PFE Pfizer Inc

By Paul Vieira and Vipal Monga 

Canada became the third country to authorize use of the Covid-19 vaccine produced by Pfizer Inc. and BioNTech SE, racing ahead of the U.S. Food and Drug Administration and Europe's main regulator to approve shots for its most vulnerable citizens.

Canada will now begin its immunization rollout as early as next week -- a daunting challenge for a sparsely populated country with the world's second-largest territory. The country is on schedule to begin inoculations next week, with a portfolio of vaccine candidates that it argues is among the most diverse among large economies.

The F.D.A. is expected to authorize use of the vaccine as early as this weekend, after its own study concluded the two-dose vaccine provided benefits even after just the first injection -- cutting the risk of getting Covid-19 by about half. The vaccine was found to be 95% effective after the second dose. The European Medicines Agency has said a decision on either the Pfizer-BioNTech shot or Moderna Inc.'s vaccine could come by the end of this month.

The U.K. and Bahrain approved the Pfizer-BioNTech vaccine within the past week. Canadian officials said Wednesday they expected to soon issue a decision regarding the Moderna vaccine.

"We are not in a race with any other regulator. What we are trying to do is beat this virus," said Supriya Sharma, senior medical adviser at Canada's health department. "We expedited the review, but we did not compromise in terms of the safety, efficacy and quality."

A spokeswoman for Pfizer's Canadian unit said Wednesday that Pfizer would supply Canada up to 76 million doses of the vaccine. The agreement calls for Canada to buy a minimum of 20 million doses with an option for 56 million more.

On Monday, Canada said it secured early delivery of 249,000 initial doses in anticipation that inoculations could start as early as next week.

As more countries move to authorize the first Covid-19 vaccine developed in the West, the companies behind it are working to meet production targets. Pfizer and BioNTech have presold around 600 million doses across the world but have produced just a fraction of that number so far.

Pfizer and BioNTech said that they would manufacture 50 million doses by the end of this year -- a goal they have already hit, according to people familiar with the matter -- and up to 1.3 billion by the end of 2021.

About half the existing doses have been produced in Europe, but more are expected to come from the U.S. as Pfizer integrates production lines in a Michigan factory that has been upgraded over the past few months.

While Europe and North America will receive most of the doses, according to people familiar with the companies' plans, BioNTech Chief Executive Ugur Sahin told The Wall Street Journal last month that doses would be delivered to whatever government authorizes the jab.

The U.S., which has ordered 100 million doses for $1.95 billion, is set to take delivery of around 25 million upon authorization, while the European Union, which purchased 200 million doses, will get over 20 million once it clears the vaccine. The U.K, which bought 30 million doses, is set to receive up to 5 million initially. Japan has ordered 120 million doses, and the Chinese territories of Hong Kong and Macao ordered 10 million.

The EU, which ordered the biggest single contingent of the vaccine, said it would hold a key meeting about whether to clear it for use on Dec. 29. Should the bloc fail to authorize the jab by then, a portion of its share would be shipped elsewhere as it would be unethical to store lifesaving vaccines over a longer period, according to a person familiar with the plan.

Canadian Prime Minister Justin Trudeau told The Wall Street Journal on Monday approval was imminent. He said the pending vaccine rollout -- combined with an aggressive fiscal policy -- would fuel an economic recovery that is expected to gather strength by the middle of 2021.

The goal, Mr. Trudeau said, is to inoculate three million Canadians by the end of the first quarter, and a majority of the country's 38 million residents by September.

Canada's vaccine strategy to date has focused on accumulating the most doses on a per capita basis as possible. Mr. Trudeau and other officials have boasted that Canada leads the world in that category. To date, Canada said it has secured access to over 400 million doses, but hasn't disclosed financial terms of deals reached with the seven leading candidates.

"Canada set out to build the best and most diverse portfolio of potential vaccines of just about any other country," Mr. Trudeau said during the Journal's CEO Council Summit this week. "With vaccines starting to be put into people's arms, hopefully next week...we really are seeing the beginning of the end" of the pandemic's hardship.

Amir Attaran, a professor in the school of epidemiology at the University of Ottawa, said Canada is overstating its success in getting access to the vaccines.

The six million doses -- enough to vaccinate three million residents -- that Canada will get by the end of March are only a fraction of the 50 million people the U.S. is expected to have inoculated. "That's not too good," said Mr. Attaran. Even after adjusting for population, that leaves Canada behind, he said.

Canada pursued an aggressive procurement program, partly because it lacked the manufacturing capacity to produce the type of vaccine contemplated for Covid-19, said Scott Halperin, director of the Canadian Center for Vaccinology. Its success in acquiring doses could give the country leeway to donate extra doses to lower-income countries, he said. "Canada has such an overabundance of supply," he said. "Vaccines will be gold."

The diversification will come in handy in dealing with certain regions. Canada has a contract with Moderna to acquire up to 56 million doses of its Covid-19 vaccine candidate. Mr. Trudeau said the country is counting on the Moderna vaccine, if approved, "to be able to reach further-off communities and northern Canadians," because its transport is less complicated than Pfizer's.

The Pfizer-BioNTech vaccine is difficult to store and transport. It must be kept refrigerated at temperatures between minus 112 and minus 76 degrees Fahrenheit to keep for six months. The vaccine will remain viable for roughly five days in normal refrigeration. Canadian officials say they have purchased 126 freezers to store the Covid-19 vaccines, including 26 for the ultralow temperature that the Pfizer-BioNTech shot requires.

"We are aware how complicated it is to distribute vaccines with very stringent requirements across the Canadian landscape in winter. There is a level of complexity here that's a master class in itself," said Maj.-Gen. Dany Fortin, who is overseeing vaccine logistics. Canada's federal government has responsibility for acquiring vaccines and allocating the doses to the provinces. The provinces, in turn, will run the immunization program, including where shots are injected.

Canadian public-health officials have said the elderly, residents and staff at nursing homes and front-line health-care workers should be among the first recipients of a Covid-19 vaccine. Roughly three-quarters of the country's nearly 13,000 Covid-19-related deaths originated in nursing homes, according to tracking by Ryerson University's National Institute on Aging.

Theresa Tam, Canada's chief medical officer, said there will be challenges because authorities can't move nursing-home residents easily to one of the initial 14 vaccination sites designed to inject the Pfizer-BioNTech shot. "I do think it's a fluid situation," she said. Maj.-Gen. Fortin said it may fall onto the Canadian provinces to find a solution.

Write to Paul Vieira at paul.vieira@wsj.com and Vipal Monga at vipal.monga@wsj.com

(END) Dow Jones Newswires

December 09, 2020 17:49 ET (22:49 GMT)

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