Swissmedic Authorizes Moderna's Omicron-Targeting Bivalent Booster Candidate, MRNA-1273.214

Switzerland becomes among the first countries in the world to approve the use of a next-generation bivalent COVID-19 booster vaccine

Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 subvariants when compared with mRNA-1273

Moderna is working with Swissmedic and the Government of Switzerland to make mRNA-1273.214 available in early September

CAMBRIDGE, MA / ACCESSWIRE / August 29, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic has granted temporary authorization for the use of Moderna's Omicron-targeting bivalent booster vaccine, Spikevax Bivalent Original/Omicron (mRNA-1273.214) for active immunization to prevent SARS-CoV-2 virus-induced Coronavirus-2019 disease for individuals aged 18 years and older. Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.1).

"We are delighted to receive authorization from Swissmedic for our next-generation bivalent vaccine, mRNA-1273.214. This is another example of Switzerland's continued leadership in helping to end the COVID-19 pandemic," said Arpa Garay, Chief Commercial Officer at Moderna. "Moderna is proud to play a key role in helping to protect the people of Switzerland from the ongoing threat that COVID-19 represents to global public health."

The decision from Swissmedic is based on clinical trial data from a Phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to the currently authorized 50 µg booster dose of Spikevax (mRNA-1273) in previously uninfected participants. A booster dose of Spikevax Bivalent Original/Omicron (mRNA-1273.214) increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, Spikevax Bivalent Original/Omicron (mRNA-1273.214) elicited higher neutralizing antibody titers against the Omicron subvariants BA.4 and BA.5 when compared to Spikevax (mRNA-1273) regardless of prior infection status or age, including in those aged 65 and older. mRNA-1273.214 was generally well tolerated, with a reactogenicity and safety profile consistent with the currently authorized booster.

Moderna is working with Swissmedic and the Government of Switzerland to make Spikevax Bivalent Original/Omicron available to people in Switzerland, with the aim of supplying product in early September. Moderna has received approval for mRNA-1273.214 in the UK and has completed regulatory submissions for the next-generation vaccine worldwide.

Authorized use

Spikevax bivalent Original/Omicron is indicated for active immunization to prevent SARS-CoV-2 virus-induced Coronavirus-2019 disease for individuals aged 18 years and older.

About Moderna

In over 10 years since its inception, Moderna has transformed from a science 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 in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows 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 ground-breaking 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 seven 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 development of the Company's COVID-19 Vaccine (mRNA-1273.214, or Spikevax Bivalent Original/Omicron); the authorization of mRNA-1273.214 in adults ages 18 years and older by Swissmedic; the ability of mRNA-1273.214 to induce higher neutralizing antibody titers against Omicron subvariants BA.1 and BA.4/5 than mRNA-1273); the safety, efficacy, and tolerability of mRNA-1273.214; the ability of mRNA-1273.214 to protect against COVID-19; the Company's aim to supply Spikevax Bivalent Original/Omicron in Switzerland in September; and regulatory submissions for mRNA-1273.214 that the Company has submitted worldwide. 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, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each 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:
Luke Mircea Willats
Director, Corporate 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.