EMA adopts 'positive opinion' of GSK's RSV vaccine candidate

The FTSE 100 pharmaceuticals company said the CHMP was recommending the vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.

It said it was the first time an RSV vaccine candidate for adults had gained a positive opinion, which it said was “one of the final steps” in the marketing authorisation procedure prior to approval by the European Commission.

RSV currently has no vaccines or specific treatments available for older adults.

In Europe, the virus causes more than 270,000 hospitalisations, and around 20,000 in-hospital deaths in adults aged 60 years and older each year.

GSK said its vaccine candidate had the potential to be the first vaccine available to help protect older adults from RSV disease.

The firm’s marketing authorisation application for the vaccine candidate was reviewed under accelerated assessment, which applies to products determined by the CHMP to be of major interest for public health and therapeutic innovation.

A final decision from the European Commission was expected by July.

The positive opinion was supported by data from a pivotal phase-three vaccine efficacy trial, in which the vaccine candidate showed 82.6% overall efficacy against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint.

Efficacy was 94.6% in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrino-metabolic conditions.

The vaccine was generally well-tolerated, GSK said, with an acceptable safety profile.

GSK's RSV older adult vaccine candidate was also under regulatory review by the US Food and Drug Administration (FDA), Japan's Ministry of Health, Labour and Welfare, and several other regulatory agencies, with decisions expected in 2023.

Additional regulatory submissions would continue throughout this year, the board confirmed.

“GSK's RSV older adult vaccine candidate contains a recombinant subunit RSV prefusion F glycoprotein antigen - ‘RSVPreF3’ - combined with the company's proprietary ‘AS01E’ adjuvant,” the company explained in its statement.

“Across multiple trials, the vaccine candidate was generally well tolerated, with an acceptable safety profile.”

It said the most frequently-observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia, which were typically mild-to-moderate, and transient.

“A clinical trial that aims to expand the population who may benefit from RSV vaccination into adults aged 50 to 59, including participants with underlying comorbidities, is fully recruited.

“Results are expected in 2023, together with additional results from the AReSVi-006 phase III efficacy trial and the AReSVi-004 immunogenicity trial.

“These trials continue to evaluate an annual revaccination schedule and protection/immunogenicity over multiple seasons following one dose of the RSV vaccine candidate.”

At 0803 BST, shares in GSK were up 0.83% at 1,453.07p.

Reporting by Josh White for Sharecast.com.