Pfizer Inc (PFI). announced that the European Commission (EC) has amended the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to include the prevention of RSV-induced lower respiratory tract disease (LRTD) in people aged 18 to 59. This broadens the prior license for adults 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes:
- Active immunization of individuals 18 years of age and older to prevent LRTD caused by RSV.
- Passive protection against lower respiratory tract disease (LRTD) induced by RSV in infants from birth to six months of age following maternal immunization during pregnancy.
We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease, a common respiratory virus with symptoms that can be severe or even life-threatening,
With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to 6 months of age, ABRYSVO’s expanded authorization for adults aged 18 to 59 in the EU signifies another step for public health by offering the potential to substantially reduce the burden of RSV in future seasons.
Alexandre de Germay
Also Read: U.S. FDA Approved Sanofi’s Qfitlia to Treat Hemophilia
The updated marketing authorization reflects the CHMP’s recent good opinion. The permit is valid in all 27 EU member states, including Iceland, Liechtenstein, and Norway. The approval is based on the results of the pivotal phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults aged 18 to 59 years who were at risk of RSV-associated LRTD due to certain chronic medical conditions. It was also supported by thousands of people who had been vaccinated in ABRYSVO clinical studies in this age bracket. The findings from MONeT and other investigations have been published in peer-reviewed journals.
About ABRYSVO
ABRYSVO is an unadjuvanted bivalent vaccine that was developed to protect against RSV-LRTD independent of viral subgroup. In the prefusion form, the RSV fusion protein (F) is a significant target of neutralizing antibodies and serves as the foundation for Pfizer’s RSV vaccine. Variations in the F protein sequence between the RSV-A and RSV-B subgroups are concentrated at a critical antigenic region, which is a target for powerful neutralizing antibodies.
Source: Pfizer
Last Modified:
Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
