GSK’s respiratory syncytial virus (RSV) vaccine candidate has been recommended by the European Medicines Agency’s human medicines committee for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older.
There are currently no vaccines available to help protect older adults from RSV, a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease.
This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure.
Overall, RSV infections in older adults account for over 270,000 hospitalisations and approximately 20,000 in-hospital deaths each year in Europe.
The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) was based on results from GSK’s phase 3 AReSVi-006 trial, in which the vaccine showed 82.6% overall efficacy against RSV-LRTD in adults aged 60 years and older – the trial’s primary endpoint.
Positive vaccine efficacy was also observed in those with comorbidities of interest, such as certain cardiorespiratory and endocrino-metabolic conditions, underlining the potential impact of the candidate on populations most at risk of severe RSV outcomes.
The recommendation will now be referred to the European Commission, which is expected to deliver a final decision by July 2023.
The vaccine is also currently under regulatory review in the US and several other countries, the company said, with decisions expected this year.
GSK also announced positive phase 3 results last month for its five-in-one meningococcal vaccine candidate, MenABCWY, in healthy individuals aged ten to 25 years.
Five Neisseria meningitidis serogroups account for nearly all cases of invasive meningococcal disease – a uncommon illness that can cause life-threatening complications – but there are currently no approved vaccines that offer simultaneous protection against all of them.
It is hoped that GSK’s candidate, which targets all five of these serogroups, would provide the widest possible protection against the disease and lead to higher vaccine uptake.