Moderna Submits Regulatory Application to the European Medicines Agency for Its Updated COVID-19 Vaccine

The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines

Pending approval, Moderna's updated COVID-19 vaccine will be available for fall vaccination with ample and timely supply

Preliminary clinical data show that the company's XBB1.5 monovalent vaccine induces an immune response against viruses of the XBB lineage

CAMBRIDGE, MA / ACCESSWIRE / July 3, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a regulatory application to the European Medicines Agency (EMA) for its updated COVID-19 vaccine encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2.

"We are proud to announce this filing for our updated COVID-19 vaccine and continue to support the European Union in protecting citizens against COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our preliminary clinical testing showed that our updated COVID-19 vaccine is effective in generating an immune response against the current XBB variants of concern, and we believe it will play a critical role in protecting against severe disease and hospitalization. We look forward to working with the EMA to bring our updated vaccine to people across the European Union."

The application is based on guidance from the European Centre for Disease Prevention and Control (ECDC) and the EMA, which recommended that COVID-19 vaccines be updated to a monovalent XBB.1.5 composition. This aligns with other regulators and global public health agencies recommending a monovalent XBB.1.5 composition. Additionally, Moderna has generated preliminary clinical data of its monovalent XBB.1.5 vaccine candidate showing an immune response against XBB descendent sublineages such as XBB.1.5, XBB.1.16, and XBB.2.3.2.

Moderna is in the process of submitting data to regulators worldwide to advance its updated COVID-19 vaccine in time for the autumn/winter vaccination season and has recently filed with the U.S. Food & Drug Administration, Health Canada, and other health authorities.

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.

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 potential authorization by European Union health officials of an updated COVID-19 vaccine (mRNA-1273.815); 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; Moderna's submission of data to regulators worldwide; and the potential for mRNA-1273.815 to protect against severe disease and hospitalization from COVID-19. 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 fiscal 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 this press release.

Moderna Contacts

Media:

Luke Mircea-Willats
Sr. Director, International Communications
Luke.mirceawillats@modernatx.com

Investors:

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

SOURCE: Moderna, Inc.