Moderna (MRNA) introduces mNEXSPIKE, New COVID-19 Vaccine

Moderna (NASDAQ: MRNA) CEO Stéphane Bancel on the company's blog on Tuesday:

I am proud to share that mNEXSPIKE®, our new COVID-19 vaccine, is now approved in the U.S., marking Moderna’s third approved product and fifth vaccine program to achieve positive Phase 3 results.

This timely approval will allow for the use of mNEXSPIKE in all adults 65 and older, as well as individuals aged 12-64 with one or more underlying conditions that puts them at high risk for severe outcomes from COVID-19. We are proud of our platform’s continued positive impact on human health, and our relentless commitment to excellence.

We Obsess Over Innovation

As pioneers in mRNA technology, the Moderna team feels a strong responsibility to obsess over innovation, tirelessly working to improve the science behind our products to reduce disease burden and ultimately advance public health. Since the beginning, we’ve rejected the idea of complacency as there’s always another advancement to pursue.

mNEXSPIKE is a prime example of that pursuit. Our vaccine innovation in COVID-19 didn’t stop after the invention of our mRNA-1273 vaccine early in January 2020. Instead, we continued to iterate on its design. With the benefit of years of real-world data and a deeper understanding of the virus, we explored if alternative vaccine design strategies could be more effective. mNEXSPIKE was born from this continued push for excellence. Its streamlined vaccine design aims to target key parts of the spike protein rather than the entire spike protein, and at a lower dose.

The Ongoing Burden of COVID-19

COVID-19 remains a significant public health threat. Over 47,000 Americans died from COVID-19 in 2024 – about one death every 11 minutes. Older adults face disproportionately higher risks of severe illness, hospitalization and death – adults aged 65 and older account for two-thirds of COVID-19 related hospitalizations and 80% of all adults hospitalized with COVID-19 who died in hospitals were 65 years or older. Many older adults have multiple comorbidities including obesity (1.4x risk), diabetes (1.8x risk), and chronic lung disease (3.2x risk) that can further amplify vulnerability.

mNEXSPIKE has the potential to be a critical tool as we aim to reduce the burden of disease.

Delivering on the Promise of mRNA

The flexibility and adaptability of our mRNA platform allows for constant innovation – complacency is not an option. We are looking forward to many more upcoming moments when we will continue to show the promise of mRNA–with several Phase 3 readouts approaching and continued momentum in our priority programs across respiratory, latent, oncology and rare disease. Our commitment to patients and advancing mRNA medicine has never been stronger.

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