European Commission approves Pfizer's RSV vaccine

The European Commission approved Pfizer's PFE.N respiratory syncytial virus vaccine for the prevention of lower respiratory tract disease caused by RSV in adults aged 18 to 59 at increased risk of the disease, the company said on Tuesday.

The expanded EU approval, applicable in all 27 countries of the bloc, is for Pfizer's Abrysvo vaccine, which was backed by the European Medicines Agency's panel of experts in March.

It is a blow for rival drugmaker GSK which has not yet won approval for this population for its RSV vaccine.

RSV is a common virus that can be deadly and is most dangerous for the very young and the elderly.

U.S. drugmaker Pfizer and the UK's GSK are each banking on strong sales of their RSV shots, which they launched in the United States in 2023, as they both face generic competition for their top-selling medicines later this decade.

Both companies hit hurdles in that effort. Sales of both shots were down significantly in the U.S., the biggest market for the pharma industry, during the second autumn vaccination season since the companies launched the shots there.

But in Europe, Pfizer scored a win last year when the British government selected it over UK-headquartered GSK to supply around 5 million doses of its vaccine to older adults and pregnant mothers to protect their babies in England and Northern Ireland over the following two years.

The UK Health and Security Agency last week published early data from the roll out in 2024 of Pfizer's vaccine in England, showing that the shot is making a significant reduction to hospital admission rates in older people so far.

Such real-world data can be useful for other European countries considering introducing the RSV vaccine into their own national immunisation programmes.

Pfizer's vaccine is currently included in four national immunisation programmes for older adults in the EU, a company spokesperson said on Tuesday.