Biotech
Friday, May 31st, 2024 6:40 pm EDT
Key Points
- FDA Approval for Moderna’s RSV Vaccine: The FDA has approved Moderna’s vaccine for respiratory syncytial virus (RSV) for adults aged 60 and above, marking the company’s second product to enter the U.S. market, providing a much-needed revenue source amid declining demand for its Covid jab, its only commercially available product.
- Versatility of Moderna’s mRNA Platform: Moderna’s RSV vaccine, marketed as mRESVIA, is the first mRNA vaccine approved for a disease other than Covid, highlighting the versatility of Moderna’s mRNA platform. It addresses a significant public health threat, targeting a disease that kills thousands of seniors annually and results in numerous hospitalizations.
- Market Potential and Future Growth: Moderna’s approval demonstrates its potential beyond Covid treatment, showcasing its mRNA technology’s capabilities in addressing various diseases, including cancer and norovirus. With over 40 products in development, including combination shots for Covid and flu, Moderna anticipates returning to sales growth in 2025 and breaking even by 2026, driving investor optimism and indicating long-term growth prospects.
The Food and Drug Administration (FDA) granted approval for Moderna’s vaccine against respiratory syncytial virus (RSV) for adults aged 60 and above, marking the company’s second product entering the U.S. market. This approval arrives as Moderna seeks diversification amidst declining demand for its Covid vaccine, its sole commercially available product. Based on late-stage trials targeting older adults, the approval is significant as RSV poses substantial risks to seniors, causing thousands of deaths and hospitalizations annually. Moderna’s vaccine, branded as mRESVIA, stands out as the first mRNA vaccine authorized beyond Covid treatment and the sole RSV vaccine available in a pre-filled syringe, simplifying administration. An advisory CDC panel will assess recommendations for the vaccine’s use and target population in June, with Moderna anticipating favorable reception comparable to existing RSV shots from GSK and Pfizer. With Pfizer and GSK already marketing RSV vaccines since last fall, Moderna’s forecasted 2024 sales of approximately $4 billion include revenue from its RSV vaccine. This approval underscores Moderna’s mRNA platform’s versatility beyond Covid treatment, showcasing its potential against various diseases like cancer, norovirus, and RSV. CEO Stéphane Bancel emphasized the significance of this approval in broadening mRNA technology’s impact on global public health. Moderna’s extensive pipeline, with over 40 products under development, includes combination shots targeting Covid and flu, personalized cancer vaccines, and flu vaccines. Despite an initial delay in FDA approval due to administrative constraints, phase three trial data revealed Moderna’s RSV vaccine’s efficacy at 83.7%, declining to 63% after 8.6 months. While concerns arose about declining efficacy compared to Pfizer and GSK’s shots, Moderna emphasized the need for head-to-head trials due to differing study populations and methodologies. Safety concerns were minimal, with mild to moderate side effects like injection site pain, fatigue, and headache noted. Investors anticipate Moderna’s mRNA product pipeline’s long-term potential, evident in the company’s stock surge, signaling confidence in its future growth and innovation prospects.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/05/31/fda-approves-moderna-rsv-vaccine-for-seniors.html
