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#COVID-19 vaccine tracker: A guide for Canadians

#COVID-19 vaccine tracker: A guide for Canadians
Canadians have watched with awe how the global scientific community came together with unprecedented speed to create, it would appear, multiple COVID-19 vaccines we hope will begin the end of this pandemic.

With more than a hundred vaccines in the works for months—and no way to know which would cross the regulatory finish line first—Ottawa hedged its bets by making advance-purchase agreements for a wide portfolio of vaccine candidates: Pfizer, Moderna, AstraZeneca, Medicago, Johnson & Johnson, Novavax and Sanofi count among the makers with whom the feds have done deals.

Here’s an update on where all seven of Canada’s vaccine hopefuls stand, how many doses the government has pre-ordered and how soon we might expect to get them.


Pfizer (U.S.)

Trials and approval

Pfizer concluded its Phase 3 study in mid-November.

Health Canada received its application for apporov on Oct. 9, 2020 under the department’s “rolling submission” program. The outcome of the application is pending, though Health Canada’s chief medical advisor, Dr. Supriya Sharma, told Maclean’swe are about to have a full clinical package” for review with respect to at least one of the three COVID-19 vaccine submissions currently underway. She later told reporters that Pfizer’s application had advanced furthest in the review process.

Efficacy

The company’s own analysis found this two-dose vaccine to be 95 per cent effective against COVID-19, starting 28 days after the first dose. 

Does it work well on the elderly?

The company says its efficacy was consistent across ages, genders, races and ethnicities. For people over 65 years old, it was reported to be more than 94 per cent effective.

Reported side effects

No serious safety concerns, Pfizer says. A few subjects reported being fatigued, some said they got a headache. 

Upsides/downsides

One challenge: the vaccine needing to be kept very cold before being injected: approximately -80 C. Otherwise, its components can reportedly break down, meaning they won’t be of much use. 

It’s one of many in development that require two doses, and that could add a layer of challenge, not least ensuring people come back for their second dose at the appropriate time.

How much we could get

Canada has an advanced-purchase agreement for 20 million doses, with the option to buy 56 million more. Since it is a two-dose vaccine, the initial order would be enough to vaccinate 10 million Canadians. 

How soon can we get it?

In a press release, Pfizer said it hopes to produce 50 million doses globally by the end of 2020. How many of those will get to Canada is another question, as the American company is applying for approval in multiple countries.

Sharma told Maclean’s that Health Canada hopes that by January, at the earliest, they’ll be able to start immunizing Canadians, but did not specify with which vaccine. 

Updated Dec. 1, 2020


Moderna (U.S.)

Trials and approval

The company posted a primary analysis from Phase 3, or large-scale efficacy tests on Nov. 30, with its final analysis expected to come soon.

Health Canada received its application for approval on Oct. 12, 2020 under the department’s “rolling submission” program. As far as how much data has been provided, Canada’s federal health department’s chief medical advisor, Dr. Supriya Sharma, wouldn’t get into specifics, citing confidentiality agreements. 

Efficacy

Based on its Phase 3 trial with 30,000 volunteers, the company says the vaccine has an efficacy rate of 94 per cent. 

Does it work well on the elderly?

Of the 30,000 Americans who participated in the trial—getting either the vaccine or the placebo—nearly a quarter were over the age of 65. None in the group receiving the vaccine experienced adverse events.

Reported side effects

Nothing serious in terms of safety, the company stated. Some subjects did report fatigue, muscle pain and joint pain after the second dose. The effects generally didn’t last long. 

Upsides/Downsides

It needs to be kept pretty cold for transportation and long-term storage, about -20 C, which could pose minor logistical problems—though Moderna says the vaccine can remain stable in the temperate of a standard fridge for about a month. 

Like Pfizer’s, Moderna’s vaccine is administered in two doses, requiring the extra step of tracking recipients to ensure they come back for a second dose. 

How much we could get

Fully 20 million doses, with the option to purchase 36 million more. The initial advance order would be enough to vaccinate 10 million Canadians. 

How soon can we get it?

It still needs the green light from Health Canada, but officials have said Canada could receive upwards of six million doses of vaccines by the end of March 2021, potentially one-third of them coming from Moderna.

As for fears that other countries will get it before us, Moderna’s chief medical officer told the Globe and Mail that doses of the first batch will be coming to Canada—albeit a small amount; he is “hopeful that you’ll see significant quantities coming to Canada [in the] first, second quarter of next year.”

Updated Dec. 1, 2020


AstraZeneca/Oxford (U.K.)

Trials and approval

The drugmaker AstraZeneca partnered with the University of Oxford for this vaccine, which is currently in Phase 3 for efficacy testing on a large scale. The company started to release interim analysis from its clinical trials in the U.K. and Brazil. 

AstraZeneca was the first to apply with Health Canada—on Oct. 1, 2020—under the department’s rolling submission program, but it’s not clear how close they are to providing all the necessary data. 

