EMA has recommended a marketing authorisation in the European Union for Arexvy (recombinant, adjuvanted), the first vaccine for active immunisation to protect adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).
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RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover within one to two weeks, but RSV can be serious in vulnerable people, including older adults and those with lung or heart disease and diabetes.
In Europe, RSV causes an estimated 250,000 hospitalisations and 17,000 in-hospital deaths every year in people aged 65 years and older.
Arexvy contains an engineered version of the RSV fusion surface glycoprotein. This protein is essential for RSV to infect the body and is also the main target of the antibodies generated to fight the infection.
The vaccine also contains an ‘adjuvant’, a substance to help strengthen the immune response to the vaccine. When a person is given the vaccine, their immune system generates specific antibodies and T cells that help prevent RSV infection.
Arexvy was evaluated under EMA's accelerated assessment mechanism because prevention of RSV infection in the elderly population is considered to be of major public health interest.
The opinion by EMA’s committee for human medicines (CHMP) is based on data from a randomised, placebo-controlled trial in 25,000 adults in 17 countries. The results showed an estimated 83% protection against RSV-confirmed LRTD for at least six months.
The most common side effects reported were headache, tiredness, muscle pain, joint pain and injection site pain.
The study is still ongoing and will be used to evaluate the efficacy of a single dose of Arexvy over multiple seasons and the need for re-vaccination, and to monitor its safety profile.
The opinion adopted by the CHMP is an intermediary step on Arexvy’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.
Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country. ■