Therapeutic Goods Administration Provisionally Approves Moderna's Omicron-Containing Bivalent Booster Candidate, MRNA-1273.214, For Australia

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

mRNA-1273.214, an Omicron-containing bivalent vaccine, has demonstrated significantly higher antibody titers against all tested variants, including Omicron BA.1 and BA.4/5 subvariants

Moderna expects to supply mRNA-1273.214 to Australia in September

CAMBRIDGE, MA / ACCESSWIRE / August 30, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional approval for its Omicron-containing bivalent booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age 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 provisional approval from the TGA for our next-generation bivalent vaccine, mRNA-1273.214. Australia becomes one of the first countries in the world to approve an Omicron-containing vaccine, highlighting its continued stewardship in the fight against COVID-19," said Arpa Garay, Chief Commercial Officer at Moderna. "This is a vital step in helping to keep the Australian people safe from the ongoing threat that COVID-19 represents to global public health."

The decision from the TGA 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 a 50 µg booster dose of mRNA-1273 in previously uninfected participants. A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age. mRNA-1273.214's reactogenicity and safety profile is consistent with the currently authorized Spikevax (mRNA-1273) booster.

"I am incredibly proud to see our nation reach this critical step in providing access to this new vaccine. mRNA-1273.214 has demonstrated a superior neutralizing antibody response against Omicron (BA.1) and subvariants (BA.4/BA.5) as compared to mRNA-1273, in addition to having the potential for superior durability of protection," said Michael Azrak, General Manager of Moderna for Australia and New Zealand.

Moderna will continue to work with the Commonwealth of Australia on the implementation of this important vaccine for Australians with the aim of supplying product in September. Moderna has received approval for mRNA-1273.214 in the UK and Switzerland and has completed regulatory submissions for the next-generation vaccine worldwide.

Authorized use

Spikevax bivalent Original/Omicron is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

About Moderna

In 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 provisional approval of mRNA-1273.214 in Australia by the TGA, the Company's development of mRNA-1273.214; the ability of mRNA-1273.214 to induce higher neutralizing antibody titers against Omicron subvariants BA.4 and BA.5 than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); and the safety, efficacy, and tolerability of mRNA-1273.214 in adults ages 18 and above. 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.