Moderna Announces New Supply Contract With The U.S. Government For An Initial 66 Million Doses Of A Moderna Bivalent Covid-19 Booster Vaccine With Options For U.S. Government To Purchase Up To An Additional 234 Million Doses

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

Moderna, Inc., 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 $1.74B 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.