EMA Accepts GSK's Filing for Expanded Use of RSV Vaccine Arexvy

GSK plc GSK announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, for use in adults aged 18 years and above.

With the EMA accepting the application for review, a final decision from the regulatory body in Europe is expected in the first half of 2026.

Arexvy is currently approved for the prevention of lower respiratory tract disease (“LRTD”) caused by RSV in all individuals aged 60 years and above, as well as for high-risk individuals aged 50-59 years.

GSK is currently seeking approval for the expanded use of Arexvy in adults aged 18 years and above in the United States and Japan.

Year to date, shares of GSK have risen 20.8% against the industry’s decline of 0.6%.

GSK's Arexvy Sales Remain Lukewarm

Arexvy was the first RSV vaccine for older adults to be approved anywhere in the world.

However, sales of the vaccine have been lukewarm, mainly due to the revised recommendations for RSV vaccinations issued by the Advisory Committee on Immunization Practices (“ACIP”) in June 2024.

In June, the ACIP recommended the use of Arexvy for all adults aged 75 years and above. However, for adults aged 60-74 years, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease.

Arexvy generated sales worth £78 million in the first quarter of 2025, down 57% year over year due to lower demand in the United States.

Other RSV Vaccine Makers in the Market

Pfizer’s PFE Abrysvo is approved for the prevention of RSV-associated LRTD in all individuals aged 60 years and above, as well as in infants, through maternal immunization.

PFE’s Abrysvo is also approved for use in high-risk adults aged 18-59 years in the United States and Europe.

Earlier this year, the ACIP recommended the expanded use of Arexvy and Abrysvo for use in adults aged 50-59 years who are at high risk for severe RSV disease. The updated ACIP recommendation lowers the recommended age for RSV vaccination from 60 years to 50 years for high-risk adults.

The ACIP’s recommendation is pending final approval by the director of the U.S. Centers for Disease Control and Prevention (“CDC”) and the Department of Health and Human Services.

Moderna’s MRNA RSV vaccine, mResvia, was approved last year by the FDA and the European Commission to prevent RSV-LRTD in older adults aged 60 years and above.

Last week, the FDA approved MRNA’s mResvia for use in high-risk adults aged 18-59 years. Moderna is also working on expanding the vaccine’s use in pediatric populations.

We note that RSV vaccine sales have been weak across the industry for the 2024-2025 vaccination season due to the restrictive recommendation issued by the U.S. CDC last year for individuals in the 60-74 age bracket.

mResvia generated sales worth $2 million during the first quarter of 2025, while sales of Pfizer’s RSV vaccine, Abrysvo, fell 9% year over year to $131 million.

GSK's Zacks Rank

GSK currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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