FDA approves Moderna RSV vaccine for seniors

The Food and Drug Administration approved Friday by Moderna respiratory syncytial virus vaccine for adults ages 60 and older, the company’s second product to enter the U.S. market.

The move is a victory for Moderna, which desperately needs another revenue stream amid plummeting demand for its Covid vaccine, its only commercially available product.

Approval of Moderna’s vaccine is based on a late-stage trial in older people, who are more vulnerable to severe cases of RSV. The virus kills between 6,000 and 10,000 elderly people each year and causes between 60,000 and 160,000 hospitalizations, according to data from the Centers for Disease Control and Prevention.

A CDC advisory committee will vote in June on recommendations for the use and intended population of the Moderna vaccine. The company expects a recommendation equal to existing RSV injections of GSK And PfizerModerna executives said during a May 1 earnings conference call.

A positive recommendation from the CDC would allow Moderna’s vaccine to compete with GSK and Pfizer, which launched their respective vaccines in the United States last fall. Pfizer’s vaccine is so far lagging behind GSK’s, but both vaccines have so far recorded hundreds of millions in sales.

Moderna’s full-year 2024 sales forecast of about $4 billion includes revenue from its RSV vaccine.

The approval demonstrates the versatility of Moderna’s messenger RNA platform beyond the treatment of Covid. The biotech company uses this technology to combat a range of different diseases, including RSV, cancer and a highly contagious stomach bug known as norovirus.

The biotechnology company currently has more than 40 products in development, several of which are in late-stage testing. They include its combined shot targeting Covid and flu, which could be approved as early as 2025.

Moderna is also developing a standalone flu vaccine, a personalized cancer vaccine with Merck, and latent virus vaccines, among other products.

Moderna said it plans to return to sales growth in 2025 and break even by 2026, with the launch of new products.

Investors have high hopes for the long-term potential of Moderna’s mRNA product pipeline: the company’s shares are up more than 60% this year after falling nearly 45% in 2023.

The FDA was originally scheduled to make a decision on Moderna’s vaccine on May 12. The agency delayed approval, citing internal “administrative constraints.”

A phase three trial of about 37,000 people showed Moderna’s vaccine was 83.7% effective in preventing at least two symptoms of RSV after about three months. New data from that study released in February showed the vaccine’s effectiveness declined to 63% after 8.6 months.

At the time, these results caused investors to worry that the vaccine’s effectiveness would decline more quickly than that of GSK and Pfizer’s vaccines. Moderna said in a statement that comparisons cannot be made without head-to-head trials of the shots.

The company added that its trial had, among other differences, study populations, geographic locations and case definitions for RSV.

No significant safety concerns were identified in patients who received the vaccine during the trial. Most side effects were mild to moderate and included pain at the injection site, fatigue, headache, muscle pain, and joint pain.