Moderna's RSV vaccine gets positive opinion from EU advisory panel

By Ciara Linnane

The vaccine has already won approval from the FDA

Moderna Inc.'s stock rose 1.5% early Friday, after the biotech said an advisory panel to the European Union's medical regulator had adopted a positive opinion on its respiratory syncytial virus (RSV) vaccine for adults aged 60 and older.

The vaccine, called mResvia, has already been approved by the U.S. Food and Drug Administration, becoming Moderna's second approved product after its COVID-19 vaccine, Spikevax.

"mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration, which can save healthcare professionals time and reduce administrative errors," Moderna (MRNA) Chief Executive Stéphane Bancel said in prepared remarks.

RSV often causes mild, cold-like symptoms, but can be severe, particularly for infants and older adults. About 60,000 to 160,000 people age 65 and older are hospitalized each year due to RSV, according to the Centers for Disease Control and Prevention.

The EU news comes after Moderna suffered a setback this week when advisers to the Centers for Disease Control and Prevention shifted their recommendations for who should be vaccinated against the illness.

The CDC's immunization advisory committee voted unanimously to recommend that everyone age 75 and older get a single dose of RSV vaccine. That replaces the advisers' previous recommendation that people 60 and older get the shot, if discussions between the patient and their doctor support that decision.

For people 60 to 74, the advisers voted unanimously to recommend the RSV vaccine only for those at increased risk of severe outcomes from the virus, which often causes mild symptoms similar to a cold but can more seriously affect babies and older adults.

Ahead of the meeting and vote, some investors were expecting the panel to recommend expanding the program to include people aged 50 to 59, which would have added millions of patients and boosted sales of vaccines. Pfizer Inc. (PFE) and GSK Plc also have RSV vaccines and GSK notched up the most sales during last year's season.

Moderna's stock also took a knock after a presentation to the advisory panel said its RSV shot was roughly 50% effective at the 18-month mark, raising concerns about its competitiveness against the GSK (GSK) (UK:GSK) and Pfizer vaccines.

GSK's vaccine, Arexvy, was 68% effective over 23.3 months in a clinical trial; and Pfizer Inc.'s Abrysvo was 78% effective after 16.4 months.

Moderna's stock has gained 22% in the year to date, outperforming the S&P 500 , which has gained 15%.

Eleanor Laise contributed to this article.

-Ciara Linnane

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06-28-24 0757ET

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