Vaccine nearing federal approval

Green light for first candidate could come within weeks,

A first COVID-19 vaccine 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 until that approval is secured, 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 scheduled for Dec. 10, 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 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 successfully approved a product Nov. 20, with a nod for an antibody therapy made by 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 first continue to simmer.

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.