Moderna (MRNA) says it's on track to deliver on its commitment of approximately 100 million doses to the United States government by the end of the first quarter

January 26, 2021 8:04 AM EST

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(Updated - January 26, 2021 8:05 AM EST)

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided a supply update for the Moderna COVID-19 Vaccine, reporting that 30.4 million doses have been supplied to the U.S. Government to date. The Company continues to work closely with the U.S. Government and to provide regular updates on supply and production. Approximately 10.1 million doses have been administered in the U.S., according to the U.S. Centers for Disease Control and Prevention1.

The Company confirms that it is on track to deliver on its commitment of approximately 100 million doses to the United States government by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. All U.S. supply comes from Moderna’s dedicated supply chain in the U.S. On January 4, the Company announced that it increased its base-case global production estimate from 500 to 600 million doses for 2021. Moderna is continuing to invest and add staff to build up to potentially 1 billion doses for 2021.

The Moderna COVID-19 Vaccine received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) on December 18, 2020 and Moderna began supplying to the government shortly thereafter. The U.S. Government has agreed to purchase 200 million doses of the Moderna COVID-19 Vaccine with options for potential purchase of 300 million additional doses.

About the Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine (also referred to as 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 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, 2020, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA 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 mRNA-1273. On July 8, the Phase 2 study completed enrollment.

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 July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. 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 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) with the European Medicines Agency. On November 30, the Company announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. 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 FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.

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 the Moderna COVID-19 Vaccine 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 the Moderna COVID-19 Vaccine under U.S. Department of Defense contract no. W911QY-20-C-0100.

Moderna has received authorization for its COVID-19 vaccine from regulatory authorities in the United States, Canada, Israel, the European Union, the United Kingdom and Switzerland. Additional authorizations are currently under review in other countries and by the World Health Organization. A summary of the Company’s work to date on COVID-19 can be found here.



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