EMA begins rolling review of Moderna’s COVID-19 vaccine candidate
The vaccine candidate, mRNA-1273, reported 94.5% efficacy in its Phase 3 interim analysis yesterday. This Phase 3 study is being carried out with 30,000 participants in the US.
A rolling review allows vaccine developers to submit information from earlier trials to regulators as and when it becomes available. In Europe, the EMA’s human medicines committee (CHMP) will carry out a rolling review of the vaccine via Moderna’s subsidiary, Moderna Biotech Spain. The EMA is already in the processing of carrying out rolling reviews for AstraZeneca and Pfizer’s vaccine candidates, both of which started last month.
“The CHMP’s decision to start the rolling review of [Moderna’s] mRNA-1273 is based on preliminary results from non-clinical studies and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus,” says a statement from the EMA.
“The Committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data).
“All the available data on the safety of the vaccine as well as its pharmaceutical quality (such as its ingredients, the way it is produced, stability and storage conditions) will also be reviewed as they become available.”
Information from large scale clinical trials will follow into the application when available to inform how effective the vaccine is.
Meanwhile, the EU has completed successful exploratory talks with Moderna for the supply of the vaccine; saying yesterday that the completion of a deal is expected soon.
Global regulatory review process for mRNA-1273
Moderna has already started similar rolling review processes with Switzerland’s Swissmedic this month, and with the UK’s MHRA and Health Canada last month.
A request for Emergency Use Authorization (EUA) in the US is expected ‘in the coming weeks’ as Moderna compiles the necessary two months of data required by the FDA.
Meanwhile, Moderna continues to scale up global manufacturing capability as it looks to produce around 20 million doses of the vaccine in the US by the end of 2020 and up to 1 billion doses globally next year.
“The start of the rolling review process marks an important next step as we continue to advance mRNA-1273 in collaboration with European regulatory authorities,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We will continue our ongoing dialogue with the EMA as we seek to develop a safe and effective vaccine.
"We are also scaling up global manufacturing with our strategic partners Lonza of Switzerland, and ROVI of Spain to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.”