First RSV vaccine for older adults is approved in Europe
BMJ 2023; 381 doi: https://doi.org/10.1136/bmj.p978 (Published 28 April 2023) Cite this as: BMJ 2023;381:p978
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 sign-off” for treatments already approved by trusted regulators in other parts of the world.2 The MHRA said that it could not comment on whether Arexvy would be considered along these lines.
The vaccine is also under regulatory review by the US Food and Drug Administration, and a decision is expected in May.
Trial findings
RSV is a common respiratory virus that usually causes mild cold-like symptoms but can be serious in vulnerable people including babies, older adults, and those with underlying conditions such as diabetes. The recombinant adjuvant vaccine, made by GSK, contains an engineered version of the RSV fusion surface glycoprotein. The protein is essential for RSV to infect the body and is the main target of the antibodies generated to fight the infection.
The positive opinion from the EMA’s committee for human medicines is based on data from a randomised, placebo controlled trial in 25 000 adults aged over 60 in 17 countries. The results showed that the vaccine was 82.6% effective in protecting against lower respiratory tract disease and 94.1% effective in protecting against severe lower disease associated with an RSV infection.3 The most common side effects reported were headache, tiredness, muscle pain, joint pain, and injection site pain.
The study is ongoing and will be used to evaluate the efficacy of a single vaccine dose over multiple seasons, the need for re-vaccination, and the vaccine’s safety profile. GSK is also carrying out a clinical trial that aims to expand the population who may benefit from RSV vaccine to adults aged 50-59, including those with underlying comorbidities, and results are expected this year.
Other vaccines
Andrew Pollard, director of the Oxford Vaccine Group, which is involved in research into RSV, told The BMJ, “RSV is a major contributor to winter pressures in the NHS, usually just prior to the influenza season, with up to 30 000 hospitalisations in infants every year in the UK. The virus also precipitates admissions among frail and elderly adults: the true figure is not certain, but some studies have suggested that the numbers are of a similar magnitude to influenza, at least in some seasons.
“The arrival of new vaccines for adults and interventions to protect babies—maternal vaccination in pregnancy or monoclonal antibodies given at birth—could significantly ease the impact of this virus in the years ahead.”
GSK’s RSV vaccine for older people looks likely to be the first to be approved, but others may not be far behind. Interim results from Pfizer’s ongoing phase 3 trial that were recently published in the New England Journal of Medicine showed a vaccine efficacy of 85.7%.4 Moderna has an mRNA vaccine candidate and in January said that it was submitting for regulatory approval, after the results of a placebo controlled study of 37 000 adults demonstrated efficacy of 83.7% against RSV lower respiratory tract disease.5
Last year the MHRA approved the monoclonal antibody nirsevimab to prevent RSV lower respiratory tract disease in newborns and infants during their first RSV season. A study published in the New England Journal of Medicine showed that a single injection of nirsevimab administered to babies before the RSV season was 74.5% effective at preventing medically attended RSV related lower respiratory tract infection and cut hospital admissions by two thirds.6
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