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European Commission Approves Pfizer’s ABRYSVO

Pfizer Inc have announced that the European Commission (EC) has granted marketing authorisation for ABRYSVO, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both infants through maternal immunisation and older adults. ABRYSVO is indicated for:

“The approval of ABRYSVO in Europe marks significant progress in the scientific community's efforts to provide meaningful protection against RSV, a common respiratory virus that could potentially be severe and even life-threatening, especially for infants and older adults,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer. “Last year’s significant number of newborns, children, and adults being hospitalised across Europe demonstrated the immense need for protection against severe RSV cases. The approval of the vaccine for both older adults and infants through maternal immunisation is a triumph for public health and we hope to see a tremendous impact for future seasons.”

This marketing authorisation follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorisation 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 immunisation 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 authorisation includes single-dose use in this population as well.

The EU marketing authorisation for ABRYSVO is based on evidence from two Phase 3 clinical trials – RENOIR (RSV vaccine Efficacy study iN Older adults Immunised against RSV disease) and MATISSE (MATernal Immunisation Study for Safety and Efficacy).

RENOIR (NCT05035212) is a global, randomised, 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, randomised, 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.

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