(Reuters) – The European Medicines Agency (EMA) on Wednesday backed GSK’s Arexvy vaccine for respiratory syncytial virus (RSV) in adults aged 60 years and older, putting Europe on track to approve the world’s first RSV vaccine.
The drugmaker is also expecting a decision from the U.S. Food And Drug Administration (FDA) by May to allow the use of its RSV vaccine in the United States, where 14,000 people die annually from the lower respiratory tract disease caused by the virus.
RSV is a common respiratory virus which produces symptoms similar to a cold, but can be fatal for young children and older adults. The disease surged in the U.S. and Europe this fall, alongside the flu and COVID-19.
Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, according to analysts.
Both drugmakers had gained the backing of a panel of FDA advisers in late February and early March, bringing them a step closer to approval in the United States.
The EMA’s recommendations are usually followed by the European Commission when it takes a final decision on drug approvals.
(Reporting by Prerna Bedi in Bengaluru; Editing by Shailesh Kuber)
