Health Canada submission follows international recommendations to develop monovalent XBB.1.5 COVID-19 vaccines

Moderna is prepared to deliver updated COVID-19 vaccines in time for the fall 2023 vaccination season

TORONTO, June 29, 2023 /CNW/ - Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has initiated the filing of a rolling New Drug Submission (NDS) to Health Canada for its updated monovalent COVID-19 vaccine, SPIKEVAX® XBB.1.5 (mRNA-1273.815) targeting the omicron subvariant XBB.1.5 of SARS-CoV-2. This follows Moderna's submission to the U.S. Food and Drug Administration for authorization.

"As the COVID-19 virus evolves, so must the vaccines. An updated vaccine will ensure Canadians have the most current and effective option to keep them protected. We have initiated our submission with Health Canada and, pending approval, will be ready to supply an XBB monovalent vaccine in time for the fall," said Patricia Gauthier, President and General Manager, Moderna Canada.

This is in alignment with 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.

The company is prepared to deliver updated COVID-19 vaccines in time for the fall vaccination season.

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.

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 initiation of a regulatory application to Health Canada for its updated monovalent COVID-19 vaccine; Moderna's ability to deliver its updated COVID-19 vaccine for the fall 2023 vaccination season, pending authorization; and the ability of Moderna's updated vaccine to generate an immune response against XXB variants of concern.  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 the date of this press release.

SOURCE Moderna, Inc.