Pfizer’s RSV vaccine receives EC approval to protect infants and older adults

The decision follows a recent recommendation from the European Medicines Agency’s human medicines committee

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 32 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.

The approval, 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.”