Introducing mNEXSPIKE: Moderna’s New COVID-19 Vaccine
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.
Stephen Hoge, our President, sat down to discuss the importance of today’s approval.
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.
Forward-Looking Statements
This post and accompanying video contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the timing for availability of mNEXSPIKE in the market; the size of the COVID vaccine market; upcoming milestones for Moderna’s pipeline programs, including Phase 3 readouts and potential product launches; and the potential for mNEXSPIKE to reduce the burden of disease from COVID-19. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this post are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this post
INDICATION
mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who have received a COVID-19 vaccine before and are:
65 years of age and older, or
12 years through 64 years of age at high risk for severe COVID-19.
Vaccination with mNEXSPIKE may not protect all people who receive the vaccine.
IMPORTANT SAFETY INFORMATION
You should not get mNEXSPIKE if you had a severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), or any Moderna COVID-19 vaccine or to any ingredient in these vaccines.
What are the risks of mNEXSPIKE?
There is a very small chance that mNEXSPIKE could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of mNEXSPIKE. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction can include:
Trouble breathing
Swelling of your face and throat
A fast heartbeat
A rash all over your body
Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported in clinical trials with mNEXSPIKE include:
Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness.
General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever
Tell your vaccination provider about all of your medical conditions, including if you:
have any allergies
had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received any other COVID-19 vaccine
have ever fainted in association with an injection
These may not be all the possible side effects of mNEXSPIKE. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at1-800-822-7967 or http://vaers.hhs.gov.
Please click for mNEXSPIKE Full Prescribing Information and Information for Recipients and Caregivers.