5 January 2021 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has provided a supply update for the Moderna COVID-19 Vaccine, increasing its base-case global production estimate from 500 to 600m doses for 2021, the company said.

Moderna said it is continuing to invest and add staff to build up to potentially 1bn doses for 2021.

The company said it expects about 100 m doses to be available in the United States by the end of the first quarter of 2021, with 200 m doses total available by the end of the second quarter.

Moderna reported that approximately 18m doses have been supplied to the US government to date.

The vaccine received Emergency Use Authorization from the US Food and Drug Administration on December 18, 2020 and Moderna began supplying to the government shortly thereafter.

Additional vaccine doses have also been supplied to the Canadian government following authorization by Health Canada's Interim Order on December 23, 2020.

Moderna is partnered with Lonza Ltd. for production inside and outside the United States. Fill-finish services are provided by Catalent Inc. in the US, and by ROVI and Recipharm outside the US.

The US government has agreed to purchase 200 m doses of the Moderna COVID-19 Vaccine with options for potential purchase of 300 m additional doses. The Canadian government has agreed to purchase 40 m doses.

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 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, 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 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.

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 US FDA and a Conditional Marketing Authorization 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) and on December 30, interim safety and primary efficacy results from the Phase 3 trial were published in The New England Journal of Medicine.

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 Moderna COVID-19 Vaccine has been authorized for emergency use in the US by the FDA 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 and has been authorized by Health Canada for the immunization of Canadians 18 years of age and older under an Interim Order.

Moderna has submitted the final Conditional Marketing Authorization Application following rolling submissions with the European Medicines Agency and several other regulatory agencies around the world.