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First COVID-19 vaccine could be approved in Canada next month — on similar timeline to U.S.

A first could get Canadian regulatory approval by mid-December, officials said Thursday — putting this country on the same timeline as the United States.

Any vaccine must get the green light from Health Canada scientists before being rolled out in this country, and doses won’t be shipped here , Public Services and Procurement Minister Anita Anand had said last week.

The review process has already begun.

Health Canada’s chief medical adviser, Dr. Supriya Sharma, says federal scientists have been working closely with officials from the United States and Europe, and expect to reach a conclusion around the same time.

Of course, much is riding on the analysis of results, but officials from the U.S. Food and Drug Administration are currently reviewing the Pfizer vaccine candidate and a meeting with independent experts is , which, if successful, could pave the way for an emergency use clearance by midmonth.

“We’re basically looking at the same data packages, we have very similar authorization pathways that are available for public health emergencies,” Sharma said, adding that Pfizer is also furthest along in Canada.

“We’re expecting to make a final decision on the vaccines around the same time as both the U.S. FDA and the European Medicines Agency.”

If that timeline holds, it’ll be a validation of a new approval process that Canadian officials developed in the wake of the global pandemic specifically to speed up the availability of things that might treat COVID-19.

Review of new drugs can often take the better part of a year, so the government created what’s called an interim order, which came into force in September. It’s the equivalent to the emergency-use approval granted by the FDA, but while the Americans have handed out hundreds of speedy approvals, Canada’s process only saw its first approval last week.

The temporary system a product last Friday, with a nod for an antibody therapy made by U.S. pharmaceutical company Eli Lilly.

The government has ordered 26,000 doses of the therapy, which has shown promise in reducing hospitalization and emergency room visits for patients with COVID-19, with the first batches to be delivered in December.

The order allows the government to do things such as prioritize the review of anything related to COVID-19, and do what are called rolling submissions, in which companies report their results to the government as they do their testing, instead of waiting until the very end of their process to hand over data and test results. Pfizer, Moderna and AstraZeneca have all begun the rolling submission process.

Canada and the U.S. may be working on similar approval timelines, but questions about who will actually get initial doses .

Federal officials have long said that the first window for vaccine deliveries is the first quarter of 2021, though Ontario Health Minister Christine Elliott appeared to call that schedule into question Wednesday, saying she no longer had a guarantee that vaccines would be delivered then.

“This is very concerning,” Elliott told reporters. “It’s really incumbent on the prime minister to stand up for Canada.”

Federal officials are standing by their initial timeline, saying that five out of the seven advance purchase agreements, which are still dependant on a vaccine being approved, have been finalized.

Premier Doug Ford said he would raise vaccine deliveries with Trudeau during the weekly call with other premiers.

“We have a lot of questions to ask,” he added. “When and how much and what types. … We can’t be last in line around the world.”

Ford said Canada should have the facilities to make vaccines under licence to ensure a supply, given the “massive” pharmaceutical industry here.

“We have the know-how. There’s nothing we can’t manufacture here.”

Experts have said that Canada doesn’t currently have enough capacity to manufacture vaccines, particularly the Pfizer and Moderna candidates that employ new mRNA technology, which is why Canada has locked down deals to have doses delivered, rather than buying the licence to manufacture them here.

With files from Rob Ferguson

Bruce Arthur: Positive COVID tests at Thorncliffe Park school might tell us something. The Ontario government’s reaction might tell us more

Think of what you got away with when you were a kid, or what other kids at your school got away with. It could be elementary; it could be high school. When we grow up, some things happen that remain a secret.

Now think of schools today, and what is happening that we don’t know. Recent asymptomatic testing at Thorncliffe Park Public School of those subjects tested positive. There is more testing coming, in more hot spots. The principal wrote to parents and reassured them that the test positivity in the neighbourhood is 16 per cent. (As of Nov. 16. Toronto Public Health had Thorncliffe at 11.8 per cent.) This was repeated by the minister of education.

