Will Canada have made at home COVID-19 booster vaccines in 2021? Expert says likely not

Individual receiving a COVID-19 vaccine. Courtesy: CHUM

As officials work to vaccinate the population against COVID-19, experts have warned that the virus could become endemic, meaning booster shots are likely going to be required to ensure long-term protection from the coronavirus.

Currently, all of Canada’s COVID-19 vaccines are coming from abroad, which means Canada has been at the mercy of a competitive global market and delays from manufacturers have impacted Canada’s ability to get shots into arms.

However, the federal government says it is also working to ramp-up Canada’s domestic vaccine manufacturing capacity.

In February, Prime Minister Justin Trudeau announced his government had signed a deal with Maryland-based vaccine development company Novavax, to produce it’s COVID-19 vaccine candidate at the National Research Centre’s Royalmount Biologics Manufacturing Centre in Quebec.

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During the announcement, Trudeau said Canada needs “as much domestic capacity for vaccine production, as possible.”

Will Canada have made-in-Canada vaccines from the NRC’s Royalmount facility by the time the population needs a COVID-19 booster shot?

Here’s a closer look at what’s going on.

Construction ‘on track’

In an email to Global News on Tuesday, a spokesperson for the NRC said construction for the Biologics Manufacturing Centre is happening “at an accelerated rate” and “is on track and proceeding very well.”

“Construction is on schedule to be completed by end of July 2021,” the email read. “Generally a new Good Manufacuting Practices facility can take two years or more to complete.”

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The agency added that once construction is complete, “several steps will be required before actual vaccine production can begin.”

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These steps include establishing a process to make the specific vaccine in the facility and ensuring the process will result in a specific vaccine with “precisely the same quality in every dose.”

It will then need approval from Health Canada.

Meanwhile, according to the Health Canada website, Novavax submitted an application for its COVID-19 vaccine in late January, and it remains “under review.”

The NRC said it is working “closely” with Novavax to “prepare for the production of the vaccine” at the centre, “including on the technology transfer, which is underway.”

“Engineering runs are targeted for December 2021 and production runs will follow once the vaccine candidate, the facility, and the production process receive the required Health Canada approvals.”

The NRC said once complete and certified, the centre will have a production capacity of two million doses of a vaccine per month.

“The actual number of doses will vary depending on the specific vaccine, the manufacturing platform and processes, as well as its yield,” the email said.

Is the timeline plausible?

Canada’s first COVID-19 shots were administered in December of 2020. Researchers suggest those who receive a vaccine will likely need a booster in approximately one year.

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Asked if he thinks Canadians can expect to see made-at-home booster shots at the end of this year, Robert Van Exan, president and owner of Immunization Policy and Knowledge Translation said he doesn’t think so.

He said the money from the government is to increase the size and capacity at the Royalmount facility to accomodate Novavax.

“They were hoping that it wouldn’t take as long because they had part of that facility already built and they would go into hyperdrive to do what they needed to do,” he said. “Could it be done by 2022? Maybe, but I think you’re pushing it.”

Ultimately Van Exan, who has 40 years experience working in the vaccine industry in Canada, said “later in 2022” is likely when we will see vaccines ready for use from the Royalmount facility.

While late 2020 seems far away, Van Exan said building a manufacturing facility from scratch is an even longer process which could take around five years to complete.

In part, he said, because it’s a massively expensive undertaking. But also because there is specialized infrastructure that needs to be built in to the building.

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Van Exan said this includes things like HEPA filters, a steam generation plant, a facility that produces sterile water, centrifuges, chromatography equipment and more.

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“Then, once the equipment is all in there … it would take a good six months to validate that equipment,” he said. “Because you have to prove that everything in that facility is validated and running exactly as it should in a vaccine plant.”

Moving forward

Van Exan said he “wouldn’t even be worrying about making a vaccine in Canada for this first round of inoculations and maybe not even for the boosters.”

“I would focus on what am I going to do in the future, because this is going to happen again,” he said of the pandemic.

He said what Canada should be focussing on is building ‘surge capacity.’

Van Exan said while Canada has the capacity to make vaccines, it was all being used to create shots that are equally important and needed.

He pointed to Sanofi which produces vaccines for childhood vaccines for Canada, the U.S. and other parts of the world.

“You can’t stop doing those immunization tests because you’ve got a pandemic or else you’ll have another pandemic on your hands,” he explained. “So what you really need is what we would call surge capacity or extra capacity on top of what you’re already doing.”

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One way to do this, Van Exan explained is by creating a year or two’s worth of stockpile of the vaccines routinely made at a plant. That way if it needs to pivot to create, for example, a COVID-19 vaccine, there would still be a comfortable supply of the other shots.

Another option, he said, is to build large-scale fill and pack departments onto existing vaccine manufacturing facilities, Canada could buy bulk vaccines from the U.S. or elsewhere and package them for distribution in the country.

Another way to ramp up surge capacity, Van Exan said, is to build “shell facilities.”

“One outfit in Switzerland came up with the idea of building vaccine factories, building the shell,” he said. “Building them with all of the steam and the air systems and everything that you would need complete in them, but don’t put any machinery in them.”

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He said the amount of time it would take to get one of the shell facilities up and running in a pandemic would be “somewhere between six to 12 months.”

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“This could be done when you’re doing your clinical (vaccine) trials,” he said.

In a previous interview with Global News, Dr. Isaac Bogoch, an infectious diseases faculty member at the University of Toronto said Canada’s lack of domestic vaccine manufacturing capability has been “highlighted as a health security threat.”

“And it is,” he continued. “But I don’t think that’s lost on the Canadian government and the local governments.”

He said the federal government’s investment in boosting domestic vaccine production is a “really good start,” but added that it will take “sustained investment over time” in both the manufacturing and innovation side of things.

“I don’t think you’re going to flip a switch overnight and all of a sudden re-create your vaccine creation and manufacturing capability.” he said.

Procuring boosters

If Canada won’t have domestic vaccine manufacturing capacity in time to produce COVID-19 vaccine boosters, where will the country’s supply come from?

In March, Health Canada confirmed to Global News that work is “underway to define our future booster needs, both in terms of quantities and the vaccine technologies on which to focus.”

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“Canada is in discussions with vaccine developers regarding plans for early and secure access to booster and variant vaccines when they become available,” the agency said in an emailed statement.

The federal government has also pledged $173 million to help Canadian Biotech company Medicago develop a vaccine and build a plant in which to produce it.

The company’s website, says it’s COVID-19 vaccine is currently in phase 3 clinical trials.

The website said “before launching a vaccine, it is essential to test its safety and efficacy during clinical trials.”

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“While standard vaccine development timelines can take five to 20 years, we plan to submit a COVID-19 vaccine to health authorities for regulatory reviews in 2021,” the company’s website reads.

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To date, more than 14.2 million doses of the approved COVID-19 vaccines have been administered across Canada.

According to COVID-19 Tracker Canada, 34.4 per cent of Canadians have now received at least one dose.

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