PFE Secures EU Nod for Expanded Use of RSV Vaccine Abrysvo

Pfizer PFE announced that the European Commission (“EC”) has granted marketing authorization to expand the use of its RSV vaccine, Abrysvo. The vaccine has been approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 18-59 years.

This approval was expected as the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending the approval of Abrysvo in the above indication last month.

The EC and CHMP decisions are based on data from the phase III MONeT study, which evaluated the safety, tolerability and immunogenicity of Abrysvo in adults aged 18-59 at risk of RSV-associated disease due to certain chronic medical conditions. Data from this study showed that the immune response generated by the Pfizer vaccine was non-inferior to the responses seen in adults aged 60 or older, where vaccine efficacy is already demonstrated.

Following this latest approval, Abrysvo has become the first and only RSV vaccine approved for use in non-pregnant adults under 50 years of age in the EU. The vaccine was approved for a similar indication by the FDA in October, supported by data from the MONeT study.

Abrysvo is already approved in both the United States and the EU for the prevention of RSV-associated LRTD in older adults (aged 60 years and above) and in infants through maternal immunization.

PFE Stock Performance

Year to date, shares of Pfizer have lost nearly 8% against the industry’s 4% growth.

Abrysvo: A Key Revenue Driver for Pfizer

Abrysvo is one of Pfizer’s top-selling products since its initial approval in 2023. Though the vaccine’s sales declined 15% year-over-year to $755 million in 2024, the company is counting on its strong sales to drive top-line growth.

Sales of Abrysvo were impacted last year, mainly due to the revised recommendations for RSV vaccinations issued by the US Advisory Committee on Immunization Practices (ACIP) in June 2024. This committee recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease.

The approval for expanded use in adults aged 18 to 59 should boost vaccine sales going forward. It also gives Pfizer an edge over rivals GSK plc GSK and Moderna MRNA, each of which also markets its respective RSV vaccines.

GSK’s RSV vaccine, Arexvy, is approved for use in adults aged 50 years and older in the United States and the EU. This was also the first RSV vaccine to be approved anywhere in the world. GSK is currently conducting clinical studies on Arexvy for expanded use in adults aged 18 to 49 years.

Moderna, which markets its mRNA-based vaccine mResvia, is the newest entrant in the RSV vaccine space. This vaccine was approved last year by the FDA and EC to prevent RSV-LRTD in older adults aged 60 years and above. An FDA filing is currently under review, seeking expanded use of Moderna’s vaccine in high-risk adults aged 18-59 years. A final decision is expected by June 12, 2025. MRNA is also working on expanding the vaccine’s use in pediatric populations.

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PFE’s Zacks Ranks

Pfizer currently carries a Zacks Rank #3 (Hold). 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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