The FDA has approved Moderna’s respiratory syncytial virus vaccine for older adults.
Provided by: Moderna
The Food and Drug Administration on Friday Moderna The RSV vaccine is for adults aged 60 and older and is the company’s second product to be introduced to the U.S. market.
The decision is a win for Moderna, which is in desperate need of new revenue streams as demand for its only commercially available product, a COVID-19 vaccine, plummets.
The approval of Moderna’s vaccine was based on late-stage clinical trials in older adults, who are more susceptible to severe RSV infection, which kills between 6,000 and 10,000 older adults each year and causes between 60,000 and 160,000 hospitalizations, according to data from the Centers for Disease Control and Prevention.
Moderna’s vaccine will be sold under the brand name “mRESVIA.” It is the first messenger RNA vaccine approved for a disease other than COVID-19. It is also the only RSV vaccine delivered in a prefilled syringe designed for ease of administration to patients.
A CDC advisory committee is scheduled to vote in June on recommendations for use of the Moderna vaccine and who should use it. The company is expected to make recommendations similar to those for existing RSV vaccines. GSK and PfizerA Moderna executive said this during an earnings call on May 1.
A positive recommendation from the CDC would put Moderna’s vaccine in a position to compete with GSK and Pfizer, which launched their respective vaccines in the U.S. last fall. While the Pfizer vaccine has so far lagged behind GSK’s, both companies have sold hundreds of millions of doses of their vaccines to date.
Moderna’s full-year 2024 sales outlook of about $4 billion includes revenue from its respiratory syncytial virus vaccine.
The approval demonstrates the versatility of Moderna’s messenger RNA platform beyond treating COVID-19: the biotech company is using the technology to treat a variety of illnesses, including respiratory syncytial virus, cancer and the highly contagious gastroenteritis known as norovirus.
“The FDA approval of our second product, mRESVIA, further reinforces the strength and versatility of our mRNA platform,” Moderna CEO Stéphane Bancel said in the release. “With mRESVIA, we continue to address global public health threats related to infectious diseases and serve patients.”
The biotech company currently has more than 40 products in development, several in late-stage testing, including a combination vaccine targeting COVID-19 and influenza that could be approved as soon as 2025.
Moderna is also developing a standalone influenza vaccine, a personalized cancer vaccine in collaboration with Merck, and a vaccine against latent viruses.
Moderna said it expects to return to sales growth in 2025 and reach breakeven by 2026 thanks to new product launches.
Investors have high hopes for the long-term potential of Moderna’s mRNA product pipeline, with the company’s shares up more than 60% this year after falling nearly 45% in 2023.
Vaccine Trial Data
The FDA was originally scheduled to make a decision on Moderna’s vaccine on May 12. The agency delayed its approval, citing internal “administrative constraints.”
A Phase 3 trial of about 37,000 people showed that Moderna’s vaccine was 83.7% effective in preventing at least two symptoms of RSV in about three months. New data from the study in February showed that the vaccine’s effectiveness dropped to 63% at 8.6 months.
At the time, those results raised concerns among investors that the vaccine’s efficacy might wane more quickly than those from GSK and Pfizer Inc. Moderna said in a statement that no comparison could be made without head-to-head trials of the vaccines.
The company added that the trials had differences in study populations, geographic locations and case definitions for RSV infection.
No serious safety concerns were identified in patients who received the shot in the trial, and most side effects were mild to moderate and included pain at the injection site, fatigue, headache, and muscle or joint pain.