Efficacy

Some news reports said the vaccine had an efficacy rate upwards of 90 per cent, but that was from a smaller subset group that accidentally got a half dose initially, followed by a full dose a month later. 

Those who got two full doses reported an efficacy rate of 64 per cent. As such, the company reported an average efficacy rate of 70 per cent.

Does it work well on the elderly?

So far, the vaccine has showed promised regarding the immune response in elderly. 

Reported side effects

The company said there were no severe side effects; it has yet to release data on mild side effects.

Upsides/Downsides

The director of the Oxford University vaccine group called this the “vaccine for the world.” That’s partly because it’s low cost—about US$3 per dose, one fifth that of the Pfizer and Moderna vaccines —and because it can be stored at the temperature of a common refrigerator.

How much we could get

Canada signed an agreement in September for 20 million doses.

How soon can we get it?

The company has asked U.K. regulators to review its vaccine for emergency-use approval, but an exact timeline for Canada’s approval—especially given the uncertainty around the accidental dosing error—is hard to predict.

Updated Dec. 1, 2020


Johnson & Johnson (U.S.)

Trials and approval

The first Phase 3 trial started in September testing the efficacy and safety of a single dose of this vaccine. With that trial still underway, the company initiated a second Phase 3 trial in mid-November, this one exploring the results of a two-dose regimen.

Their application to Health Canada was received on Nov. 30.

Efficacy

Phase 3 data on efficacy is not yet available.

Does it work well on the elderly?

Awaiting Phase 3 results.

Reported side effects

Still waiting for more data on that. There was a pause in the trial for 11 days due to an “adverse event” in one volunteer—the specifics of which weren’t disclosed due to confidentiality agreements. But the Phase 3 trial resumed when, according to the company, they “found no evidence that the vaccine candidate caused the event.”

Upsides/Downsides

Johnson & Johnson seems to have a strong footing when it comes to manufacturing, and the company has repeated its astounding goal of producing more than 1 billion doses of its vaccine by the end of 2021.

How much we could get

In August, the company announced an agreement in principle with the Canadian government to supply up to 38 million doses.

How soon can we get it?

Until the Phase 3 data rolls in, which is expected in the first quarter of 2021, it’s too early to say.

Updated Dec. 1, 2020


Medicago (Canada)

Trials and approval

The company posted positive results for Phase 1 of its plant-derived vaccine in early November, and immediately announced plans to start Phase 2 and Phase 3 clinical trials.

Efficacy

Sufficient data from Phase 3 trials not yet available.

Does it work well on the elderly?

Sufficient data not available.

Reported side effects

The company reported no severe adverse events from its Phase 1 trials.

Upsides/Downsides

A company in Quebec would be producing this vaccine, suggesting it would go to Canadians first.

How much we could get

Canada has an agreement to purchase 76 million doses of the vaccine.

How soon can we get it?

The company says it plans to submit for regulatory review sometime next year.

Updated Dec. 1, 2020


Sanofi (France)

Trials and approval

The company’s candidate is presently in a Phase 1/2 clinical trial to evaluate safety. If all goes well, Sanofi hopes to start Phase 3 before the end of 2020.

Efficacy

We’ll have to wait for Phase 3 results before knowing.

Does it work well on the elderly?

Sufficient data not available.

Reported side effects

Sufficient data not available.

Upsides/Downsides

Unlike vaccines that need to be stored at super-cool temperatures, this vaccine candidate can be stored in a common refrigerator.

How much we could get

Canada has an agreement to receive up to 72 million doses.

How soon can we get it?

There’s still a ways to go for the clinical trials, but the company says if all goes well it plans to request regulatory approval in the first half of 2021.

Updated Dec. 1, 2020


Novavax (U.S.)

Trials and approval

The company recently completed the enrolment for its Phase 3 trial in the U.K., with plans to start other Phase 3 trials in the U.S. and Mexico in the coming weeks.  

Efficacy

Quite good in monkeys, it would appearData from Phase 3 is required to see how well it works on humans.

Does it work well on the elderly?

We’ll see. More than one-quarter of the Phase 3 volunteers will be folks over 65 years old.

Reported side effects

A preliminary study published in early September found no serious adverse effects. A couple of people reported a severe headache, fatigue or malaise.

Upsides/Downsides

There would be a lot to go around. The company says it has secured large-scale manufacturing to produce two billion doses annually come mid-2021.

How much we could get

Canada has an agreement in principle to buy up to 76 million doses.

How soon can we get it?

The company said in a press release that the U.K. could get the vaccine as early as the first quarter of 2021, and Australia in the first half of 2021. Canada was on the press release for its vaccine commitment, but there was no timeline offered for this country. 

Updated Dec. 1, 2020

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The post COVID-19 vaccine tracker: A guide for Canadians appeared first on Macleans.ca.

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