MHRA begins rolling review of Moderna's Covid-19 vaccine

The Medicines and Healthcare Products Regulatory Agency (MHRA) has started a rolling review of the mRNA-1273 Covid-19 vaccine currently in development by biotechnology company Moderna.

The announcement follows positive results from a preclinical viral challenge study of mRNA-1273, results of which were published in the New England Journal of Medicine.

Moderna’s Phase 1 interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 in 40 adult participants across two dose levels (25 and 100 µg). Results show that both dose levels were generally well-tolerated and induced rapid and strong immune responses against SARS-CoV-2. Moderna’s vaccine is now being studied in a Phase 3 randomised placebo-controlled trial of 30,000 participants in the US.

Now, Moderna has initiated the rolling submission of mRNA-1273 data for rolling review, in consideration of potential authorisation by the MHRA. This is provided the vaccine candidate meets the MHRA’s standards of safety, efficacy and quality. A rolling review takes into account data from clinical trials and studies as they become available. It is designed to speed up the assessment process for what are considered promising medicines during a public health emergency.

Moderna states this process will allow 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.

“We appreciate the collaboration we have had to date with regulatory authorities around the world, and the process established by the MHRA to address this ongoing public health emergency,” said Stéphane Bancel, chief executive officer of Moderna. “This is a great example of what’s being done to support efforts to deliver a safe and effective vaccine to UK citizens as safely and efficiently as possible.”