Toronto Star

Immunizati­on to begin next week, after Ottawa gives green light to Pfizer shot

First doses bound for Canada will travel through U.S., raising concern over Trump directive

- TONDA MACCHARLES

OTTAWA— The first shipment of a newly approved COVID-19 vaccine destined for Canada departs Friday on a journey now more perilous because of President Donald Trump’s executive order declaring vaccines should go to Americans first.

That’s because the first 30,000 doses from Pfizer/BioNTech will be flown by UPS from Puurs, Belgium, through Cologne, Germany, and on to Louisville, Kentucky, before being divvied up on planes travelling to Canada.

“If all goes well,” said Canada’s co-ordinator of the massive operation, Maj.Gen. Dany Fortin, the customized thermal shippers containing the precious cargo will arrive at 14 different sites across Canada on Monday. And an unpreceden­ted national vaccinatio­n campaign would begin with injections in

Canadian arms starting Tuesday.

However, Fortin acknowledg­ed there is a risk, although slight, to the Canadian vaccine shipment because of Trump’s order. “We’re looking at all the risks associated with transport,” he told the Star after a briefing.

A senior government official said the Trudeau government’s analysis is that the risk of disruption is low because Trump’s order does not mention the Defense Production Act — the law

Trump invoked to try to block earlier shipments to Canada of N95 masks made by 3M. But it’s not zero, the official acknowledg­ed.

Christina Antoniou, Pfizer Canada’s corporate relations director, said in a written reply to the Star that the vaccine “transits through the UPS hub in Louisville, Ky., in an internatio­nal transit zone. It then gets redeployed to Canadian airports.”

“We are still assessing the implicatio­ns of the executive order to determine its potential impact,” she wrote. “What we can reiterate at this time is that we are making vaccine doses available as quickly as possible based on the terms of current agreements with individual countries. We are committed to honouring our agreement with the Canadian government.”

Internatio­nal trade lawyer Lawrence Herman also thinks the risk is low, noting many analysts in the U.S. feel the president doesn’t have any legal basis for his order.

“That being said, you never know with Mr. Trump and his legal team. But I would think that Canada has every reason to believe that the legal arrangemen­ts we made with the supplier will be honoured.”

Anita Anand, the federal procuremen­t minister who landed the deal for 20 million doses of the Pfizer/BioNTech vaccine, and secured early delivery last weekend, said she was “confident” based on assurances from Pfizer that “the company with whom we have contracted will

ensure that those deliveries make it to our shores.”

It was a cautionary note on the day that Health Canada regulators granted a first formal authorizat­ion to Pfizer/BioNTech to distribute a novel mRNA vaccine, making Canada the third country to approve it, after the U.K, and Bahrain — news that brought an air of giddiness to Parliament Hill.

“This is a big deal and a good news day for Canadians,” said Prime Minister Justin Trudeau, “but we are not through this yet. We have a tough winter to get through and I know we are going to be able to get through it together.”

Federal Health Minister Patty Hajdu said she breathed “a sigh of relief.”

For weeks she had no communicat­ion with regulators, just signals that they were close to a decision this week.

The company is expected to ship up to four million of Cana

da’s pre-purchased 20 million doses by the end of March.

Anand said the Trudeau government is now looking at exercising its option to purchase up to an additional 56 million vaccine doses, especially if it can get assurances of early delivery dates for those options. “It makes sense,” she said.

Health Canada says all Canadians will get access to a vaccine by the end of September 2021, but Hajdu said only that her goal is to see the campaign reach all Canadians by the end of next year. Government sources, however, acknowledg­e the public uncertaint­y around a new vaccine could mean only around 70 per cent of Canadians will get vaccinated.

Dr. Supriya Sharma, the chief medical adviser to the regulatory team, said, “Canadians can have confidence in our rigorous review process and that the vaccine was authorized only after a thorough assessment of the evidence demonstrat­ed that it met Health Canada strict standards for safety, efficacy and quality.”

Sharma smiled when asked how Canada beat the U.S. to regulatory authorizat­ion, joking, “We’re just better.”

Turning serious, she said it wasn’t a race, but explained Canada got all the data it needed late Tuesday night, and issued an authorizat­ion that is broader than the emergency use authorizat­ion the U.S. Food and Drug Administra­tion is looking at. The U.S. could issue its decision Thursday.

“The geek in me is amazed,” said Sharma. “No one would have thought even when we looked back at the first discovery of the virus that less than a year later we’d be authorizin­g and then distributi­ng a vaccine.”

“At last we have a reason to feel optimistic … about to returning to the lives we led preCOVID,” said Dr. Howard Njoo, Canada’s deputy chief public health officer. “This has been a marathon, but now we are nearing the finish line.”

Health Canada says the vaccine is safe and effective for broad use in those aged 16 and over because the benefits clearly outweighed the risks. Sharma said regulators are still examining reports of two British health-care workers who had allergic reactions after receiving the vaccine this week.

Clinical trials of the vaccine had turned up just two allergic reactions out of nearly 44,000 people who were part of the trials — one received the vaccine, one received a placebo.

For now, only those with an allergy specifical­ly to listed ingredient­s of the vaccine should not receive an inoculatio­n, she said. The federal government has not yet advised people with a history of strong allergic reactions against getting vaccinated.

Sharma said Ottawa will make clear its recommenda­tion on that before immunizati­on begins next week.

Several terms and conditions including monitoring and reporting requiremen­ts have been placed on Pfizer/BioNTech, to track expected side effects such as headaches, fatigue and sore arms, along with rare adverse effects.

At Queen’s Park, Premier Doug Ford called it “phenomenal news.”

“As soon as vaccines arrive on Ontario soil, we will be ready to deliver and administer them,” Ford said in a written statement. “Friends, the light at the end of the tunnel grows brighter.”

The decision about who gets the vaccines first is up to provinces, which have the responsibi­lity for delivering health care.

Quebec has said it will start with long-term-care residents and workers. Manitoba said it will begin vaccinatin­g health workers on the front lines of the COVID-19 response.

Ontario has not revealed which hospitals will receive, thaw and mix the vaccines. It has said 21 hospitals are equipped with ultracold freezers to handle the vials from Pfizer, but is expecting about 40 per cent of the vaccines shipped to Canada.

 ?? ADRIAN WYLD THE CANADIAN PRESS ?? Health Canada’s chief medical adviser Supriya Sharma announced the approval of a COVID-19 vaccine on Wednesday: “Canadians can have confidence in our rigorous review process.”
ADRIAN WYLD THE CANADIAN PRESS Health Canada’s chief medical adviser Supriya Sharma announced the approval of a COVID-19 vaccine on Wednesday: “Canadians can have confidence in our rigorous review process.”

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