On Oct. 27, 2020, Moderna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) had started the rolling review process of mRNA-1273, the Company’s vaccine candidate against COVID-19.

This announcement followed positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase 1 study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.

The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. mRNA-1273 was being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S. On October 22, Moderna completed enrollment of the Phase 3 COVE study.