European Commission approves RSV vaccine Abrysvo to help protect adults aged 18-59 against RSV lower respiratory tract disease- Pfizer

 Pfizer Inc.  announced that the European Commission (EC) has issued a decision amending the marketing authorization for  Abrysvo the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18- 59 years of age. This expands the previous authorization for individuals aged 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 for the prevention of LRTD caused by RSV  • Passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth to 6 months of age following maternal immunization during pregnancy.

The amended marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is based on results from the pivotal phase III clinical trial  MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness, NCT05842967),  which investigated the safety, tolerability, and immunogenicity of Abrysvo  in adults 18 through 59 years of age at risk of RSV-associated LRTD due to certain chronic medical conditions. It was also supported by the thousands of persons vaccinated in clinical trials involving Abrysvo n in this age group.  The results of MONeT and other studies have been published in peer-reviewed journals.

"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,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “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.”