Pfizer's respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD).

The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old.

RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants and older adults.

In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year.

The EC's decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, was supported by positive results from the late-stage MATISSE and RENOIR trials.

In MATISSE, the vaccine demonstrated 81.8% efficacy in preventing severe medically attended lower respiratory tract illness in infants in the first 90 days after birth, and 69.4% efficacy within 180 days.

At an interim analysis of the ongoing RENOIR trial, the vaccine was 85.7% effective among older adults with two or more symptoms of RSV, and 66.7% for two or more symptoms.

Annaliesa Anderson, senior vice president and head of vaccine research and development at Pfizer, said the approval marked “significant progress in the scientific community's efforts to provide meaningful protection against RSV”.

She continued: “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.”

The approval comes just days after Abrysvo was approved by the US Food and Drug Administration to protect infants through the active immunisation of pregnant individuals. The regulator approved the vaccine for use in adults aged 60 years and older earlier this year.

The EC has also previously approved GSK’s vaccine Arexvy to protect older adults, and AstraZeneca and Sanofi’s long-acting antibody therapy Beyfortus (nirsevimab) to protect infants during their first RSV season.

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