Following news that the United Kingdom has authorized a COVID-19 vaccine for use, questions are emerging about what the new approval could mean for other countries looking to secure a vaccine candidate in the race against the novel coronavirus.
Britain gave the green light to the COVID-19 vaccine candidate from American drugmaker Pfizer and Germany’s BioNTech on Wednesday and expects to start its first vaccinations in the country within days.
Chief medical advisor at Health Canada Dr. Supriya Sharma said at a public briefing on Nov. 26 that Canada plans to make a decision on the Pfizer vaccine around the same time that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency do.
Those decisions are expected to be made sometime in December, with FDA having set a meeting on Dec. 10 during which they will make a final call on the vaccine.
However, Health Canada has its own approval processes, designed to ensure vaccines are safe and effective.
Sharma said Canada’s review of Pfizer’s vaccine is the most advanced out of the current candidates, but still ongoing.
“While significant time and resources are being devoted to expediting the scientific review of COVID-19 vaccines, the decision on whether they will be authorized will ultimately depend on assessment of the data, including the complete information from clinical trials, which is still coming in,” Sharma said.
Sharma said Canada “will only authorize a vaccine if its benefits clearly outweigh its risks.”
“While we are working hard to give Canadians access to COVID-19 vaccines as quickly as possible, we will not compromise our safety, efficacy and quality standards. Protecting the health and safety of Canadians is our top priority,” Sharma said.
While Pfizer’s vaccine may be furthest ahead in Canada’s review process, AstraZeneca, Moderna and Janssen’s vaccine candidates have also been submitted to Health Canada for approval.
Pfizer announced in November that results of clinical trials that showed its COVID-19 vaccine was 95 per cent effective and offered “significant protection” for older people. However, the candidate needs to be kept at -70 C during transportation and storage to remain effective, posing logistical problems.
Infectious disease specialist Dr. Abdu Sharkawy told CTV’s Your Morning on Wednesday that news of Britain’s approving the Pfizer COVID-19 vaccine is “exciting.” He expects other vaccine candidates to be approved in Western countries in the coming weeks.
Sharkawy said the approval adds to the “sense of optimism” around a successful coronavirus vaccine.
“If the data has been looked at very carefully by one regulatory body, like the MHRA in the U.K., then certainly the FDA and Health Canada should be able to do the same thing,” Sharkawy said
“I would be surprised if Health Canada did not follow suit with approval very, very soon,” he added.
However, in a statement to CTV News, Pfizer Canada said on Wednesday that “an approval in one jurisdiction does not equate to an approval in another.”
Despite being approved in the U.K., infectious disease specialist Dr. Isaac Bogoch says Pfizer’s vaccine candidate won’t land on Canadian soil anytime sooner.
Bogoch told CTV News Channel on Wednesday that regulatory bodies are “working at different paces” and said the U.K.’s approval does not mean that Health Canada should rush its own decision.
“I really hope that they do their job in a very fair manner without any external pressure, and I really hope that it doesn’t push them to do their job faster,” Bogoch said. “If it’s a day, a week, a couple of weeks longer, [that’s] fine, as long as they do a thorough job and ensure that Canadians get access to safe vaccines that are effective.”
Bogoch explained that Health Canada not only has to look at the data from a vaccine’s clinical trials, but the agency also has to consider the manufacturing process of that vaccine.
Bogoch said it is likely that Health Canada will approve the Pfizer vaccine in the “coming weeks.” However, once the vaccine arrives in Canada, Bogoch said the country needs to have programs already in place to ensure the shots are immediately rolled out.
“It’s not quite clear when the vaccine will land on our doorstep but when it does, we better work really, really hard right now to sort out how we’re going to ship this,” Bogoch said, adding that Pfizer’s temperature requirements do pose a challenge.
“This is that one where it requires [-70 C] freezing, so the logistics of getting this around the country are hard. I hope that process is underway because we might get access to this sooner than we think,” he said.
Canada has secured access to a total of 414 million doses of COVID-19 vaccines from different sources including 76 million from Pfizer, but just four million of those are expected to land in the country by the end of March.
Deputy Chief Public Health Officer Dr. Howard Njoo said on Nov. 26 that while there will be early prioritization of who gets vaccinated based on the limited initial supply, Canada will have enough doses to “provide access to every Canadian who wants one in 2021.”
However, Kerry Bowman, a bioethicist and assistant professor at the University of Toronto’s faculty of medicine, says he is concerned that vaccine access may be limited throughout the next year if a proper rollout plan is not in place.
Bowman told CTV News Channel on Wednesday that there is “a lot of confusion and ambiguity” as to when provincial health authorities will have a COVID-19 vaccine so inoculations can begin.
Bowman’s remarks come on the heels of weeks of moving targets and changes in messaging from federal and provincial officials about Canada’s vaccine standing and timelines.
“So many of the people in Canada and the provinces, if they’re going to be prepared for this they do need dates and they do need numbers. How do you prepare without that?” Bowman said.
While he acknowledges that administering a vaccine nationally “isn’t easy,” he said there needs to be more transparency from government officials about current rollout plans to ensure that Canadians aren’t hesitant to get vaccinated once they can.
“We really, really need to build trust with Canadians right now so that when the vaccine is available that people are trusting of that,” Bowman said.