U.S. government purchases additional 100 million doses of Moderna's COVID-19 vaccine

Moderna, Inc.Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the U.S. government has purchased an additional 100 million doses of Moderna's COVID-19 Vaccine, bringing its confirmed order commitment to 300 million doses.

Moderna has supplied 41 million released doses of the vaccine to the U.S. government to date. More than 22 million Americans have received the Moderna COVID-19 Vaccine in the U.S., according to the U.S. Centers for Disease Control and Prevention1. Moderna remains on track to deliver the first 100 million doses in the first quarter of 2021 and the second order of 100 million doses in May 2021. Moderna is working with its domestic manufacturing partners and the U.S. FDA to continue to explore ways to accelerate delivery, with the goal of providing this new order of 100 million doses before the end of July 2021. Moderna will continue to leverage the Company's U.S.-based manufacturing infrastructure to supply the Moderna COVID-19 Vaccine to the U.S. government.

"We appreciate the confidence that the U.S. government has demonstrated in our COVID-19 Vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "We continue to scale up our manufacturing capability, both in and outside of the United States. Our goal is to bring our vaccine to as many people as possible around the world to help end this pandemic. It is encouraging and humbling to know that more than 22 million Americans have already been protected with Moderna's vaccine."

Moderna's COVID-19 Vaccine Supply Agreements

Moderna has confirmed the following supply agreements of committed orders totaling more than 641.5 million doses:
  • United States: 300 million doses
  • European Union: 160 million doses
  • Japan: 50 million doses
  • Canada: 40 million doses
  • Republic of Korea: 40 million doses
  • Switzerland: 13.5 million doses
  • Colombia: 10 million doses
  • United Kingdom: 17 million doses
  • Israel: 6 million doses
  • Taiwan: 5 million doses
  • Singapore (undisclosed)
  • Qatar (undisclosed)
  • Other countries that have placed orders and have not been disclosed.

About the Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine. On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination). On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.

Authorized Use

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) 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. Moderna COVID-19 Vaccine is investigational and not approved by FDA.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six 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 and at unprecedented speed. 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 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years.

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