Moderna COVID-19 vaccine under rolling review process in Canada, EU

19-Oct-2020 - Last updated on 22-Oct-2020 at 19:38 GMT

Moderna is engaging with international regulators to accelerate approval of its COVID-19 vaccine candidate.

To speed up the vaccine approval process in Canada, clinical trial data of Moderna’s vaccine candidate, mRNA-1273, will now be evaluated by the country’s health regulators on a real-time basis.

Last week saw Moderna’s rolling submission accepted under the Canadian Minister of Health's Interim Order, which permits companies to present safety and efficacy data and information as they become available, without waiting for studies to end.

Such an approach to reviews could speed up the process of approving a successful COVID-19 vaccine.

Moderna said initiation into this fast-tracked review process follows positive results from a preclinical viral challenge study of its vaccine candidate and the positive interim analysis of the Phase 1 study of mRNA-1273 in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+), which was published in the New England Journal of Medicine.

It is the third COVID-19 vaccine candidate accepted by Canada for this rolling submission process, with those being developed by BioNTech and Pfizer and AstraZeneca already privy to the same assessment method.

Canada’s government has said that it will not authorize any vaccine under the rolling review program until all necessary safety and efficacy evidence has been reviewed. The evidence will be published following the authorization of the vaccine to ensure transparency in the process.

The Canadian government has pledged to order up to 20 million doses of Moderna’s mRNA-1273, once it is approved; that vaccine supply will be sourced from Moderna’s European production capacity with its strategic manufacturing partner Lonza of Switzerland, and ROVI of Spain for fill-finish services.

“We are pleased with the interactions with the Canadian regulatory authorities and we appreciate their guidance and confidence in Moderna to pursue a rolling submission in Canada for our COVID-19 vaccine candidate, mRNA-1273,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We are committed to developing a safe and effective vaccine following the guidance of regulatory agencies around the world and we will continue working closely with Health Canada.”

mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100µg dose level in the US. As of Friday, October 9, the Phase 3 COVE study has enrolled approximately 28,618 participants with 22,194 having received their second vaccination.

EU fast-track framework

Last week also saw Moderna announce it had received confirmation from the European Medicines Agency (EMA) that its COVID-19 vaccine candidate can now be submitted early for approval. The vaccine is eligible for submission of an application for a EU Marketing Authorization under the EMA’s Fast-Track framework. The EU framework also ensures a rolling review process.

“We are committed to developing a safe and effective vaccine following the guidance of regulatory agencies and we will continue our ongoing dialogue with the EMA,” commented Bancel. “Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.”

Earlier this month, Moderna said it would not enforce patents related to its experimental COVID-19 vaccine during the pandemic and that it is willing to license its IP for COVID-19 vaccines by request for the post-pandemic period, adding that it feels obliged to use its resources to bring the pandemic to an end as quickly as possible.