The European Commission (EC) has expanded the approval of Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, to include adults aged 18 to 59 years at increased risk of lower respiratory tract disease caused by RSV.
This decision builds on the vaccine’s initial authorisation for individuals aged 60 and older, which was granted in August 2023. The expanded EU approval follows a recommendation from the European Medicines Agency’s (EMA’s) expert panel last month.
Go deeper with GlobalData
It also aligns with regulatory progress in the US, where the US Food and Drug Administration (FDA) approved Abrysvo for the same 18-to-59-year-old high-risk group in October 2024, after previously approving it for older adults in May 2023.
The approval represents another step forward for Pfizer in the RSV vaccine market, where it competes with GSK’s Arexvy. While GSK has secured approval for older adults, it has not yet gained authorisation for the younger high-risk population. This regulatory delay could give Pfizer an advantage as the two companies compete for market share.
Despite these developments, sales of both Pfizer and GSK’s RSV vaccines declined significantly in the last quarter of 2024, reflecting lower demand in the US. Pfizer reported a 62% year-over-year drop in Abrysvo sales for Q4, citing reduced vaccination rates after changes in US guidelines. GSK saw an even steeper decline of 69% for Arexvy, attributing it to a more limited recommendation for adults aged 60 to 74 and inventory consumption.
RSV is a common virus that can cause severe respiratory illness, particularly in infants, older adults, and those with underlying health conditions. It is the leading cause of lower respiratory tract disease, which can result in pneumonia and hospitalisation.
In the UK, early real-world data suggest that Pfizer’s vaccine is having a positive impact. The UK Health Security Agency (UKHSA) recently reported that England’s RSV vaccination programme, which launched in September 2024, has already led to a 30% reduction in hospital admissions among 75 to 79-year-olds. The rollout covers older adults as well as pregnant women, and the impact is expected to grow as uptake increases.
In 2024, Pfizer secured a major win over GSK in the UK when it was chosen to supply around five million doses of its RSV vaccine for older adults and pregnant mothers in England and Northern Ireland over two years.
While long-term sales projections still favour GSK, with GlobalData estimating Arexvy will generate $2.4bn in revenue by 2030, compared to $1.5bn for Abrysvo, Pfizer’s latest regulatory success and early real-world data could help it gain momentum in Europe.
GlobalData is the parent company of Pharmaceutical Technology.
