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Jumat, 21 Mei 2021

Canada has ordered more than 400 million COVID-19 vaccine shots: Here's the progress report - CBC.ca

The race to vaccinate Canadians against COVID-19 has ramped up considerably in recent weeks as shots begin to flow to virtually all age groups nationwide.

Nearly 50 per cent of the population has had one dose, vaulting Canada near the top of the global rankings, but fewer than five per cent have had the two doses needed to build substantial immunity against the deadly novel coronavirus.

To vaccinate all Canadians, the government has signed contracts with seven different vaccine makers — six foreign, one domestic — with options to purchase more than 400 million doses.

Six months into the immunization campaign, some companies have already delivered on those contracts while others, like Medicago, Novavax and Sanofi-GSK, are in various stages of development. Some of these products won't be available until late 2021 at the earliest, leaving their role in Canada unclear.

Here's a look at where the seven companies stand in their efforts to produce and ship COVID-19 vaccines to Canada.

Pfizer-BioNTech

Pfizer, the workhorse of Canada's vaccination effort, has been arriving at a steady pace since March. The New York-based company idled its Belgian plant in January to revamp production lines to pump out many more shots to meet global demand, a necessary fix that temporarily brought shipments to a halt.

Since then, the company has been delivering its mRNA product like clockwork.

More than 15 million Pfizer shots have been distributed to the provinces and territories so far with at least two million more arriving each week until the end of July. There will be some extra doses shipped in June with deliveries rising to 2.4 million a week that month.

Canada has procured a total of 48 million doses from the pharmaceutical giant, enough to fully vaccinate 24 million people.

At least 18 million of those shots will arrive in the July-through-September period. The expectation is most of those shots will be used to administer second doses for the millions of Canadians who've already had a shot of this product.

Boxes containing the Pfizer-BioNTech COVID-19 vaccine are prepared in December to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant in Portage, Mich. (Morry Gash/The Associated Press)

Some provinces have already begun to detail when those second shots will be administered while others, notably Ontario, have said little.

Because it's the only product currently authorized by Health Canada for use among people aged 12 to 15, the Pfizer shot will be crucial in getting adolescents vaccinated ahead of a safe return to school.

As of this month, the company is now shipping shots to Canada from its Kalamazoo, Mich. plant, which is just 220 kilometres from the Detroit-Windsor border crossing. This means Canadian deliveries will be better protected against European efforts to control vaccine exports.

Moderna

The mRNA shot from this Massachusetts-based company is the second-most frequently used COVID-19 vaccine product in Canada. The company, which had never previously brought a drug to market, has had trouble meeting insatiable global demand for its product.

While Canada was among the first countries to sign a procurement deal with Moderna, the company has had to cancel shipments or punt deliveries to a later date as it struggles with production issues.

Moderna is reliant on third-party finish-and-fill companies to churn out its product and ship it overseas. (Tyson Koschik/CBC)

Because the U.S. government invested heavily in the early research and development of this product, Moderna had to send a certain number of doses to the American marketplace, an obligation that has resulted in reduced shipments to other countries.

The company, which has few facilities on its own, is reliant on third-party finish-and-fill companies to churn out its product and ship it overseas. There have been delays in the quality-assurance process because of a shortage of skilled labour in Europe.

The company was expected to send some 12.3 million doses to Canada in the second quarter, for a total of 14.3 million shots in the first six months of this year. However, that number is now in question.

The new military commander leading vaccine logistics signalled Thursday that fewer shots — potentially eight to 10 million less than planned — could be delivered next month because of ongoing delays with Moderna shipments.

There are already early signs that the company might not hit that target.

A staff member sets up an antibody production line at the Ibex building of Lonza, where the Moderna mRNA vaccine is to be produced, in Visp, Switzerland, last September. (Denis Balibouse/Reuters)

Speaking to reporters late last month, Maj.-Gen Dany Fortin, the military commander who was in charge of vaccine logistics before he was abruptly removed, said Moderna will come "as close as possible" to the number of doses it initially promised to deliver in the April-through-June period.

When asked if the company was still on track to deliver those 12.3 million doses, a spokesperson for Moderna told CBC News: "We remain in close contact with our federal government partners."

"Moderna continues to scale up vaccine manufacturing and remains fully focused on delivering vaccines to customers in Canada and around the world," said Patricia Gauthier, the general manager for Moderna's Canadian operations.

In all, Canada has ordered a total of 44 million doses from the company..

AstraZeneca-Oxford

Most Canadians are now familiar with the concerns raised about this product. While safe and effective, the National Advisory Committee on Immunization (NACI) has said the viral vector shot from AstraZeneca-Oxford is not the "preferred" product because of the risk of a very rare but serious condition that could develop after vaccination.

At last count, there were 21 confirmed cases of vaccine-induced thrombotic thrombocytopenia (VITT) among the 2.1 million people who've already had a dose. VITT is blood clots combined with low levels of blood platelets following immunization.

The provinces have stopped using AstraZeneca for first doses, but some 665,000 shots from COVAX, the global vaccine sharing alliance, arrived last week.

Dr. Theresa Tam, Canada's chief public health officer, has said these shots will be used for second doses. Early data from the United Kingdom suggest the risk of VITT after second doses of AstraZeneca is likely lower than the risk after first doses.

