In a recent announcement, the Food and Drug Administration (FDA) has approved Moderna’s vaccine for respiratory syncytial virus (RSV) for adults aged 60 and above. This marks the company’s second product to enter the U.S. market, providing them with a much-needed revenue source amidst declining demand for their Covid jab.
The decision to approve Moderna’s shot is based on a late-stage trial conducted on older adults, who are more susceptible to severe cases of RSV. RSV is known to cause between 6,000 and 10,000 deaths in seniors annually, leading to 60,000 to 160,000 hospitalizations. Moderna’s vaccine, marketed under the brand name mRESVIA, is the first messenger RNA vaccine to gain approval for a disease other than Covid. It is also unique in that it is available in a pre-filled syringe, making it easier for healthcare providers to administer.
Following the FDA approval, an advisory panel to the Centers for Disease Control and Prevention (CDC) is set to vote on recommendations for the use and intended population of Moderna’s vaccine in June. Moderna executives are optimistic about receiving a favorable recommendation, allowing their product to compete with shots from other pharmaceutical giants like GSK and Pfizer, who entered the market in the fall of last year. While Pfizer’s vaccine has lagged behind GSK’s, both companies have seen substantial sales figures.
Moderna’s full-year 2024 sales guidance includes revenue from their RSV vaccine, indicating confidence in the product’s potential. Furthermore, the approval of mRESVIA highlights the versatility of Moderna’s messenger RNA platform beyond the treatment of Covid. The company has a robust pipeline of over 40 products in development, with plans for combination shots targeting Covid and the flu, a stand-alone flu shot, a personalized cancer vaccine, and treatments for other infectious diseases.
Investors have shown a strong interest in Moderna’s mRNA product pipeline, with the company’s shares rising by over 60% this year after a decline in 2023. Moderna is aiming to return to sales growth in 2025 and break even by 2026, driven by the launch of new products and continued innovation. With ongoing trials for various vaccines and treatments, Moderna is poised for significant growth and impact in the healthcare sector.
Moderna’s FDA approval for their RSV vaccine for older adults represents a significant milestone for the company and demonstrates the potential of their mRNA platform in addressing diverse public health threats. With a focus on innovation, research, and expanding their product portfolio, Moderna is well-positioned to make a substantial impact on global healthcare in the coming years.
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