Therapy Areas: Infectious Diseases
Moderna Expects to Deliver 100m Doses of COVID-19 Vaccine to US Government by End of March
17 February 2021 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has provided a supply update for the Moderna COVID-19 Vaccine in the United States, reporting that 45.4m doses have been supplied to the US government to date.

The company said it continues to work closely with the US government to provide regular updates on supply and production.

An additional 33.2m doses of Moderna COVID-19 Vaccine have been filled in vials and are at various stages of final production and testing before release to the US government.

Approximately 25.5m doses of the Moderna COVID-19 Vaccine have been administered in the US, according to the US Centers for Disease Control and Prevention.

Short term delays in the final stages of production and release of filled vials at Moderna's fill and finish contractor Catalent have recently delayed the release of some doses, but these delays are expected to be resolved in the near term and are not expected to impact monthly delivery targets.

The company expects to meet commitment dates to the US government for all currently ordered doses of the Moderna COVID-19 Vaccine, including targeting delivery of the first 100m doses by the end of the first quarter 2021.

The company has moved forward delivery of its second 100m doses by one month, from end of June 2021 to end of May 2021.

It has moved forward delivery of its third 100 m doses by two months, from end of September 2021 to end of July 2021.

These commitments reflect a ramping up of production over the last few months and an expectation of further ramp up over the coming months.

Between October and the end of December, the company produced 17.8m doses that were released at the end of December 2020, and 19.1m doses were produced and released in January 2021, representing roughly a tripling of monthly production.

Looking forward, the monthly doses released to the US government are expected to double again by April, with an expected average of 30-35m doses per month for February and March, and 40-50m doses a month from April through the end of July.

The company does not intend to stockpile significant quantities to smooth shipments, choosing instead to ship doses to the US government as released.

Accordingly, weekly totals of released doses are expected to be volatile and may not reflect the underlying trajectory of manufacturing scale-up.

The company is in active and frequent communication with the US government to provide transparency on expected timing of deliveries in order to aid the US government's vaccine deployment efforts.

All US supply comes from Moderna's dedicated supply chain in the US Supply to locations outside of the US comes from dedicated supply points based outside of the US.

The Moderna COVID-19 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.

The US government has agreed to purchase a total of 300 m doses of the Moderna COVID-19 Vaccine.

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 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 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 U.S Food and Drug Administration 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 the vaccine. On July 8, the Phase 2 study completed enrolment.

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 application 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).

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 company said.
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