Moderna announces dosing of first participant in Phase 2 study of company's Omicron-specific booster vaccine candidate for COVID-19

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CAMBRIDGE, Massachusetts , March 10, 2022 (press release) –

  • Moderna's Omicron-specific bivalent booster candidate (mRNA-1273.214) combines Moderna's Omicron-specific booster candidate (mRNA-1273.529) and the Moderna COVID-19 vaccine (mRNA-1273)
  • Moderna expects to enroll approximately 375 participants in the U.S.

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant has been dosed in the Phase 2 study of the Company's Omicron-specific bivalent booster candidate (mRNA-1273.214), which combines Moderna's Omicron-specific booster candidate (mRNA-1273.529) and the Moderna COVID-19 vaccine (mRNA-1273).

"We are pleased to begin this study of our bivalent booster candidate that includes our Omicron-specific candidate and the Moderna COVID-19 vaccine. Our mRNA platform allows us to pivot with speed and flexibility to create a bespoke vaccine to target new variants as they arise," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our goal has been to remain ahead of the virus and we are committed to generating and sharing data with public health authorities as they prepare for the fall booster season."

This extension of an earlier study will evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.214 as a single booster dose in adults aged 18 years and older who previously received the two-dose primary series of mRNA-1273 and a 50 µg booster dose of mRNA-1273 with the booster dose being at least three months ago. Moderna expects to enroll approximately 375 participants, which will be conducted at approximately 20 sites in the U.S.

Moderna is also evaluating its Omicron-specific booster candidate (mRNA-1273.529) in a Phase 2 study in the U.S. Separately, the Company is evaluating mRNA-1273.529 in a Phase 3 study the UK in collaboration with the National Institute for Health Research (NIHR). The Company expects to begin dosing with mRNA-1273.214 in that study soon.

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 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 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 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: expected enrollment in the Company's study of its Omicron-specific booster candidate (mRNA-1273.214); the Company's plans to generate and share data with public health authorities in advance of the fall booster season; and the Company's expectation regarding extension of its Phase 3 study of mRNA-1273.529 in the UK to include dosing with mRNA-1273.214. 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 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.

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