New U.S. government contract includes an award up to $1.74 billion for 66 million doses to be delivered in 2022; additional options, if exercised, may raise total to 300 million doses

CAMBRIDGE, MA / ACCESSWIRE / July 29, 2022 / Moderna, Inc., (Nasdaq:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. government has secured 66 million doses of a Moderna COVID-19 vaccine booster candidate, mRNA-1273.222, a bivalent booster candidate containing Spikevax™ plus the Omicron BA.4/5 strain mRNA.

The contract includes an award of up to $1.74 billion for the manufacture and delivery of 66 million doses of mRNA-1273.222, as well as options to purchase up to an additional 234 million doses of COVID-19 vaccine booster candidates from Moderna.

"We are pleased to extend our successful collaboration with the U.S. government," said Stéphane Bancel, Chief Executive Officer of Moderna. "Moderna's mRNA platform is enabling us to rapidly create mRNA-1273.222, a bivalent vaccine that specifically targets Omicron subvariants BA.4 and BA.5, the most prevalent variants of concern in the U.S. today. We remain fully committed to leveraging our innovative technology platform to offer tailored vaccines that help protect communities against COVID-19."

On July 11, 2022, Moderna announced that it is advancing two bivalent candidates for the fall based on different population health security strategies in different countries. mRNA-1273.222 contains the BA.4/5 Omicron strain and is being developed in accordance with recent FDA recommendations, while mRNA-1273.214 contains the BA.1 Omicron strain, which may be of benefit as noted by the WHO. These updated bivalent vaccines, if authorized, may offer higher, broader and more durable protection against COVID-19.

The contract announced today is supported by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and awarded by the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological Nuclear Defense (JPEO-CBRND) and the Army Contracting Command under contract number W58P05-22-C-0017.

INDICATION (U.S.)

SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

IMPORTANT SAFETY INFORMATION

Do not administer to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age.

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccine.

The vaccine may not protect all vaccine recipients.

Adverse reactions reported in clinical trials following administration of the vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site, and rash.

The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.

Please see the SPIKEVAX Full Prescribing Information. For information regarding authorized emergency uses of the Moderna COVID-19 Vaccine, please see the EUA Fact Sheet.

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 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: the Company's development of bivalent vaccine candidates against COVID-19 (mRNA-1273.214 and mRNA-1273.222); the U.S. government's purchase of doses of mRNA-1273.222 and potential for further option exercises for the purchase of this vaccine; and the potential for bivalent vaccines to offer higher, broader and more durable protection against COVID-19. 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 of this press release.

Moderna Contacts

Media:
Elise Meyer
Senior Director, Corporate Communications
617-852-7041
Elise.Meyer@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.