The Food and Drug Administration recently approved Moderna’s vaccine for respiratory syncytial virus for adults ages 60 and above, marking the company’s second product to enter the U.S. market. This approval comes as a win for Moderna, providing them with another revenue source amidst decreasing demand for their Covid jab.
Moderna’s shot approval was based on a late-stage trial focusing on older adults, who are more susceptible to severe cases of RSV. This virus is responsible for the deaths of 6,000 to 10,000 seniors annually and leads to 60,000 to 160,000 hospitalizations as per data from the Centers for Disease Control and Prevention. Marketed as mRESVIA, this mRNA vaccine is the first of its kind to receive approval for a disease other than Covid. Additionally, it is the sole RSV vaccine available in a pre-filled syringe, simplifying the administration process for patients.
Competition and Revenue Growth
An advisory panel to the CDC is expected to vote on recommendations for the use and targeted population of Moderna’s vaccine in June. The company anticipates a positive response, allowing them to compete with existing RSV vaccines from GSK and Pfizer. With a projected full-year sales guidance of approximately $4 billion for 2024, Moderna’s revenue forecast includes income from its RSV vaccine.
Expanding mRNA Technology
Moderna’s mRNA platform has showcased its versatility beyond Covid treatment, addressing a variety of diseases such as RSV, cancer, and even norovirus. With over 40 products in development, including a combination shot for Covid and the flu, the company is aiming for approval as early as 2025. Collaborations with Merck for a personalized cancer vaccine and the development of shots for latent viruses reflect Moderna’s commitment to innovation.
Investors are optimistic about the potential of Moderna’s mRNA product pipeline, leading to a more than 40% increase in the company’s shares this year. Despite a drop of nearly 45% in 2023, Moderna is working towards returning to sales growth by 2025 and breaking even by 2026 with the launch of new products.
A phase three trial involving approximately 37,000 individuals revealed that Moderna’s vaccine was 83.7% effective at preventing at least two symptoms of RSV after around three months. Subsequent data in February showed a decrease in efficacy to 63% at 8.6 months. Concerns arose regarding the diminishing efficacy compared to GSK and Pfizer shots. Moderna defended the results by highlighting differences in study populations, geographic locations, and case definitions for RSV.
The trial did not identify any significant safety concerns among patients receiving the vaccine. Moderna’s approval for the RSV vaccine signifies a significant achievement, showcasing the potential of their mRNA platform in combating infectious diseases on a global scale.
Overall, Moderna’s success with the approval of their RSV vaccine highlights their commitment to innovation and addressing public health needs. As the company continues to expand its product portfolio and collaborations, the future looks promising for Moderna in the pharmaceutical landscape.