“I think it should be noted that the principal within the school had communicated that the positivity rate compared from the community to the school is quite vast, right?” said Minister Stephen Lecce. “So there’s something right happening in the context of the layers of prevention, and the fact that our staff, our students and parents are adhering to the public health advice. I accept that we still have work to do in the context of countering in our community.

“And it has to be said; I mean this morning, including the data points from Thorncliffe, 99.9 per cent of Ontario students are COVID-free. And that continues, I think to underscore the importance of following public health advice. And it really I think demonstrates the importance of keeping schools open, which is our plan for 2021.”

Some of that is clearly nonsense. Neighbourhood positivity is comprised of people with symptoms, or who have reasonable reason to think they’ve been exposed. This was a voluntary sample of asymptomatic people. You wouldn’t expect them to match up.

“That piece of data should not be thrown out there to make people feel better,” says Dr. Ashleigh Tuite, an epidemiologist and modeller at the University of Toronto who sits on the province’s volunteer science table. “It’s not at all comparable, and it’s highly misleading to say that it is.” She points out a comparable number would be a voluntary sample of asymptomatic people in the community.

Further, Lecce’s favourite talking point — saying 99.9 per cent of students in Ontario are COVID-free — was a vacant claim before they ran those 433 voluntary tests at Thorncliffe and found 19 extra cases; it is nonsense after.

We just don’t know. Children are at a higher rate than adults. A recent Nature Human Behaviour paper, released two weeks ago, examined 79 different jurisdictions and weighed of almost every intervention on how the virus was transmitted, and found closing schools was second only to cancelling small gatherings in terms of its impact.

And whether or not it was because the testing system all but blew up in late September, Ontario has not introduced surveillance testing, or even sentinel testing, that would tell us what was happening in schools. Contact rates have climbed, the virus has spread, and this province still has no idea where it’s coming from about half the time.

“The fact that you can go in and find all these cases, and then say we don’t think there’s a lot of transmission happening in schools, I don’t think you can say that with a straight face,” says Tuite. “You need to do more. You need to do more follow-ups in that particular school, and more broadly.

“But anyone who tells you either side of that question — anybody who tells you that no transmission is happening or tells you that schools are hotbeds of transmission — is not necessarily basing that on data.”

Tuite says the next step should be what the city of Ottawa does: retest the kids who were exposed to the asymptomatic carriers in five days, because that would give you a sense of whether it is spreading despite safety measures in schools. And while Toronto medical officer of health Dr. Eileen de Villa said it seemed the Thorncliffe cases could be traced back to families, Tuite points out that in asymptomatic cases you can’t peg infection date to symptoms. And since adults are more likely to get symptoms than children, you can’t discern the direction of infection without using serology testing.

“I think we need to do more testing in schools, to have a better idea of what’s actually happening,” says Dr. Janine McCready, an infectious diseases doctor at Michael Garron Hospital in East York, which has been a leader in reaching out to and protecting its community. “If you have one kid occasionally showing up with symptoms, versus if you have a school and you’ve got 10 kids showing up before they’re symptomatic, or as they have mild symptoms, or multiple introductions, then one of those is going to set on fire. Same as in hospitals.”

Even this exposure means 200 kids have been sent home to isolate for 10 to 14 days, and that’s with class sizes capped at 15 for junior and senior kindergarten, and 20 for grades 1-9, because Thorncliffe is a high-risk school. And while Toronto and Peel have gotten federal money for isolation hotels, the province has not funded isolation facilities for people who cannot isolate at home. There are a lot of families in apartments in Thorncliffe Park.

We could be doing better. There is , and hopefully more after that. What if we find out kids are spreading the virus more than believed? Could smaller class sizes be back in the news? Could there be more pressure on the province’s baffling lack of support for isolation facilities? In Atlantic Canada, schools close because of a handful of cases, because a handful of cases there is treated as an emergency. What else would be on the table, if Ontario finds out something it doesn’t want to hear?

Look, schools should be the last thing to close. But it sure feels like this province hasn’t wanted to know what’s happening in there. Maybe we didn’t want to know what we might find out.

Bruce Arthur is a Toronto-based columnist for the Star. Follow him on Twitter: