EC approves Pfizer’s ABRYSVO RSV vaccine for infants and older adults

Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for ABRYSVO, its bivalent respiratory syncytial virus (RSV) prefusion F vaccine. This groundbreaking vaccine aims to protect infants through maternal immunization and individuals 60 years and older against lower respiratory tract disease (LRTD) caused by RSV.

ABRYSVO Offers Dual Protection Against Severe RSV Cases

Annaliesa Anderson, Senior Vice President and Head of Vaccine Research and Development at Pfizer, remarked, “The approval of ABRYSVO is a public health triumph, offering meaningful protection against RSV, a potentially severe respiratory virus, especially for vulnerable populations like infants and older adults.” The vaccine’s approval comes after the European Union witnessed a significant number of hospitalizations due to severe RSV cases in infants, children, and adults across member states last year.

Pfizer gains EC approval for ABRYSVO RSV vaccine for infants and older adults. Photo courtesy of Pfizer Inc.

Marketing Authorization Based on Robust Clinical Trials

The EC’s authorization is supported by data from two pivotal Phase 3 clinical trials, RENOIR and MATISSE. Both trials were designed to evaluate the vaccine’s efficacy, safety, and immunogenicity in the targeted age groups. ABRYSVO is the first licensed RSV vaccine explicitly designed for maternal immunization, allowing for a single dose to be administered between weeks 24 and 36 of gestation. It has also been studied for single-dose use in adults 60 years and older.

ABRYSVO to Roll Out in 30 European Countries

This marketing authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The decision by the EC follows a recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

As RSV continues to pose a significant health risk, especially to infants and older adults, the European Commission’s approval of ABRYSVO is a critical step forward in safeguarding public health. The approval allows for the broad administration of the vaccine, which is expected to have a substantial impact on reducing severe cases of RSV in these vulnerable populations.