The US Food and Drug Administration (FDA) has approved the Moderna RSV vaccine for seniors.
Courtesy: Moderna
The Food and Drug Administration approved it on Friday Moderna The respiratory syncytial virus vaccine for adults ages 60 and older is the company's second product to enter the U.S. market.
The decision is a win for Moderna, which desperately needs another source of income amid falling demand for its Covid vaccine, its only commercially available product.
Approval of the Moderna vaccine is based on a late-stage trial in older adults, who are more vulnerable to severe cases of respiratory syncytial virus. The virus kills 6,000 to 10,000 seniors each year and causes 60,000 to 160,000 to be hospitalized, according to data from the Centers for Disease Control and Prevention.
The Moderna dose will be marketed under the brand name mRESVIA. It is the first messenger RNA vaccine to be approved for a disease other than Covid. The company's vaccine is also the only RSV vaccine available in a prefilled syringe, which is designed to make it easier for patients to administer.
A Centers for Disease Control and Prevention advisory committee will vote in June on recommendations for use and target numbers of the Moderna vaccine. The company expects equal recommendation for existing RSV shots from it GlaxoSmithKline And PfizerThat's what Moderna executives said during a May 1 earnings call.
A positive recommendation from the CDC would allow the Moderna vaccine to compete with GlaxoSmithKline and Pfizer, which launched their doses in the United States last fall. Pfizer's vaccine has so far lagged behind GlaxoSmithKline's, but both doses have so far recorded sales in the hundreds of millions.
Moderna's full-year 2024 sales guidance of about $4 billion includes revenue from the RSV vaccine.
The approval demonstrates the versatility of Moderna's messenger RNA platform beyond Covid treatment. The biotech company is using the technology to treat a range of different diseases, including respiratory syncytial virus (RSV), cancer, and a highly contagious stomach bug known as norovirus.
“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stephane Bancel said in a statement. “With mRESVIA, we continue to serve patients by addressing global public health threats related to infectious diseases.”
The biotechnology company currently has more than 40 products in development, many of which are in late-stage trials. They include combination shots targeting Covid and influenza, which could receive approval as early as 2025.
Moderna is also developing a standalone influenza vaccine, a personalized cancer vaccine in collaboration with Merck, and latent virus shots, among other products.
Moderna said it expects 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 pipeline of mRNA products: The company's shares are up more than 60% this year after falling nearly 45% in 2023.
Vaccine trial data
The Food and Drug Administration was initially scheduled to make a decision on the Moderna vaccine on May 12. But the agency delayed approval, citing internal “administrative restrictions.”
A phase 3 trial in nearly 37,000 people showed that the Moderna vaccine was 83.7% effective in preventing at least two symptoms of respiratory syncytial virus in about three months. New data from that study in February showed that the vaccine's effectiveness dropped to 63% in 8.6 months.
At the time, those results raised concerns among investors that the vaccine's effectiveness was declining faster than that of GlaxoSmithKline and Pfizer's shots. Moderna said in a statement that comparisons cannot be made without conducting direct trials on doses.
The company added that its trial included different study populations, geographic locations, and case definitions for RSV, among other differences.
No major safety concerns were identified in patients who received the shot in the trial. Most side effects were mild to moderate and included pain at the injection site, fatigue, headache, muscle aches, and joint pain.
