Canada’s first vaccine approval could come before Christmas, chief health adviser says

OTTAWA — The first COVID-19 vaccine approval from Health Canada could come before Christmas, the agency’s chief medical adviser announced on Thursday.

Dr. Supriya Sharma said that the review of Pfizer’s vaccine candidate—which is one of three currently being assessed for safety by Health Canada—is the most advanced, and the agency is expecting to approve it for use in Canada along the same pre-Christmas timeline as the American and European health agencies.

Both the U.S. Food and Drug Administration and the European Medicines Agency have said they are looking at December approvals for the vaccine candidate made in partnership with BioNTech, which was the first out of the gate to report preliminary positive results and an over 90 per cent effectiveness. The FDA has its meeting to decide whether to give Pfizer’s vaccine the all-clear on Dec. 10.

“We are expecting to make a final decision on the vaccines around the same time,” Dr. Sharma told reporters during the first of what will be weekly public briefings on the status of procurement and rollout plans. “And then we’re going to have to figure out all of those shipments.”

Thursday’s briefing was focused on the procurement and regulatory process to approve vaccines in Canada, which has garnered a surge of interest among the public in recent weeks, as an effective immunization is seen as the way out of the COVID-19 pandemic.

Though, Deputy Chief Public Health Officer Dr. Howard Njoo emphasised that “the initial supply of these vaccines will be limited.”

Canada has secured access to 20 million doses of Pfizer’s vaccine, but just four million are expected to land in Canada by the end of March.

Dr. Njoo said 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.”

“We’re doing everything we can to give Canadians access to the safest, most effective COVID-19 vaccines in the world. Over the past several months, there has been a great deal of preparation taking place behind the scenes to ensure Canada is well-positioned to obtain COVID-19 vaccines and building on our well established systems,” Njoo said.

These 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.

Seeking to try to clear up where the discrepancies are arising between the various projections for approval and delivery timings, Sharma said that there are multiple layers to the process that are operating on their own—the regulatory review, the companies ramping up mass manufacturing, and countries preparing for shipments—that will affect each other.

“So we’re talking about January in terms of getting our first shipment in. If everything goes well and if it goes smoothly, it might be earlier. If there are hiccups or something else happens in the manufacturing process or the distribution process, it may be a bit later and that’s why… it’s really difficult to kind of pinpoint those dates,” she said. “There really are a lot of moving parts.”

As of Thursday, here is where things stand, based on the presentations from a table of federal heath and procurement officials.

REGULATORY PROCESS

The global search for a way out of this public health crisis has resulted in over 140 COVID-19 vaccine candidates currently in various stages of development, including 28 vaccines currently in phase-three clinical trials.

Canada has signed deals with seven vaccine manufacturers: Pfizer, Moderna, AstraZeneca, Sanofi and GlaxoSmithKline, Johnson & Johnson, Novavax, and Medicago.

Officials said Thursday that final agreements have been reached with five of the seven vaccine manufacturers it has deals with—Johnson & Johnson and Novavax outstanding—and through these deals Canada has guaranteed access to 194 million doses with the option to purchase an 220 million more, meaning if all vaccines pan out, we’d have access to 414 million doses.

Sharma said Thursday that the vaccine submission review process can usually take up to a year.

“Reviewing a vaccine submission can consist of hundreds of thousands of pages of data, taken on average 2,000 person-hours, each vaccine review typically involves a team of seven to 12 reviewers,” she said.

However, under an emergency order the agency has been able to expedite the authorization process. Health Canada will need to evaluate each candidate before it can be administered to Canadians.

This includes accepting rolling information as it comes in from the manufacturer, rather than waiting until the end of that pharmaceutical company’s study, which is what is making it possible for Pfizer’s approval to be just weeks away.

Sharma said Pfizer’s application for authorization is “the most advanced in the review,” but there are two other candidates also being reviewed: Moderna and AstraZeneca.

PRIORITIZATION PLANS

It’s expected that once a vaccine or vaccines are ready to be administered to Canadians, the initial supplies will be rationed and given to the highest-risk populations, such as seniors as well as health-care and essential workers.

According to the preliminary guidance issued by the National Advisory Committee on Immunization, prioritization will be based on three factors: the state of the pandemic when the vaccine is available; the supply available and number of doses required; and the risk-benefit analysis of key populations such as those who are at higher risk for adverse outcomes if they contract the novel coronavirus.

Njoo said Thursday that this guidance will be refined as more doses become available, but it’s possible that Canada could be waiting between approved vaccines to have access to enough doses to give to everyone who wants to be vaccinated.

Further, not all sectors of the population will be able to access initial vaccines due to the lack of research into the potential impacts on them, such as children and people who are pregnant.

Sharma said that generally speaking, the bar for safety is that the benefit has to outweigh the risks.

“For vaccines, it’s really important to remember that these are not like chemotherapy agents that are given to patients with cancer and so that you accept a certain level of serious adverse reaction like infections, or your hair falling out. These are given to healthy people so we really are looking at all that information up front,” she said.

MILITARY INVOLVEMENT

In addition to the needed regulatory approval, Canada needs to figure out how to biomanufacture elements of the vaccine, how to distribute those millions of vials, and how to oversee the on-the-ground administration of the vaccine.

Further complicating the tall task, a number of the vaccine candidates being tested—including the Pfizer vaccine— require two doses and must be stored at very cold temperatures.

“In a country as geographically large as ours, we can expect some logistical challenges ahead,” Njoo said Thursday, confirming what CTVNews.ca has already reported: that the Canadian military says it is making plans to play a role in the eventual rollout of vaccines nationwide.

The military already has members stationed within the Public Health Agency of Canada to help the vaccine rollout task force with a logistics plan. Work is also underway to establish a national operation centre to oversee distribution of vaccines.

In terms of distribution, the contract tender for a national shipping plan has been issued and more than 70 companies, including major cargo and airline brands have expressed interest in playing a role. Part of the government’s criteria is to have the ability for cold storage to preserve the millions of doses coming our way, and the ability to deliver to all regions in Canada.

STOCKPILING SUPPLIES

As well, officials said that staff overseeing the national stockpile of emergency health supplies has already received enough supplies like needles, alcohol swabs and gauze to administer 25 million doses, and those supplies are being sent out to the provinces.

The government is also working on procuring dry ice, and building on the nearly 130 freezers already procured to store vaccines at cold temperatures.

Procurement officials told reporters in the briefing that the government is currently looking at the delivery calendars within the various vaccine deals and are negotiating how quickly doses could be sent to Canada.

Njoo also spoke about a central “prepositioning mechanism” that would allow Canada to import and store vaccines in Canada prior to Health Canada authorization, which would facilitate a faster distribution to the provinces and territories, as soon as it is approved. This capability is not expected to be ready in advance of the first round of doses approved and sent to Canada.

Further, as Prime Minister Justin Trudeau highlighted earlier this week, Canada is at a “disadvantage” because Canada “no longer has any domestic production capability” to make our own and is relying on other nations who will be prioritizing vaccinating their citizens first.

Canada has begun funding domestic vaccine production capacity—including expanding a National Research Council facility in Montreal—however, the facilities are still being constructed, with a mid-2021 target now for being ready to produce 250,000 doses a month.

Moreover, the government doesn’t have any licensing agreements in-hand. In a recent statement to CTV News, AstraZeneca said that “after discussion with the government and our technical experts, we agreed that the fastest and most-effective option to ensure timely Canadian supply… was to leverage an existing supply chain that was already established and beginning the qualification process.”

Future briefings will cover the logistics, distribution, and allocation aspects of the rollout in more detail, the officials said.

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