Moderna to file COVID-19 vaccine EUA request

By The Science Advisory Board staff writers

November 30, 2020 -- Moderna said it plans to request on November 30 an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional marketing authorization (CMA) from the European Medicines Agency (EMA) for its messenger RNA (mRNA)-1273 COVID-19 vaccine candidate.

Additionally, Moderna announced that the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for December 17.

The decision was prompted by a primary efficacy analysis conducted by a data safety monitoring board from the phase III Coronavirus Efficacy (COVE) study, based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in an estimated vaccine efficacy of 94.1%.

The analysis of a secondary endpoint, severe COVID-19 cases, found that all 30 severe cases occurred in the placebo group and none in the vaccinated group. This analysis builds on the interim efficacy data released by the company on November 16.

The study enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the U.S. National Institute of Allergy and Infectious Diseases and the U.S. Biomedical Advanced Research and Development Authority. A continuous review of safety data is ongoing and no new serious safety concerns have been identified.

The company plans to submit data from the phase III study to a peer-reviewed publication.

Moderna has already initiated a rolling review process with the EMA, Health Canada SwissMedic, the U.K. Medicines and Healthcare products Regulatory Agency, the Ministry of Health in Israel, and the Health Sciences Authority in Singapore. The company intends to seek prequalification and/or emergency use listing with the World Health Organization.

Moderna expects shipping of the vaccine to designated distribution points throughout the U.S. to occur shortly after an EUA is granted. Moderna is working with the U.S. Centers for Disease Control and Prevention, Operation Warp Speed, and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government, as well other global distributors.

By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 available in the U.S. and remains on track to manufacture 500 million to 1 billion doses globally in 2021.

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