Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine

Clinical data show robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86
Updated vaccine to be available in pharmacies and care settings across the U.S. in the coming days

CAMBRIDGE, MA / ACCESSWIRE / September 11, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application(sBLA) for Spikevax® for ages 12 years and above. Emergency Use Authorization (EUA) for the Moderna COVID-19 Vaccine was also received for individuals 6 months through 11 years of age. Moderna's updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage 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 will begin shipping doses to vaccination sites across the U.S., with updated vaccines expected to be available in the coming days.

"COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season," said Stéphane Bancel, CEO of Moderna. "We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time."

In June 2023, the U.S. FDA advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition for the 2023 - 2024 vaccination season. At the June VRBPAC, Moderna presented clinical data showing that its updated vaccine resulted in robust immune responses across multiple XBB sublineages, including XBB.1.5 and XBB.1.16. In August, Moderna announced additional clinical trial data which showed the company's updated COVID-19 vaccine elicited an immune response in humans against EG.5 and FL.1.5.1, currently the dominant variants in the United States. Last week, the company shared additional clinical trial data confirming that the updated vaccine also elicited a human immune response against BA.2.86.

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, which is consistent with previous formulations of Spikevax.

Outside the U.S., regulatory applications for Moderna's updated COVID-19 vaccine are under review by other regulatory agencies with decisions anticipated in the coming weeks.

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 Moderna COVID-19 Vaccine (2023-2024 Formula) have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) for use in individuals 6 months through 11 years of age.

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.

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 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 vaccine.
• Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination.
• 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 vaccine.
• The vaccine may not protect all vaccine recipients.

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

• 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 SPIKEVAX Full Prescribing Information.

Please see the Moderna COVID-19 Vaccine (2023-2024 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 regarding: the ability of Moderna's updated COVID-19 vaccine to generate robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1 and BA.2.86, and to provide protection this season; Moderna's shipment of doses to vaccination sites across the U.S., and the availability of Moderna's updated vaccine in pharmacies and care settings across the U.S. in the coming days; the ability of updated vaccines to protect against SARS-CoV-2 as the virus continues to evolve; and anticipated decisions in the coming weeks with respect to regulatory applications for Moderna's updated COVID-19 vaccine outside the U.S. 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.