The FDA has approved Moderna’s RSV vaccine for older adults.
Courtesy: State-of-the-art
The Food and Drug Administration approved the decision on Friday State-of-the-art a vaccine against respiratory syncytial virus for adults aged 60 and over, which is the company’s second product introduced to the US market.
The decision is a victory for Moderna, which desperately needs another source of revenue amid falling demand for the Covid vaccine, its only commercially available product.
Approval of Moderna’s shot is based on trial at a tardy stage in older people, who are more susceptible to severe cases of RSV. According to data, the virus kills 6,000 to 10,000 seniors every year and causes 60,000 to 160,000 hospitalizations data from the Centers for Disease Control and Prevention.
Moderna’s shot will be sold under the mRESVIA brand. This is the first messenger RNA vaccine to be approved against a non-Covid disease. The company’s strain is also the only RSV vaccine available in a pre-filled syringe, designed to facilitate administration to the patient.
Some consultation panel to the CDC will vote in June on recommendations for the utilize and target population of the Moderna vaccine. The company expects the same recommendation from existing RSV shots GSK AND PfizerModerna executives said on a May 1 earnings call.
A positive recommendation from the CDC would enable Moderna’s vaccine to compete with GSK and Pfizer, which launched their vaccines in the US last fall. Pfizer’s vaccine has so far lagged behind GSK’s, but sales of both vaccines have so far reached hundreds of millions of units.
Moderna’s full-year 2024 sales forecast 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 combat a range of different diseases, including RSV, cancer and a highly contagious stomach disease called norovirus.
“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stéphane Bancel said in the release. “Through mRESVIA, we continue to support patients by eliminating global public health threats from infectious diseases.”
The biotechnology company currently has more than 40 products in development, several of which are in late-stage testing. These include a combination shot targeting Covid and flu that could gain approval as early as 2025.
Moderna also develops, among others: a stand-alone flu vaccine, a personalized cancer vaccine in collaboration with Merck, and vaccines for hidden viruses.
Moderna said it expects to return to sales growth in 2025 and break even by 2026 as it introduces recent products.
Investors have high hopes for the long-term potential of Moderna’s mRNA product portfolio: the company’s shares are up more than 60% this year after falling nearly 45% in 2023.
Data from vaccine trials
The FDA was initially scheduled to make a decision on the Moderna vaccine on May 12. The agency delayed approval, citing internal “administrative constraints.”
AND phase three trial in about 37,000 people showed that Moderna’s vaccine was 83.7% effective in preventing at least two symptoms of RSV after about three months. Novel data of that study conducted in February showed that the shot’s effectiveness dropped to 63% after 8.6 months.
Those results raised investor concerns at the time that the shot’s effectiveness was waning faster than those from GSK and Pfizer. Moderna w statement stated that comparisons cannot be made without direct shot tests.
The company added that the study included various populations, geographic locations and RSV case definitions, among other factors.
There were no significant safety concerns found in patients who received the shot in the study. Most side effects were delicate to moderate and included pain at the injection site, fatigue, headache, muscle pain and joint pain.
