The Food and Drug Administration has given its approval for Moderna's vaccine for respiratory syncytial virus for adults aged 60 and older. This marks the company's second product to enter the U.S. market, providing Moderna with a much-needed revenue stream as demand for its Covid jab declines.
The decision to approve Moderna's shot was based on a late-stage trial involving older adults, who are more susceptible to severe cases of RSV. This virus is responsible for the deaths of between 6,000 and 10,000 seniors annually, leading to 60,000 to 160,000 hospitalizations. Marketed under the brand name mRESVIA, Moderna's vaccine is the first messenger RNA vaccine to be approved for a disease other than Covid. It is also the only RSV vaccine available in a pre-filled syringe, designed to simplify the administration process for patients.
An advisory panel to the CDC is scheduled to vote in June on recommendations regarding the use and target population for Moderna's vaccine. The company anticipates receiving a favorable recommendation, allowing its vaccine to compete with those from GSK and Pfizer, both of which were launched in the U.S. in the previous fall. Moderna has set a sales guidance of around $4 billion for the full year 2024, including revenue from its RSV vaccine.
The approval of Moderna's second product showcases the versatility of its messenger RNA platform beyond addressing the Covid pandemic. The biotech company is utilizing this technology to combat various diseases such as RSV, cancer, and norovirus, a highly transmissible stomach bug. Moderna has an extensive pipeline of over 40 products in development, with many undergoing late-stage trials. These include a combination shot for Covid and the flu, a stand-alone flu vaccine, a personalized cancer vaccine in collaboration with Merck, and vaccines for latent viruses.
Investors have high expectations for Moderna's mRNA product pipeline, leading to a significant increase in the company's shares this year. Moderna is aiming to return to sales growth in 2025 and achieve break-even status by 2026 with the launch of new products. The company's long-term success hinges on the approval and commercialization of these innovative treatments.
During the approval process, concerns were raised about the efficacy of Moderna's vaccine, especially in comparison to those from GSK and Pfizer. The company addressed these concerns by highlighting the differences in study populations, geographic locations, and case definitions for RSV between the trials. Moderna emphasized that direct comparisons can only be made through head-to-head trials and reiterated that no significant safety issues were identified during the study.
Moderna's approval for the RSV vaccine represents a significant milestone for the company, showcasing the potential of its mRNA platform beyond Covid. With a diverse pipeline of products in development and a promising outlook, Moderna is poised to make a lasting impact on global public health.