Pfizer and BioNTech coronavirus vaccine accepted for rolling review in Canada

Health Canada will determine BNT162b2's suitability for approval as clinical trial data comes in.

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The coronavirus vaccine candidate being developed by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) is now undergoing its first regulatory review in North America. The two companies announced that their BNT162b2 has been accepted for a rolling review by Health Canada, that country's healthcare regulatory authority.

A rolling review is one undertaken while a candidate is still in development; this is done in cases of urgent need, as with the current global pandemic.

No estimate was provided as to when Health Canada might complete its review; the two companies wrote that the regulator "will not make a decision on whether to authorise any vaccine being considered under rolling review until it has received the necessary evidence to support its safety, efficacy and quality."

BNT162b2 is currently in phase 3 clinical trials, having reached that stage relatively quickly. As such, it is considered by many observers and pundits to be the leading COVID-19 vaccine candidate for approval.

According to Pfizer and BioNTech, around 37,000 participants have been enrolled in more than 120 testing sites around the world in the trials. Twenty-eight thousand of those patients have received the second dose of the two-dose vaccination.

Meanwhile, Pfizer and BioNTech continue to get their ducks in a row regarding the manufacture and distribution of BNT162b2 should it be approved for use. On Monday, the pair said they've signed an agreement to supply 1.5 million doses to New Zealand. The financial terms of the deal were not specified.

This article was originally published on Fool.com. All figures quoted in US dollars unless otherwise stated.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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