Moderna, a biotechnology company, announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has started the rolling review process of mRNA-1273, the company’s vaccine candidate against COVID-19.
This announcement follows 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.
Moderna has initiated the rolling submission of mRNA-1273 data for rolling review, in consideration of a potential authorization by the MHRA, provided the vaccine candidate meets the MHRA’s rigorous standards of safety, effectiveness, and quality standards. This rolling review process allows the MHRA to begin its independent assessment using the information submitted by Moderna and accept new evidence as it becomes available until the application is deemed complete. This process can reduce time to authorization while maintaining usual high standards of safety, efficacy, and quality.
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 is currently being studied in a phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the US. On Thursday, October 22, Moderna completed enrollment of the phase 3 COVE study.