Moderna wins second product approval with RSV vaccine

By Eleanor Laise

First mRNA vaccine approved for a disease other than COVID

Moderna Inc.'s respiratory syncytial virus vaccine for older adults received U.S. regulatory approval, the company said Friday, marking the first time a messenger RNA vaccine has been approved for a disease other than COVID-19.

The Food and Drug Administration approved the mRNA shot, mResvia, for adults 60 and older, introducing fresh competition for RSV vaccines recently launched by GSK PLC and Pfizer Inc.

The FDA's decision gives Moderna a second approved product at a time when sales of its first product, the COVID-19 vaccine Spikevax, have been plummeting. The shot is expected to be available in time for the start of this fall's RSV season, Moderna said.

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.

Moderna is aiming to differentiate its RSV shot from the competition by offering single-dose, pre-filled syringes, which it says will save time and cut the risk of errors in administering the vaccine.

Friday's approval leaves time for the CDC's Advisory Committee on Immunization Practices to review the vaccine at its late June meeting. The green light comes after the FDA earlier delayed its decision on the shot, which was originally expected by May 12, citing administrative constraints.

GSK is already enjoying a big tailwind from the launch of its RSV vaccine, Arexvy. The drugmaker earlier this year boosted its long-term outlook for 2026-2031 based in part on the blockbuster launch of Arexvy.

Moderna's stock (MRNA) was down 3% Friday and has gained 47% in the year to date. Pfizer shares (PFE) gained 1% Friday, while GSK's American depositary receipts (GSK) gained 2%.

-Eleanor Laise

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05-31-24 1156ET

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