Moderna provides COVID-19 vaccine supply update

Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, provided a supply update for the Moderna COVID-19 Vaccine, increasing its base-case global production estimate from 500 to 600 million doses for 2021. Moderna said it is continuing to invest and add staff to build up to potentially 1 billion doses for 2021.

The Company said it expects about 100 million doses to be available in the United States by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. Moderna reported that approximately 18 million doses have been supplied to the U.S. Government to date. The 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. Additional vaccine doses have also been supplied to the Canadian government following authorization by Health Canada's Interim Order on December 23, 2020.

"Our effectiveness in providing early supply to the U.S. and Canadian governments and our ability to increase baseline production estimates for 2021 are both signals that our scale up of mRNA vaccine production is a success," said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. "I want to thank the many private and government collaborators, contractors and the hundreds of Moderna staff who have been working thoughtfully and tirelessly to accomplish this."

Moderna is partnered with Lonza Ltd. for production inside and outside the United States. Fill-finish services are provided by Catalent Inc. in the U.S., and by ROVI and Recipharm outside the U.S. 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. The Canadian Government has agreed to purchase 40 million doses.

About 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 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, 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 U.S. FDA and a Conditional Marketing Authorization (CMA) 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.

Authorized Use

The Moderna COVID-19 Vaccine has been authorized for emergency use in the U.S. 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 (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

About Moderna

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years.

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