Moderna has announced the Company has shipped the 100-millionth dose of its COVID-19 vaccine to the U.S. Government. More than 67 million doses of the Moderna COVID-19 Vaccine have been administered in the U.S., according to the U.S. Centers for Disease Control and Prevention.
“I would like to thank the millions of people who have put their confidence in Moderna’s science and our COVID-19 vaccine. We are encouraged by the fact that more than 67 million doses have been administered in the U.S. and we are humbled to know that we are helping address this worldwide pandemic with our vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I would also like to thank the Moderna team, our suppliers and our U.S. manufacturing partners including Lonza and Catalent, for their tireless and extraordinary work in completing this important milestone.”
Moderna has increased its shipments to the U.S. government five-fold since receiving Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on December 18, 2020, from more than 16 million doses in the fourth quarter of 2020 to 88 million doses to date for the first quarter of 2021. Monthly shipments to the U.S. government in the first quarter were 18 million doses in January, 26 million doses in February, and 44 million doses to date in March. Looking forward, the Company expects to ship 40-50 million doses per month to the U.S. Government to fulfill its commitments. All U.S. government supply comes from Moderna’s dedicated supply chain in the U.S.
The Company expects to meet its commitment dates to the U.S. Government for all currently ordered doses of the Moderna COVID-19 Vaccine, including delivery of the second 100 million doses by the end of May 2021 and the third 100 million doses by the end of July 2021. The U.S. Centers for Disease Control and Prevention publicly displays U.S. COVID-19 vaccines delivered by vaccine type, including Moderna. These results generally track Moderna’s shipment records, but with a time lag.
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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 Diseases’ (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 Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing. On May 12, 2020, the U.S. FDA granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first participants in each age cohort were dosed in the Phase 2 study of the vaccine. On July 8, 2020, the Phase 2 study completed enrollment.
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, 2020 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, 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 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 (WHO).
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 Company’s COVID-19 vaccine development efforts with 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.
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.