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Canada could approve Pfizer’s COVID-19 vaccine ‘around December’

Health Canada had said previously that an approval would likely come early in the first quarter, under a new accelerated review process very similar to that in place in the United States.

By: Reuters | November 27, 2020 9:41:49 am
Pfizer, Coronavirus vaccine, Canada Pfizer, Canada Covid vaccine, Health canada, world newsThe finding is one of several significant new results featured in the briefing materials, which span 53 pages of data analyses from the agency and from Pfizer.

Canada could approve Pfizer’s COVID-19 vaccine “around December,” about the same time as the United States and the European Union, a senior official at Canada’s drug regulator said on Thursday.

Health Canada had said previously that an approval would likely come early in the first quarter, under a new accelerated review process very similar to that in place in the United States. Pfizer and BioNTech’s vaccine is most advanced in Health Canada’s reviews, Supriya Sharma, senior medical adviser at Health Canada, said at a media briefing in Ottawa.

Asked whether any Canadians could receive a shot before the end of the year, Sharma said several things are happening at the same time – regulatory reviews, manufacturing, distribution -which makes it difficult to pinpoint dates.

“I think the general timelines of authorizations around December, and getting the shipments in January, and getting those moving in January are the best (forecasts) we can give at this time,” she said.

Canada is looking at the same data as regulators in the United States and European Union, and has a similar authorization system for use during a public health emergency, Sharma said.

“The way that the reviews are progressing is that we are expecting to make a final decision on the vaccine around the same time as both the U.S. FDA and the European Medicines Agency,” she said.

The European Medicines Agency is “very hopeful” it will be able to give a positive scientific opinion before Christmas, its executive director said on Wednesday.

The U.S. Food and Drug Administration (FDA) will hold a meeting on Dec. 10 at which members would discuss Pfizer’s vaccine. The agency declined last week to predict how long its review would take, but both Pfizer and U.S. Health Secretary Alex Azar have said the FDA could authorize the vaccine in mid-December.

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