The vaccine maker recommends a four-to-12-week interval between the first and second shot. Research suggests waiting longer may actually produce a better immune response.

There should be enough AstraZeneca-Oxford vaccine on hand by Canada Day to vaccinate about 75 per cent of the 2.1 million people who've already received a first dose. (Jeff McIntosh/Canadian Press)

Beyond the recent shipment from COVAX, Canada is also set to receive at least one million doses from AstraZeneca itself before the end of June.

Between those two shipments, there will be enough product on hand by Canada Day to vaccinate about 75 per cent of the 2.1 million people who've already received a first dose.

Canada has ordered up to 10 million doses from AstraZeneca, so more shots are expected to arrive in the months ahead.

Canada has also purchased some 1.5 million doses of a product biologically identical to AstraZeneca but manufactured by the Serum Institute of India.

Because that country is in the throes of a deadly wave of new cases, the Indian government has blocked all exports. The institute has said it could resume global deliveries at year's end.

Johnson & Johnson

Like AstraZeneca, NACI has said the viral vector vaccine from Johnson & Johnson is less preferable than the mRNA products from Pfizer and Moderna.

But some experts have suggested this one-shot vaccine could be helpful in vaccinating more vulnerable groups who may be less likely to return for a second shot.

Canada received some 300,000 doses of the J&J vaccine in late April, but these products have not yet been shipped to the provinces because Health Canada has ordered the shots be quarantined.

Boxes of the COVID-19 vaccine from the U.S. pharmaceutical company Johnson & Johnson are pictured at a central vaccine warehouse in Germany. The vaccine only requires one dose. (Ronny Hartmann/dpa via AP Photo)

The regulator is verifying the safety of these doses because they were made at a Maryland plant that has had an uneven track record of producing vaccines.

Workers at Emergent BioSolutions inadvertently ruined 15 million doses of the J&J vaccine by mixing up materials intended for the production of AstraZeneca shots.

The U.S. Food and Drug Administration has since ordered the Baltimore plant to stop all production.

A sign outside the Emergent BioSolutions site in Winnipeg is pictured in February. During an appearance before a U.S. congressional committee this week, the CEO of Emergent said more than 100 million doses of Johnson & Johnson's vaccine are on hold as regulators check them for possible contamination. (Gary Solilak/CBC)

During an appearance before a congressional committee this week, the CEO of Emergent said more than 100 million doses of J&J's vaccine are now on hold as regulators check them for possible contamination.

Canadian officials have said very little about what work is underway now to ensure the shots we've received are safe.

Novavax

Another Maryland-based company, Novavax, has produced a vaccine that has shown a lot of promise in trial results. The shot, which is given in two doses, was shown to be 89.3 per cent effective at preventing COVID-19 in participants in its Phase 3 clinical trial.

Novavax has been submitting data to Health Canada on a rolling basis since January, but little is known about when the vaccine will be available. Multiple requests for comment from CBC News have gone unanswered.

Novavax has repeatedly pushed back production forecasts and has struggled to access raw materials and the equipment needed to make its vaccine.

Earlier this month, the company again delayed its timeline for ramping up COVID-19 vaccine production and said it does not expect to seek regulatory authorization for the shot in the United States, the U.K. and Europe until the third quarter of 2021.

The company has already started producing its shots ahead of regulatory approvals, with more than 300 people working around the clock at a Fujifilm Diosynth Biotechnologies factory in Billingham, England.

Medicago

The federal government has signed a contract with one Canadian company for vaccine doses, Quebec-City-based Medicago.

Last fall, Ottawa floated $173 million to help Medicago develop its COVID-19 vaccine and build a large plant to produce it.

On Tuesday, Medicago, which is developing the product in combination with GlaxoSmithKline (GSK), reported positive early clinical trial data on its plant-derived COVID-19 vaccine.

A Phase 3 trial for Medicago with 30,000 volunteers is already underway in Canada, the U.S. and the U.K., and it will expand to Brazil this week.

Medicago’s plant-based COVID-19 vaccine candidate is now in Phase 3 clinical trials. (Medicago)

A spokesperson for Medicago told CBC News they expect to analyze and publish the data in early summer, then make a submission for regulatory approval from Health Canada.

"Pending approval, we would then begin production," Alissa Von Bargen said in a statement.

If approved, the Medicago vaccine is likely to be the first COVID-19 shot produced in Canada. The bulk material will mainly be manufactured at Medicago's North Carolina facility, but the vials are filled and finished with the GSK pandemic adjuvant in Canada. An adjuvant is a substance used in vaccines to help aid in the immune response.

Canada signed a deal in October to buy 20 million doses of Medicago's vaccine, with an option for 56 million more. But most Canadians will likely be vaccinated before Medicago's shot is approved.

Sanofi-GSK

The two large pharmaceutical companies with major operations in Canada, GSK and Sanofi, co-developed a COVID-19 vaccine product but announced a "delay" last year after it failed to produce sufficient results in clinical trials.

The two companies have since restarted the trial process and are currently in Phase 2 of testing. The third and final phase isn't expected to begin for a number of weeks, meaning these shots likely won't be available for use until next year.

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Canada has ordered more than 400 million COVID-19 vaccine shots: Here's the progress report - CBC.ca
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