Need to 'walk before we can run' with vaccine rollout, says Pfizer Canada president
Pfizer Canada president Cole Pinnow hails Health Canada's 'historic' approval of Pfizer-BioNTech vaccine
Cole Pinnow, president of Pfizer Canada, says the company will start shipping doses of its COVID-19 vaccine Friday, to arrive in Canada a few days later.
"This is historic. We couldn't be more proud that Pfizer and BioNTech were able to bring to Canada the first COVID-19 vaccine," Pinnow told Matt Galloway on CBC Radio's The Current.
"We think this represents a monumental change in the way that we are fighting the pandemic, and hopefully represents the first big step towards normalcy," he said.
Health Canada approved the Pfizer-BioNTech vaccine Wednesday for people over the age of 16, after a review of the company's clinical trial data. Its authorizing report found that "the data provided supports favourably the efficacy of Pfizer-BioNTech COVID-19 vaccine as well as its safety." It is not known how long the vaccine's protection from COVID-19 will last.
Watch: Vaccine is a 'monumental' shift in fight against COVID-19: Pinnow
Canada is the third country to authorize its use, after the U.K. and Bahrain. The Food and Drug Administration will meet Thursday to discuss the vaccine, with vaccinations possible in the U.S. as early as Dec. 12 if it's approved.
On Monday, Prime Minister Justin Trudeau announced that 249,000 doses of the Pfizer-BioNTech COVID-19 vaccine were on track to be delivered this month, enough to vaccinate roughly 125,000 Canadians with the two doses required.
The following day, U.S. President Trump signed an executive order to restrict exports of vaccines from the U.S., but Pinnow said that won't affect Canada.
"We're shipping this product from Belgium, and so we feel confident that we can provide this product in December to Canadians," he said.
"We're still assessing the executive order, but we are committed to honouring our contractual commitments to Canada."
Following the Health Canada announcement Wednesday, Trudeau tweeted that 30,000 doses are expected to arrive in Canada on Monday.
Update on Pfizer-BioNTech’s COVID-19 vaccine that was just approved by Health Canada: 30,000 doses are expected to arrive as early as Monday at the 14 points of shipment across the country. Up to 249,000 doses are coming this month, with millions more in the new year.
—@JustinTrudeau
Pinnow said the vaccine will initially be delivered directly to 14 sites across Canada, with doses divided up on a per-capita basis among the provinces.
Because the vaccine must be kept close to -70 C, Pinnow said efforts have been made to ensure appropriate delivery and storage.
"We're working with those point-of-use sites very closely to ensure that they have the dry ice capabilities and other training materials necessary to handle the product," he said.
"This is the most valuable product in the world right now. And it would be a shame to lose a single drop because of the newness of handling the product," he said.
Shipping frozen products is something Pfizer and other pharmaceutical companies do "every single day," he added.
The shipping containers are equipped to be used as interim storage devices, with software that monitors temperature, and GPS trackers that transmit their location. Each container can hold up to 975 doses.
He said there would be a phased approach to expanding distribution as more doses become available, but "we want to walk before we can run."
WATCH: Pfizer addresses vaccine concerns
Concerns over speed of development
Under normal circumstances, the development of a vaccine can take years — a fact that has prompted concern over the speed at which vaccines for COVID-19 have progressed.
Pinnow tried to assuage those concerns, reassuring "Canadians that the scientific rigour and regulatory oversight that went into this product is as robust, if not more robust, than any other vaccine that's been brought to market."
"The vaccine reacts, in the body, as we've observed, very similar to any other vaccine. There's going to be a little bit of pain on injection, some soreness, maybe some mild temperature, maybe a headache, but that's very common with all vaccines," he told Galloway.
WATCH: Health Canada discusses allergic reactions to the Pfizer vaccine
Documents submitted by Pfizer to the FDA show that four out of 18,000 people in the vaccine group of clinical trials reported experiencing Bell's palsy, which causes a temporary weakness or paralysis in muscles in the face.
"I can appreciate the concern, but I'm going to defer to scientific experts that look at the data in totality," said Pinnow.
"From what I understand, they say that that incidence is on par with the normal population and therefore isn't considered to be statistically significant."
Review faster than expected
Pfizer and BioNTech's development timeline was accelerated by moving to clinical trials sooner — forgoing extra time that would have been spent on formula development. That affects things like the shelf life of the vaccine, which is six months for Pfizer-BioNTech, as opposed to the industry standard of two years.
More time spent in that early stage would also have meant the vaccine could be stored at a higher temperature than -70 C, Pinnow said.
He said it was a conscious decision to instead move ahead to a clinical trial, with 44,000 participants.
When it was sent for review to Health Canada, that process too was expedited by sharing the company's clinical data as it became available, rather than waiting for a complete data set to be collected.
WATCH: Health Canada calls Pfizer approval a 'critical milestone' in fight against COVID-19
Pfizer signed a deal for 20 million doses (and an option to buy 56 million more) with the federal government in August, with an expectation that Health Canada's approval could come in early 2021.
Pinnow said it was clear by November that the review process was moving faster than expected, and the approval date could move forward "without compromising the scientific integrity and regulatory oversight that Health Canada was providing."
He said the federal government approached Pfizer to discuss and agree "what conditions would be necessary for us to change the timeline and be able to accelerate that to a December delivery."
Pinnow added that Health Canada is empowered to speak to other regulatory bodies internationally, "to cross-check and validate that they have as much information as possible to make a very informed decision."
Health Canada is also reviewing three other vaccines, from Moderna, AstraZeneca and Jannsen.
Shot offers relief to front-line workers: Pinnow
Pinnow said he won't get early access to the vaccine, and will wait until the most vulnerable have received it.
"When the general Canadian population has access to the product, then I will certainly get in line and get my Pfizer shot," he said.
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When pressed as to when that might be, he deferred to the prime minister's estimate that it might be September before all Canadians have had an opportunity to be vaccinated.
"We're really taking it week by week with each of the point-of-use sites, expanding the number of point-of-use sites from there, and trying to accelerate deliveries as soon as we're able to," he said.
He said he's most excited about "being able to provide relief to the nursing homes and the front-line workers who have been most at risk."
"We've all, as you said, been personally impacted by COVID-19 in one way or another," Pinnow told Galloway.
"But to bring them near-term relief, to help them have the confidence of protection going forward as they continue to battle this disease, as we scale up distribution, that really is the most heartwarming to me."
Written by Padraig Moran. Produced by Julie Crysler.