Moderna Files for FDA Authorization of Its Updated COVID-19 Vaccine

Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent lineage viruses

Pending authorization, Moderna's updated COVID-19 vaccine would be available in time for fall vaccination

Supply readiness follows months of manufacturing to ensure timely and ample supply

CAMBRIDGE, MA / ACCESSWIRE / June 22, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has completed submission of a regulatory application to the U.S. Food and Drug Administration for its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 (mRNA-1273.815).

"The agility of our mRNA platform has enabled us to update Spikevax, Moderna's COVID-19 vaccine, to target XBB variants with speed and clinical rigor," said Stéphane Bancel, CEO of Moderna. "We have been working diligently for months to build ample supply, with doses ready to ship in time for the fall vaccination season in the Northern Hemisphere. In addition, our preliminary clinical testing has demonstrated that mRNA-1273.815 is effective in generating an immune response against the current XBB variants of concern. Over the past three years, Spikevax has consistently reduced hospitalizations and severe disease outcomes from COVID-19, and we encourage individuals to speak to their healthcare providers about receiving an updated vaccine."

The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition. This is in alignment with other regulators and global public health agencies who have likewise recommended a monovalent XBB composition. At the recent VRBPAC, Moderna was the only company to submit preliminary clinical data comparing monovalent and bivalent vaccines and showing robust human immune responses across multiple XBB descendent sublineages such as XBB.1.5, XBB.1.16 and XBB.2.3.2.

The most common solicited local adverse event for Moderna's updated COVID-19 vaccine was injection site pain. The most common solicited systemic adverse events include headache, fatigue, myalgia and chills.

The company is initiating additional applications to regulators around the globe and is prepared to deliver updated COVID-19 vaccines in time for the fall vaccination season.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.

AUTHORIZED USE IN THE U.S.

Emergency uses of the vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19). Moderna COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 months through 5 years of age who were previously unvaccinated or vaccinated with one or two doses of Moderna COVID-19 Vaccine (no longer authorized). Moderna COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 years of age and older who were previously unvaccinated or vaccinated with one or more doses of an approved or authorized monovalent COVID-19 vaccine at least 2 months after receipt of any monovalent COVID-19 vaccine. Certain additional uses are authorized for immunocompromised patients and patients 65 years and older.

IMPORTANT SAFETY INFORMATION

• Do not administer the vaccines to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
• Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine.
• Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second primary series dose or first booster dose.
• Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
• Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccines.
• The vaccines may not protect all vaccine recipients.

Solicited adverse reactions included:

• 6 months through 36 months of age: Injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness
• 37 months of age and older: Injection site erythema, pain and swelling; arthralgia, axillary (or groin) swelling/tenderness, chills, fatigue, fever, headache, myalgia, nausea/vomiting, and rash

• The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.

Please see the Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 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 regarding: Moderna's regulatory application to the U.S. FDA for its updated COVID-19 vaccine; Moderna's ability to deliver its updated COVID-19 vaccine for the fall vaccination season, pending authorization; the ability of Moderna's updated vaccine to generate an immune response against XBB variants of concern; and Moderna's initiation of additional applications to regulators around the globe.. 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 those other risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the year ended December 31, 2022, 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 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.

Moderna Contacts

Media:
Elise Meyer
Sr. Director, Corporate Communications
617-852-7041
Elise.Meyer@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.