The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has begun the rolling review process of Moderna’s COVID-19 vaccine candidate, mRNA-1273.
This means that Moderna has started the rolling submission of mRNA-1273 for rolling review, in consideration of a potential authorisation by the MHRA.
The potential authorisation depends upon whether or not the vaccine candidate meets the MHRA’s rigorous standards of safety, effectiveness and quality standards, Moderna added in a statement.
“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,” he added.
The rolling review enables the MHRA to launch its independent assessment of the vaccine using the information submitted by Moderna, and also accept new evidence as and when it becomes available, until the application is deemed complete.
This process can help to reduce the time to authorisation of the vaccine candidate, while also maintaining high standards of safety, efficacy and quality.
In the phase I interim analysis of mRNA-1273, the shot was found to be generally well-tolerated across all age groups and induced immune responses against SARS-CoV-2, the virus which causes COVID-19.
The vaccine is currently being studied in a phase III trial of 30,000 participants at the 100µg dose level in the US. Earlier this week, Moderna completed enrolment of the phase III COVE study.