Moderna Files for FDA EUA for mRNA-1273

Published on: December 1, 2020

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

Moderna announced on Nov. 30, 2020 that it had submitted a request for an Emergency Use Authorization (EUA) from FDA and an application for Conditional Marketing Authorization (CMA) with the European Medicines Agency (EMA). The primary efficacy analysis of the Phase III study of its COVID-19 vaccine candidate, mRNA-1273, confirmed the high efficacy observed at the first interim analysis and indicated a vaccine efficacy of 94.1%.

According to the press release, the primary analysis was 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 a point estimate of vaccine efficacy of 94.1%. In addition, 30 severe cases and one COVID-19-related death occurred in the placebo group and none in the mRNA-1273 vaccinated group. Efficacy was consistent across age, race and ethnicity, and gender demographics. Safety data continue to accrue; to date, no new serious safety concerns have been identified.

In addition to the FDA, EUA, and EMA CMA applications, Moderna has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO), the company said in the press release.

FDA’s Vaccines and Related Biological Products Advisory Committee meeting to review the safety and efficacy data package for mRNA-1273 is expected to be scheduled for December 17, 2020 and shipping of mRNA-1273 to designated distribution points throughout the US is expected to occur shortly after an EUA is granted.

Moderna is working with McKesson, a COVID-19 vaccine distributor contracted by the US government, and global stakeholders to be prepared for distribution. By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 available in the US and is on track to manufacture 500 million to one billion doses globally in 2021.

Source: Moderna