As Health Canada officials near a decision on whether to approve a COVID-19 vaccine, experts say the timing of the vaccine’s arrival will be crucial to cutting off the expected impact of the pandemic in the new year.
On Wednesday, British regulators gave their green light to the vaccine produced jointly by drug maker Pfizer Inc. and its German partner BioNTech, opening the door for vaccinations to begin in Britain as early as next week.
That milestone is increasing pressure on Ottawa and the provinces to ensure that vaccinations can begin promptly if an equivalent authorization is granted by Health Canada.
The Pfizer vaccine is one of three that federal regulators began considering in October as part of an expedited process. Together with vaccines developed by Moderna and AstraZeneca, its approval would signal a turning point in the battle against the COVID-19 pandemic in Canada.
In the near term, Ottawa has said it is expecting six million doses, enough for three million people, from Pfizer and Moderna in the first quarter of 2021.
In Britain, Health Secretary Matt Hancock said his country will begin receiving the first shipment of 800,000 doses within days and expects to receive millions of doses by the end of this year. In the U.S., some predictions estimate that 20 million Americans will be vaccinated before January.
In this country, some provinces are beginning to reveal what the rollout could look like, including Alberta, where Premier Jason Kenney said Ottawa has assured the province that it will receive its first shipment of vaccines on January 4, 2021. Further shipments will arrive in waves throughout the early part of next year, he said. Alberta wants 30 per cent of residents immunized in the first half of the year. Other provinces, including Ontario, have yet to detail their rollout strategies.
The stakes for federal regulators and those involved in the logistics of vaccine distribution across the country could hardly be higher. With case numbers and deaths projected to rise more steeply in Canada in the new year because of the pandemic, a few weeks’ difference in the arrival of the first vaccines could have a significant impact on the number of lives saved.
More than 12,300 have already died of the disease in Canada since the start of the pandemic. Recent modelling by the Institute for Health Metrics and Evaluation in Seattle shows that total deaths could cross the 30,000 mark by March 1, even with strict adherence to public-health guidelines such as mask wearing.
Jane Heffernan, a mathematician at York University in Toronto who specializes in the spread of infectious diseases, said that the impact of a vaccine arriving in Canada is highly time sensitive because of infection numbers approaching another peak some time in late February or early March, according to her own modelling.
Since the vaccines currently under review in Canada are administered in two doses that are spaced weeks apart, they would not be expected to reach their highest level of efficacy until about one month after the first dose.
Although the first vaccines to arrive may be administered only to the most vulnerable, ”for any subpopulation to receive maximal benefits, we need to vaccinate before the peak,” Dr. Heffernan said.
Yet, a hasty approval could also be disastrous if problems arise later on, since public confidence in the vaccines will be essential to beating back the pandemic in the long term.
“What we don’t want – by any country – is for a vaccine to be approved that isn’t safe. That will grind everything to a halt,” said Alan Bernstein, president and CEO of the Toronto-based research funding organization CIFAR.
The imminent availability of a vaccine in Britain has focused attention in Canada on the twin tracks of authorization and logistics, both of which will have to fall into place to avoid any delays in Canadians receiving approved vaccines as soon as they are produced.
Health Canada said it expects its independent review of the Pfizer vaccine to be completed soon, with the proviso that a vaccine will only be authorized if it meets with safety, efficacy and other requirements related to production and quality control.
The department also said that the timing of its decision on the vaccine will be “approximately aligned” with the U.S. and Europe, providing it has received all of the data it needs to complete the review process.
In the United States, an advisory committee to the U.S. Food and Drug Administration is set to weigh an emergency-use authorization of the Pfizer vaccine in an open meeting on Dec. 10. This step differs from Canada, where federal regulators have been poring through data provided by the company.
A vaccine review normally requires the equivalent of 2,000 person hours involving 7 to 10 reviewers, according to Supriya Sharma, a chief medical adviser at Health Canada. For the COVID-19 vaccines, the same effort is required, but the overall task has been compressed within a shorter number of days.
Dr. Sharma said that vaccine submissions are divided into three packages of information, covering animal studies, clinical trials and information on the manufacturing process. The analysis on all three fronts is then brought together to make a determination of whether the benefits of the vaccine outweigh any risks.
“If all of that is in compliance with the regulations then [the vaccine] gets an authorization,” Dr. Sharma said.
But a bigger and more politically volatile question is how quickly Canada can be ready to receive delivery of vaccines should that authorization be granted quickly.
In Ottawa, the British approval fuelled opposition party demands on Wednesday that the federal government clearly explain when Canada will receive vaccines and how they will be delivered to Canadians.
Conservative Leader Erin O’Toole asked how Canadians will feel when other economies open up before Canada as the country waits for enough vaccines.
Ottawa’s planning is especially critical for the Pfizer and Moderna vaccines, which have among the most complex distribution requirements because they need to be stored at ultracold and cold temperatures, respectively.
On Wednesday, a spokesperson for Public Services and Procurement Minister Anita Anand said Canada has so far secured nine ultracold freezers that can go to -80 C, needed for the Pfizer vaccine, and 33 regular freezers for the Moderna vaccine, which can go to -20 C.
Spokesperson Cecely Roy said in total Canada has placed orders for 26 ultracold freezers and 100 standard freezers. On average, each freezer can hold 280,000 doses, but the regular freezers can only hold between 96,000 and 160,000 doses. The minister’s office did not disclose whether the freezers that have already arrived in Canada have been distributed across the country.
Pfizer told The Globe and Mail that it is working directly with several provincial and territorial governments to support distribution of its vaccine, which will be shipped in frozen vials from its manufacturing facilities to point-of-use locations in Canada in a “just-in-time” delivery fashion. The vaccine can be kept cold in special containers using dry ice until they reach their destination.
In Alberta, Mr. Kenney said he expects 435,000 people will receive vaccine shots in the first quarter of 2021, or roughly 10 per cent of the province’s population. The first phase will focus on Alberta’s most at-risk groups, including residents of long-term care homes, designated supportive-living facilities, and staff who work in those operations. It will also include Indigenous people living on reserves and health-care workers most needed to keep facilities operating and most likely to transmit the virus to others at risk.
“While we cannot control when these vaccines arrive in Alberta, we can make sure that when we get them, we are ready to roll them out as quickly as we can.”
With reports from Kelly Grant, Carrie Tait and The Associated Press
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