Moderna Works With International Regulators to Speed Up COVID-19 Vaccine Review Process

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson.

To speed up the vaccine approval process in Canada, for instance, clinical trial data of Moderna’s vaccine candidate will now be reviewed by the country’s health regulators on a real-time basis. This rolling submission to Health Canada may allow a greater reduction in the time to authorization due to the provision that researchers can submit efficacy and safety findings in real time rather than waiting for the study to end.

Moderna is following in the footsteps of BioNTech and Pfizer, as well as AstraZeneca in becoming the third vaccine company to be accepted by Canada for this rolling submission process.

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. This evidence will be swiftly published after the authorization of the vaccine submission in an effort to promote transparency in the decision process.

“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,” Moderna’s CEO, Stéphane Bancel, said in a statement. “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.”

The Canadian Government announced on September 22 that it has increased its commitment to order up to 20 million doses of Moderna’s mRNA-1273 once approved. The Cambridge, Mass.-based vaccine company said it will be able to deliver up to 56 million doses of the vaccine to Canada starting in early 2021. Canada will receive the vaccine from Moderna’s European production centers, including from its Swiss strategic manufacturing partner Lonza and its Spanish fill-finish services partner ROVI.

Shares in Moderna rose 4% on the Tuesday following the announcement of the Health Canada agreement. Recent reports have shown that Moderna’s chief medical officer, Tal Zaks, has been selling his stocks every week through pre-scheduled trades, which has earned him over $50 million since the beginning of the COVID-19 pandemic.

In related news, Moderna announced on Wednesday it has 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 European Union Marketing Authorization under the EMA’s Fast-Track framework. The framework also offers a rolling review in addition to rapid scientific advice and accelerated assessment of outcomes data.

“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,” Bancel said. “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.”

In the U.S., the mRNA-1273 is being studied in a Phase III placebo-controlled trial comprising 30,000 participants. Trial participants are receiving the vaccine at the 100µg dose level. The COVE trial has already recruited up to 28,618 participants as of October 9. More than 22,194 of these volunteers have been treated with a second vaccination dose.

Moderna has said that its ongoing trial of its COVID-19 vaccine candidate in the United States is on track for a data readout by as early as November.