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Moderna's Coronavirus Vaccine Candidate Advances to Regulatory Review in Canada

By Eric Volkman – Oct 13, 2020 at 4:31PM

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It's the second "rolling review" of a top coronavirus vaccine candidate in as many days.

Moderna's (MRNA 3.15%) coronavirus vaccine candidate is now under regulatory inspection north of our border. The company announced Tuesday morning that it has initiated a "rolling submission" of mRNA-1273 with Health Canada, the country's healthcare authority.

The "rolling" adjective means that a regulatory body is reviewing a submittal while it is still undergoing clinical testing. The regulator parses and analyzes data from the study or studies as it comes in, and makes its decision whether or not to approve a candidate when it feels it has received sufficient information to do so.

A syringe being filled with a vaccine from a vial.

Image source: Getty Images.

mRNA-1273 is currently in its phase 3 trial. If it is ultimately approved by the Canadian authority, Moderna should be able to supply it relatively quickly. The company said it "remains on track" to provide up to 56 million doses to the country beginning next year. This will be supplied from Moderna's stockpile in Europe; it has contracted two manufacturing companies, one Swiss and one Spanish, to make the vaccine.

"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," the company quoted its CEO Stephane Bancel as saying.

The news comes one day after Pfizer (PFE 1.07%) and its partner BioNTech (BNTX 0.62%) announced Monday that their high-profile coronavirus vaccine candidate, BNT162b2, had similarly been accepted for a rolling review by Health Canada. Like Moderna's candidate, BNT162b2 is undergoing late-stage clinical testing.

Investors of all three companies found Moderna's news heartening. Moderna's stock closed 3.9% higher on Tuesday in contrast to the slight decline of the S&P 500 index on the day. BioNTech did even better, rising 4.8%, while Pfizer inched up by 0.2%.

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Stocks Mentioned

Moderna Stock Quote
Moderna
MRNA
$179.00 (3.15%) $5.46
Pfizer Stock Quote
Pfizer
PFE
$50.24 (1.07%) $0.53
BioNTech Se Stock Quote
BioNTech Se
BNTX
$162.63 (0.62%) $1.01

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

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