Moderna’s coronavirus vaccine candidate passes regulatory review in Canada


Modernof (NASDAQ: ARNM) The coronavirus vaccine candidate is now under regulatory inspection north of our border. The company announced Tuesday morning that it had launched a “continuous submission” of mRNA-1273 with Health Canada, the country’s health authority.

The adjective “rolling” means that a regulator is reviewing a submission while it is still in clinical trials. The regulator analyzes and analyzes the study or study data as it arrives, and makes its decision whether or not to approve a candidate when it considers that it has received sufficient information to do so.

Image source: Getty Images.

MRNA-1273 is currently in its Phase 3 trial. If it is finally approved by the Canadian authorities, Moderna should be able to supply it relatively quickly. The company said it “remains on track” to deliver up to 56 million doses to the country from next year. This will be supplied from Moderna’s stock in Europe; he hired two manufacturing companies, one Swiss and one Spanish, to manufacture the vaccine.

“We are pleased with the interactions with Canadian regulators and appreciate their guidance and confidence in Moderna to pursue an ongoing submission in Canada,” the company said, citing its CEO Stephane Bancel.

The news comes a day later Pfizer (NYSE: PFE) and his partner BioNTech (NASDAQ: BNTX) announced Monday that its high-level coronavirus vaccine candidate, BNT162b2, has also been accepted for continued review by Health Canada. Like Moderna’s candidate, BNT162b2 is undergoing advanced stage clinical testing.

Investors from all three companies have found the news from Moderna encouraging. Moderna’s stock closed up 3.9% on Tuesday, in contrast to the day’s slight drop in the S&P 500 index. BioNTech did even better, up 4.8%, while Pfizer advanced 0.2%.


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