Moderna said Friday that the Food and Drug Administration has approved its vaccine for respiratory syncytial virus, or RSV, for older adults, making it the Cambridge biotech’s second licensed product.
Like Moderna’s vaccine for COVID-19, which was authorized for emergency use by the FDA in December 2020 and fully approved 13 months later, the RSV vaccine uses messenger RNA technology to stimulate immunity. The new vaccine is called mResvia and is for adults aged 60 years and older.
People that age are among those most at risk for serious illness from RSV infection, a common seasonal virus. Each year, roughly 60,000 to 160,000 older adults in the United States are hospitalized and 6,000 to 10,000 die as a result of the illness, according to the US Centers for Disease Control and Prevention.
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The approval was welcome news for Moderna, which has desperately needed a money-making follow-up to its COVID vaccine, Spikevax.
On May 2, the company reported that first-quarter sales of Spikevax plummeted 91 percent from a year earlier, from $1.9 billion to $167 million. The plunge was a dramatic illustration of waning demand for vaccines that protect people from the coronavirus that caused a global pandemic.
Stéphane Bancel, Moderna’s chief executive, said in a statement that mResvia’s approval “builds on the strength and versatility of our mRNA platform.”
“This approval is also the first time that an mRNA vaccine has been approved for a disease other than COVID-19,” he said.
In May of last year, the FDA approved the first two vaccines for RSV for older people — Arexvy, from GSK, and Abrysvo, from Pfizer. Neither of those vaccines use mRNA to stimulate immunity.
In a late-stage trial of mResvia involving nearly 37,000 older people in 22 countries, the vaccine was found to have efficacy of 83.7 percent against lower respiratory tract disease caused by RSV. Moderna said that a follow-up analysis showed that protection lasted for a median of 8.6 months.
Moderna said the vaccine should be available for the respiratory virus season that is expected to begin in late 2024 and extend into 2025. Of the three approved RSV vaccines, mResvia is the only one available in a pre-filled syringe, which saves time when administering the shot, Moderna added.
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Joseph Stringer, an analyst at Needham, said in a note to investors that he expects Moderna to capture roughly a third of the worldwide market for RSV vaccines. He estimated that Moderna’s shot will generate $320 million in sales this year and reach peak sales of about $3.2 billion in 2034, assuming it is also approved for infants.
The GSK and Pfizer vaccines have each generated more than $1 billion in sales since they were approved a year ago, he said.
RSV usually causes mild, cold-like symptoms, and most people recover in a week or two, according to the CDC, but it can be serious. Infants and older adults are more likely to develop severe RSV and need hospitalization.
Once an obscure biotech in Kendall Square, Moderna became the largest Massachusetts-based drug maker by head count, with more than 4,000 employees, after the US government spent billions of dollars for doses of its COVID vaccine. The government also paid Pfizer billions for its mRNA vaccine against COVID, which was cleared a week before Moderna’s.
Moderna is nearing another deal with the US government, in this case to fund a late-stage trial of its experimental bird flu vaccine, the Financial Times reported Thursday. Millions of dollars from the federal Biomedical Advanced Research and Development Authority could come as soon as June, according to the report. Moderna said its experimental vaccine appears to protect people from the bird flu variant that is circulating in the United States right now.
Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.