The respiratory syncytial virus (RSV), which results in tens of thousands of hospital admissions and fatalities each year, has finally received approval from European regulatory authorities.
The Arexvy injection, manufactured by British pharmaceutical company GSK (GSK.L), is intended to safeguard individuals 60 and older.
RSV normally manifests as cold-like symptoms, but in young children and the elderly, it is a major contributor to pneumonia.
The complex molecular structure of the virus and safety concerns with previous vaccine attempts had stymied efforts to successfully develop a shot since the virus was first discovered in 1956.
About a month after the U.S. health agency granted Arexvy the green light, the European Commission on Wednesday decided to approve it. This approval follows a recent support from the European Medicines Agency.
The availability of the vaccine in Europe will depend on national recommendations and reimbursement discussions, but the first launches are expected this autumn ahead of the 2023/2024 RSV season, GSK said on Wednesday.
GSK, one of the world’s biggest vaccine makers, is relying in part on Arexvy to drive long-term growth, with the pending loss of patent protection for a key HIV compound and setbacks in its marketed oncology portfolio.
A similar shot from rivals Pfizer (PFE.N), Abrysvo, was also given the thumbs-up by the US Food and Drug Administration last week.
A direct comparison of efficacy between the GSK and Pfizer studies is difficult due to the disparate definitions of the study endpoints.
The two companies are competing for a slice of an estimated $13 billion global market for RSV vaccines, according to modelling from Jefferies analyst Peter Welford, who in a note last month predicted Arexvy would ultimately rake in $4 billion in peak global sales.
TD Cowen analyst Steve Scala stated last month that GSK could eventually capture more than half of the adult RSV market, despite the fact that Pfizer will be a fierce opponent.
Each year, RSV causes over 20,000 in-hospital fatalities in persons over 60 and over 270,000 hospitalisations in Europe.