Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2

Spikevax 2024-2025 formula expected to be available in pharmacies and care settings across the U.S. in the days immediately following approval

CAMBRIDGE, MA / ACCESSWIRE / AUGUST 22, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above. Emergency Use Authorization (EUA) for the Moderna's COVID-19 Vaccine (2024-2025 formula) was also granted for individuals 6 months through 11 years of age. Moderna's updated COVID-19 vaccine targets the KP.2 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. With the U.S. FDA's decision, Moderna's updated vaccine is expected to be available in the coming days.

"COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition. In the 2023-24 season, we saw more than 600,000 hospitalizations due to COVID in the U.S.[1] Staying up to date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness," said Stéphane Bancel, CEO of Moderna. "We appreciate the U.S. FDA's timely review and encourage individuals to speak to their healthcare providers about receiving their updated COVID-19 vaccine alongside their flu shot this fall."

The U.S. FDA's decision is based on a combination of manufacturing and preclinical data, as well as previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 mRNA vaccines. The updated vaccine composition is based on guidance from the U.S. FDA, which states that the preferred composition for the 2024-2025 updated COVID-19 vaccine is a monovalent KP.2 composition.

All of Moderna's COVID-19 vaccines have been well-tolerated. The most common solicited local adverse event for Moderna's COVID-19 vaccines is injection site pain. The most common solicited systemic adverse events include headache, fatigue, myalgia and chills.

In other countries, regulators have recommended a vaccine that specifically targets the JN.1 variant; Moderna is simultaneously manufacturing an updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. Additional regulatory applications for Moderna's updated COVID-19 vaccines targeting KP.2 or JN.1 are under review by other regulatory agencies, with decisions anticipated in the coming weeks.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.


Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

APPROVED INDICATION (U.S.)

SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

AUTHORIZED USE IN THE U.S.

The Moderna COVID-19 Vaccine has not yet been licensed by the U.S. FDA for use in individuals 6 months through 11 years of age, but has been authorized by the U.S. FDA under an Emergency Use Authorization (EUA).

IMPORTANT SAFETY INFORMATION

Contraindications

• Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Moderna COVID-19 vaccine.

Warnings and Precautions

• Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of SPIKEVAX.

• Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 years through 24 years of age.

• Syncope (fainting): May occur in association with administration of injectable vaccines, including SPIKEVAX. Procedures should be in place to avoid injury from fainting.

• Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to SPIKEVAX.

• Limitations of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients.

Adverse Reactions

The most commonly reported (≥10%) adverse reactions following any dose in any indicated patient population were pain at the injection site, fatigue, headache, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, and swelling at the injection site.

Reporting Adverse Events and Vaccine Administration Errors

To report suspected adverse reactions, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800-822-7967 or https://vaers.hhs.gov.

Please see the SPIKEVAX Full Prescribing Information.

Please see the Moderna COVID-19 Vaccine (2024-2025 Formula) Fact Sheet for Healthcare Providers Administering Vaccine for more information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's expectation that its updated vaccine will be available in pharmacies and care settings across the U.S. in the coming days; the efficacy and safety of Moderna's COVID-19 mRNA vaccines; and Moderna's regulatory applications for its updated COVID-19 vaccines outside the U.S., and its expectation for decisions from regulatory agencies in the coming weeks. The forward-looking statements in this press release 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, 2023, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, 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 press release 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 press release.

[1] https://www.preprints.org/manuscript/202405.1990/v1

Moderna Contacts

Media:
Elise Meyer
Senior Director, Corporate Communications
+1 617-852-7041
[email protected]

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

SOURCE: Moderna, Inc.