MHRA starts rolling review for Moderna’s COVID-19 vaccine candidate
The review with the UK’s MHRA is a separate process to that with the European Medicines Agency (Moderna has received confirmation from the EMA that its vaccine is eligible for submission). Earlier this month, Moderna also started a similar review process with Health Canada.
The rolling review with the UK's MHRA will be based on preclinical, CMC and clinical data for mRNA-1273 available to date. The process allows regulators to assess data as and when it becomes available.
“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,” said the company in a statement this morning.
“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.”
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center.
Moderna has previously announced positive results from a preclinical viral challenge study of mRNA-1273. A Phase 1 interim analysis, published in the New England Journal of Medicine, 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. This COVE trial completed enrolment last week. More than 25,650 participants have now received a second vaccination, according to figures from Moderna last Thursday.