Pfizer gets European Commission marketing nod for RSV vaccine Abrysvo to protect infants, older adults

This 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. ABRYSVO is the first licensed vaccine designed and studied explicitly for maternal immunization and now a single dose of the vaccine could be administered in the EU between weeks 24 and 36 of gestation. In addition, ABRYSVO has been studied in adults 60 years of age and older. The marketing authorization includes single-dose use in this population as well.

The EU marketing authorization for ABRYSVO is based on evidence from two Phase 3 clinical trials – RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease) and MATISSE (MATernal Immunization Study for Safety and Efficacy).

RENOIR (NCT05035212) is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older. MATISSE (NCT04424316) is a global, randomized, double-blinded, placebo-controlled study designed to evaluate the efficacy, safety, and immunogenicity of RSVpreF against LRTD and severe LRTD due to RSV in infants born to healthy individuals vaccinated during pregnancy.

The efficacy and safety results of Renoir and Matisse were published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.