine approved for maternal immunization in the United States, following its earlier approval for use in the elderly population, where it competes with GlaxoSmithKline’s (GSK; NYSE: GSK) Arexvy.
Phase III Data Supports Abrysvo’s Efficacy and Safety
The approval is supported by robust Phase III data demonstrating the efficacy, safety, and immunogenicity of Abrysvo in infants born to healthy individuals who were vaccinated during pregnancy. This clinical evidence has been instrumental in establishing the vaccine’s role in protecting infants from RSV-related diseases.
Ongoing Trials for Expanded Use
Abrysvo is currently undergoing additional trials to evaluate its potential 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 applicability and contribute to a broader public health strategy against RSV.-Fineline Info & Tech
