Moderna Files for Emergency Use, Conditional Approval to FDA, EMA for COVID-19 Vaccine
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Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has filed requests for an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) for its COVID-19 vaccine candidate, mRNA-1273. The filings follow an interim data analysis that indicates a vaccine efficacy of 94.1%.

A meeting of a FDA advisory committee, the Vaccines and Related Biological Products Advisory Committee, will meet on December 17, 2020 to review the safety and efficacy data package for mRNA-1273. In addition, the European Medicines Agency reported this week (December 1, 2020) that it will review Moderna’s formal application for conditional marketing authorization and that if the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, its scientific committee for human medicines will conclude its assessment during an extraordinary meeting scheduled for January 12, 2020 at the latest. The company has also initiated the rolling review process with Health Canada, SwissMedic, the UK’s MHRA, the Ministry of Health in Israel, and the Health Sciences Authority in Singapore and intends to seek prequalification and/or emergency use listing with the World Health Organization.

By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 available in the US. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021. Moderna recently announced further progress toward ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.

The company expects that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will make a recommendation on immunization priorities. The company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the US will occur shortly after an emergency use authorization is granted. Moderna is working with the CDC, Operation Warp Speed, a US government initiative to speed development and delivery of COVID-19 vaccines and treatments, and McKesson, a pharmaceutical distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an emergency use authorization and similar global authorizations and approvals.

In addition, Moderna announced a supply agreement with the UK government for an additional 2 million doses of mRNA-1273 to the UK beginning in March 2021. The UK government has now secured 7 million doses of the vaccine.

Source: Moderna (filings), Moderna (UK supply pact), US Food and Drug Administration, and the European Medicines Agency

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