First RSV vaccine for older adults is approved in Europe

The European Medicines Agency (EMA) has recommended a marketing authorisation for Arexvy, the first vaccine to protect people aged over 60 against respiratory syncytial virus (RSV) infection.1

Arexvy was evaluated under the EMA’s accelerated assessment mechanism for products determined to be of major public health interest. In Europe RSV causes an estimated 250 000 hospital admissions and 17 000 deaths in hospital every year in people over 65. The EMA’s recommendations are usually followed by the European Commission, and a final decision is expected by July.

GSK, which makes Arexvy, has said that it plans to submit a marketing authorisation application shortly to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). In March the UK government announced that it would fast track patient access to innovative drugs and technologies, with the MHRA given “near automatic …