29 March 2021 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has shipped the 100-millionth dose of its COVID-19 vaccine to the US government, the company said.

More than 67m doses of the Moderna COVID-19 Vaccine have been administered in the US, according to the US Centers for Disease Control and Prevention1.

Moderna has increased its shipments to the US government five-fold since receiving Emergency Use Authorization from the US Food and Drug Administration on December 18, 2020, from more than 16m doses in the fourth quarter of 2020 to 88 m doses to date for 1Q21.

Monthly shipments to the US government in the first quarter were 18 m doses in January, 26 m doses in February, and 44 m doses to date in March.

Looking forward, the company expects to ship 40-50m doses per month to the US government to fulfill its commitments.

The company expects to meet its commitment dates to the US government for all currently ordered doses of the Moderna COVID-19 Vaccine, including delivery of the second 100m doses by the end of May 2021 and the third 100 m doses by the end of July 2021.

The US Centers for Disease Control and Prevention publicly displays US COVID-19 vaccines delivered by vaccine type, including Moderna. These results generally track Moderna's shipment records, but with a time lag.

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 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 US 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 US FDA and a Conditional Marketing Authorization application with the European Medicines Agency.

On December 18, 2020, the US 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 within the US Department of Health and Human Services 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 % of the allowable costs incurred by the company for conducting the program described in the BARDA contract.

The US government has agreed to purchase supply of mRNA-1273 under US Department of Defense contract no. W911QY-20-C-0100.

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization 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.