Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the U.S. government has exercised its option to purchase an additional 100 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 200 million doses.
Of the first 100 million doses purchased by the U.S. government, approximately 20 million doses will be delivered by the end of December 2020 and the balance will be delivered in the first quarter of 2021. Today’s new order of 100 million doses will be delivered in the second quarter of 2021. These deliveries are subject, in each case, to receipt of an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the vaccine.
Under the terms of the agreement, Moderna will continue to leverage the Company’s U.S.-based manufacturing infrastructure to supply mRNA-1273 to the U.S. government. As part of Operation Warp Speed, the U.S. government has the option to purchase up to an additional 300 million doses of mRNA-1273 from Moderna. The Company expects the U.S. government will provide the vaccine to Americans at no cost as previously announced.
“We appreciate the confidence that the U.S. government continues to have in mRNA-1273, our COVID-19 vaccine candidate, demonstrated by this increased supply agreement,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We continue to scale up our manufacturing capability in the U.S. and outside of the U.S. In parallel, we have filed for an Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization with the European Medicines Agency, and we will continue to work with regulatory agencies around the globe to continue the rolling review process. We remain committed to helping address this global pandemic with our vaccine.”
“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” said HHS Secretary Alex Azar. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”
Moderna’s COVID-19 Vaccine Supply Agreements
Moderna has confirmed the following supply agreements of committed orders totaling more than 390 million doses:
United States: 200 million doses with option for an additional 300 million doses
European Union: 80 million doses with option for an additional 80 million doses
Japan: 50 million doses
Canada: 40 million doses with option for an additional 16 million doses
Switzerland: 7.5 million doses
United Kingdom: 7 million doses
Israel: 6 million doses
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Other countries, which have placed orders and have not been disclosed.
Moderna is working with the U.S. CDC, Operation Warp Speed as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations and approvals.
A summary of the company’s work to date on COVID-19 can be found here.
About mRNA-1273
mRNA-1273 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 NIAID’s 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 NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 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 mRNA-1273. On July 8, the Phase 2 study completed enrollment.
Results from the second interim analysis of the NIH-led Phase 1 study of mRNA-1273 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 mRNA-1273 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 mRNA-1273 was published in The New England Journal of Medicine. On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of mRNA-1273 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) 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 mRNA-1273, its COVID-19 vaccine candidate, retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination). mRNA-1273 currently is not approved for use by any regulatory body.
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.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years.
