Moderna receives FDA approval for COVVI-19 MNEXPIKE VACCIN

MNEXPIKE becomes the third product approved by the Moderna FDA

Cambridge, my / Access news / May 31, 2025 / Moderna, Inc. (Nasdaq: Arnm) announced today that the Food and Drug Administration of the United States (FDA) approved MNEXSPIKE® (MRNA-1283), a new COVVI-19 vaccine, for use in all adults aged 65 and over, as well as individuals aged 12 to 64 with at least one or more underlying risk factors as defined by Centers for Disease Control and Prevention (CDC).⁽¹⁾

“The approval of the FDA of our third product, MNEXSPIKE, adds a new important tool to help protect people at high risk of serious disease of COVVI-19,” said Stéphane Bancel, Managing Director of Moderna. “Covid-19 remains a serious threat of public health, with more than 47,000 Americans who die from the virus last year. We appreciate the FDA rapid examination and thank the entire Moderna team for their hard work and their continuous commitment to public health.”

MNEXPIKE FDA approval is based on the results of a randomized clinical trial, blind to the observer and active controlled (Clinicaltrials.gov Identifier: NCT05815498), who scored about 11,400 participants aged 12 and over. The objective of primary efficiency in this study was to demonstrate the effectiveness of the non-lower vaccine against COVVI-19 from 14 days after MNEXPIKE compared to that after the comparator vaccine, the mRNM-1273 (Spikevax®), the Original COVVI-19 vaccine of Moderna. Participants received a dose of 10 μg of RNA-1283, or a dose of 50 μg of mRNA-1273. MRNA-1283 showed a relative relative efficiency of 9.3% higher (RVE) compared to mRNA-1273 in individuals aged 12 and over, and in a descriptive subgroup analysis, an RVE of 13.5% in adults aged 65 and over.

In phase 3 trial, mRNA-1283 proved to have a safety profile similar to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most often asked side effects were pain, fatigue, headache and myalgia of the injection site.

Moderna provides that MNEXPIKE will be available for populations eligible for the United States for the 2025-2026 respiratory virus season, alongside Spikevax and Mresvia®The approved respiratory syncytial virus vaccine (RSV).

ARNA-1283 is being examined with regulators in several markets around the world.

About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Thanks to the advancement of mRNA technology, Moderna reinvents the way drugs are manufactured and transform the way we treat and prevented diseases for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed drugs at an unprecedented speed and efficiency, including one of the oldest and most effective vaccines COVID-19.

Moderna’s mRNA platform has enabled the development of therapies and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team motivated by modern values ​​and mentalities to change the future of human health in a responsible way, Moderna strives to offer people as much impact as possible through mRNA medicines. For more information on Moderna, please visit Modernatx.com And connect with us to X (formerly Twitter), Facebook, Instagram, YouTube and Linkedin.

MNEXPIKE®, Mresvia® and Spikevax®Are TEMPEATED Marks of Modern.

INDICATION
MNEXSPIKE is a vaccine to protect against COVID-19. MNEXSPIKE is intended for people who have already received a COVVI-19 vaccine and are:

• 65 years and over, or

• 12 years to 64 years old at high risk of severe covid-19.

Vaccination with MNEXPIKE may not protect all people who receive the vaccine.

Important security information

You shouldn’t get mnexpike if You have had a severe allergic reaction after a previous dose of MNEXPIKE, Spikevax (COVVI-19 vaccine, mRNA) or any modern covid-19 vaccine or any ingredient in these vaccines.

What are the risks of MNEXSPIKE?
There is a very small chance that MNEXSPIKE can cause a severe allergic reaction. A severe allergic reaction would generally occur in a few minutes to 1 hour after obtaining a dose of MNEXSPIKE. For this reason, your health professional may ask you to stay for a short time where you received your vaccine. Signs of a severe allergic reaction may include:

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the mucosa outside the heart) have occurred in some people who received COVVI-19 mRNM vaccines. Myocarditis and pericarditis according to COVVI-19 mRNM vaccines occurred most often in men aged 12 to 24. You should consult a doctor immediately if you or your child have one of the following symptoms after receiving the vaccine, especially for 2 weeks after receiving a dose of vaccine:

The side effects that have been reported in clinical trials with MNEXPIKE include:

• Injection site reactions: pain, sensitivity 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

Talk to your vaccination provider of all your medical conditions, including if you:

• have allergies

• Had a serious allergic reaction after receiving a previous dose of any COVVI-19 vaccine

• had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the mucosa outside the heart)

• have a fever

• have a bleeding disorder or are on a blood thinness

• are immunocompromised or on a drug affecting your immune system

• are pregnant or plan to become pregnant

• breastfeeding

• received any other COVVI-19 vaccine

• have already passed out in association with an injection

These are not all possible side effects of MNEXPike. Ask your healthcare provider on the side effects that concern you. You can point out the side effects to System of reports on unwanted vaccine events (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.

Please click For MNEXPIKE, full prescription information.

Prospective declarations
This press release contains prospective declarations within the meaning of the 1995 law on the reform of the dispute of private securities, as amended, including the declarations concerning: the efficiency, safety and the tolerability of MNEXspike; and the availability of Moderna’s respiratory vaccines for the 2025-2026 season. The prospective declarations of this press release are neither promises nor guarantees, and you should not grant undue dependence to these prospective declarations because they imply risks, uncertainties and other known and unknown factors, many of which are outside the will of Moderna and which could ensure that real results differ materially from those expressed or implicit by these prospective states. These risks, uncertainties and other factors include, among other things, these risks and uncertainties described in the framework of the “risk factors” of the section in the Moderna annual report on form 10-K for the exercise completed on December 31, 2024, and in the subsequent deposits made by Moderna with the Securities and Exchange American Commission, which are available on the website on the website Dry on the dry website on the SEC website on the EC website www.sec.gov. Unless the law required, Moderna declines any intention or responsibility to update or revise the prospective declarations contained in this press release in the event of new information, future developments or otherwise. These prospective declarations are based on Moderna’s current expectations and only speak on the date of this press release.

Modern contacts
Media:
Chris Ridley
Head of World Media Relations
+1 617-800-3651
Chris.ridley@modernatx.com

Investors:
Lavine Talukdar
Senior vice-president and head of investors relations
+1 617-209-5834
Lavina.talukdar@modernatx.com

Display the original press release On Access Newswire