Moderna Inc EMA Recommends Authorization of Moderna Vaccine

TIDM0A45

Moderna Inc

19 October 2022

EMA Committee For Medicinal Products For Human Use Adopts Positive Opinion Recommending Authorization Of Moderna's Omicron BA.4-BA.5 Targeting Bivalent Covid-19 Vaccine In The European Union

Positive recommendation follows the recent approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, in September

CAMBRIDGE, MA / ACCESS WIRE / October 19, 2022 / Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization for mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID-19. Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of Spikevax bivalent Original/Omicron BA.4-5. This vaccine now joins Moderna's other updated booster vaccine, mRNA 1273.214, that targets the BA.1 variant, for use in individuals 12 years and older.

"The CHMP's positive recommendation for our BA.4/BA.5 bivalent booster, mRNA-1273.222, provides people across Europe with durable protection against the major Omicron subvariants in circulation as we head into the winter months when COVID-19 vaccination becomes crucial," said Stéphane Bancel, Chief Executive Officer of Moderna. "We look forward to the European Commission's authorization decision shortly."

Spikevax bivalent Original/Omicron BA.4-5 is a next-generation bivalent vaccine that contains 25 ug of mRNA-1273 (Spikevax) and 25 ug of a vaccine candidate targeting the Omicron variant of concern (BA.4/BA.5). Moderna's submission to the EMA is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, which recently received EMA approval. A Phase 2/3 clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.

Moderna has received authorizations for Omicron-targeting bivalent boosters in the United States, Australia, Canada, Europe, Japan, South Korea, Switzerland, Singapore, Taiwan, and the UK to date and has submitted regulatory applications worldwide.

About Moderna

In 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 in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators. 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 autoimmune 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: development of the Company's COVID-19 Vaccine (mRNA-1273.222, or Spikevax bivalent Original/Omicron BA.4-5); the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adoption of a positive opinion recommending conditional marketing authorization for Spikevax bivalent Original/Omicron BA.4-5 (mRNA-1273.222) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older; the potential authorization by the European Commission of mRNA-1273.222 as a booster dose for immunization to prevent COVID-19; and the anticipated timing for clinical data readouts from the Phase 2/3 trial of mRNA-1273.222. 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 most recent 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 hereof.

Moderna Contacts

Media:

Luke Mircea Willats

Director, Corporate Communications

[e-mail]

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

[e-mail]

SOURCE: Moderna, Inc.

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October 19, 2022 12:56 ET (16:56 GMT)