The Food and Drug Administration has given its approval for Moderna’s vaccine for respiratory syncytial virus (RSV) aimed at adults who are 60 years and older. This marks the second product from Moderna to enter the U.S. market. The approval comes at a crucial time for Moderna, as the demand for its Covid vaccine has been declining significantly. The decision to approve Moderna’s shot was based on a late-stage trial focusing on older adults, who are more susceptible to severe cases of RSV. RSV is a virus that causes the death of 6,000 to 10,000 seniors annually and results in 60,000 to 160,000 hospitalizations, according to data from the Centers for Disease Control and Prevention.
Moderna’s RSV vaccine is set to be marketed under the brand name mRESVIA. It is a messenger RNA (mRNA) vaccine that stands out as the first of its kind to receive approval for a disease other than Covid. What’s more, Moderna’s shot will be the only RSV vaccine available in a pre-filled syringe, making it more convenient for healthcare providers to administer to patients. The CDC’s advisory panel is expected to vote on recommendations for the usage and target population of Moderna’s vaccine in June. Moderna’s executives anticipate a positive recommendation, positioning their vaccine to compete with those from GSK and Pfizer, which were launched in the U.S. in the previous fall.
Both GSK and Pfizer have seen significant sales figures from their RSV shots, with Moderna projecting its full-year 2024 sales to reach approximately $4 billion, including revenue from its newly approved RSV vaccine. This approval highlights the versatility of Moderna’s mRNA platform in addressing various diseases beyond just Covid. Moderna has expressed its commitment to utilizing mRNA technology to combat a range of health threats, including RSV, cancer, and norovirus. CEO Stéphane Bancel emphasized how mRESVIA demonstrates the strength and adaptability of Moderna’s mRNA platform.
Moderna currently has an extensive pipeline of over 40 products in development, with several in late-stage trials. These products include a combination shot for Covid and the flu, a stand-alone flu vaccine, a personalized cancer vaccine in partnership with Merck, and treatments for latent viruses. The company foresees a return to sales growth in 2025 and aims to break even by 2026 through the launch of these new products. Investors have shown optimism in the long-term potential of Moderna’s mRNA product line, resulting in a significant rise in the company’s shares this year.
Overall, the approval of Moderna’s vaccine for RSV represents a significant milestone for the company, showcasing its commitment to leveraging mRNA technology to address a wide range of health concerns. The positive reception from the FDA underscores the potential impact of Moderna’s innovative approach to developing vaccines and treatments for various infectious diseases.
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