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Canada AstraZeneca and Johnson & Johnson vaccines — where is Canada at on approvals?

00:35  26 february  2021
00:35  26 february  2021 Source:   globalnews.ca

Here’s what the provinces, territories have said about AstraZeneca’s vaccine and seniors

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Canadian officials continue to be vague on the potential approvals of two additional COVID-19 vaccines.

a close up of a bottle: (Left) AstraZeneca vaccine vials (right) Johnson & Johnson vaccine vials. (Getty Images/The Associated Press) © Provided by Global News (Left) AstraZeneca vaccine vials (right) Johnson & Johnson vaccine vials. (Getty Images/The Associated Press)

Vaccines by AstraZeneca and Johnson & Johnson are among those still awaiting a green light from Health Canada, but the shots are quickly picking up steam in other parts of the world.

With shortfalls in deliveries from vaccines already approved -- Moderna and Pfizer-BioNTech -- there is increasing pressure on the health agency to secure more options and get more shots into the arms of Canadians.

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But federal officials say they are confident there will be "more than enough vaccines" between contracts with Pfizer and Moderna to offer all Canadians a shot by September. The approval of candidates like AstraZeneca and Johnson & Johnson will be only a bonus to Canada's "suite of vaccines."

"As additional vaccines come online, there will be more opportunity, more options, more flexibility for provinces," Maj.-Gen. Dany Fortin, who is overseeing logistical planning for Canada's vaccine distribution efforts, said Thursday.

"As more vaccines come online, as the supply increases ... provinces will be able to vaccine at scale."

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Here's what we know so far about each:

AstraZeneca

Of the three vaccines submitted to Health Canada, AstraZeneca is the furthest along in the regulatory process. Still, the final stages of the approval process have stretched for weeks.

The U.K. and the European Union have already started rolling out the shots. The World Health Organization also gave the shot its approval this month, allowing vaccinations to begin in developing countries.

Health Canada has said the vaccine has been complicated to review because of a number of factors, including a mix-up in how big the doses were during the clinical trial and questions about how effective it is against new variants of the virus, particularly one first identified in South Africa.

South Africa has stopped using the vaccine completely, fearing it won't be enough to prevent people from getting sick from the B.1.351 variant, which is now the dominant virus there.

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Trial data surrounding the age of volunteers has also been a factor of concern to Health Canada, Dr. Supriya Sharma, Health Canada's chief medical adviser, said on Feb. 9.

Earlier this month, Health Canada said there has been some "back-and-forth" with the company to finalize the rules for how the vaccine is to be used and on whom.

The concern there lies in whether the vaccine was effective enough on older adults since the first two phases of its trials did not include people over the age of 65. Many European countries have only authorized it for use on people younger than 65.

The shot is less effective in clinical trials than its rivals -- 62 per cent versus high 90s -- but offers logistical benefits, including low-temperature storage.

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If approved, the authorization would set in motion an agreement for up to 20 million vaccines for Canada, though they're not expected to arrive until at least the second quarter.

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Sharma has insisted Health Canada's decision on the shot is "in the final stages."

"I don't envy Health Canada's position right now because I think they're in a very difficult position," Kelly Grindrod, a professor at the University of Waterloo's School of Pharmacy, told Global News in a previous interview.

"What we are seeing them do, though, is their job."

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Despite the seemingly slow pace, some experts have commended the national health agency for its meticulous analysis, saying it only emphasizes that safety is a top priority.

Dr. Howard Njoo, Canada's deputy chief health officer, emphasized that Thursday.  He said he had "no line of sight" in terms of the approval process but that Health Canada regulatory experts are doing their "due diligence."

"I think Canadians can rest assured that we have one of the most stringent regulatory processes in the world and that the safety and effectiveness of any vaccine or any product will have gone through a rigorous process."

Johnson & Johnson

It was expected AstraZeneca would be the third vaccine approved in Canada, but it now appears Johnson & Johnson could be moving ahead in line.

The one-dose shot also appears less effective than the mRNA vaccines -- 66 per cent in a large global trial -- but experts say it can still play an important role, as it offers strong protection against severe illness.

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This week, the U.S. Food and Drug Administration underlined those findings, saying the vaccine does, in fact, appear to be safe and effective. It paves the way for a final U.S. decision on issuing emergency use authorization (EUA) as early as the weekend.

Pending authorization, the U.S. expects to roll out three to four million doses next week.

Read more: Johnson & Johnson one-shot vaccine is safe, prevents COVID-19, U.S. FDA says

Canada has been somewhat in lockstep with the U.S. on COVID-19 vaccine approvals. Pfizer and Moderna are approved in both countries.

But neither Fortin nor Njoo could provide any further update on its approval process either.

Njoo said provinces and territories are thinking ahead -- planning how various vaccines might fit into their approach, based on their characteristics -- but that its approval would only be an addition.

"As additional vaccines are potentially approved in Canada, that can only add to the confidence Canadians have," Njoo said.

Canada has ordered 10 million doses from Johnson & Johnson. It also has the option of ordering up to 28 million more, if deemed necessary. The majority of those shots are expected to arrive by the end of September.

Like AstraZeneca, it has logistical benefits. The vaccine only requires a single dose and can be stored for months at refrigerator temperature, instead of the ultracold or frozen temperatures of others.

Unlike AstraZeneca, which has been approved in more than two dozen jurisdictions, only one country has approved Johnson & Johnson's vaccine. Bahrain approved the one-dose vaccine on Thursday. The small Gulf state already offers its residents Pfizer, AstraZeneca, China's SinoPharm, and Russia's Sputnik V vaccines.

--With files from the Canadian Press and Reuters

Anand won’t say whether Canada waived right to sue over vaccine delays .
More fulsome details of the European Union's contract with AstraZeneca show that the bloc waived the right to sue if deliveries of the vaccines under contract are delayed.In an interview with Global News Morning, Anand was asked what recourse the federal government has if it encounters delays to shipments of coronavirus vaccines such as those that dried up or severely reduced deliveries during the end of January and early February.

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