How COVID-19 vaccines are being approved in Canada

The approval of a COVID-19 vaccine in Canada could potentially bedays away with the initial supply to be limited to about three million Canadians, in the first three months of 2021. But what approval processes have thevaccines gone through? CBCexplains:

Is the approval process forthe COVID-19 vaccine different than for other vaccines?

Due to the immediate need for the COVID-19 vaccine, some flexibility has been introduced to the approval process. Typically, a vaccine manufacturer will do all their clinical trials, gather all their data, prepare a submission package and put that forward for approval, said John Greiss, a Toronto-based intellectual propertylawyer with Norton Rose Fulbright, who advises companies in the life sciences sector that are regulated by Health Canada.

"Health Canada will comment on it or ask for additional information and it will go back and forth until they come to a decision, he said.

But withCOVID-19, Health Canada has accepted what's knownas a "rolling submission."

"The new process allows for a company to start an application process, submit the information that they have available, as of that date and add new data and new information as it becomes available,"Greiss said

Supriya Sharma, chief medical adviser to Health Canada, said this enables the organization to start reviewing the potential vaccine and will shorten the overall review process"while still maintaining those same standards for the safety and the efficacy."

What's included in the submission?

That really hasn't changed, Greiss said. Vaccine manufacturershave to submitall of thescientific data that they have, which includes any kind of lab data thatdemonstrates how the vaccine works, any kind of clinical trial data that they have obtained, along with Phase 1to Phase 3clinical trial data.

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They also have to submit information aboutthe manufacturing process and standards and procedures that demonstrate they're meetinggood manufacturing processesin their facilities, Greiss said.

How is the vaccine reviewed?

One vaccinesubmission is hundreds of thousandsof pages long and can take,on average around 2,000person hours to review, Sharma said.For COVID-19, Health Canada is employing specialized teams of seven to 12 people who have experience in areas like toxicology, infectious diseases, clinical medicine, microbiology andepidemiology to review the vaccine.

"Each vaccine submission has its own team that's dedicated to it. And they will go through all of that information," she said.

Reviewers must confirmthere are no significant safety concerns, determine that the vaccine is able to prompt an adequate immune response in vaccinated people and showthat it can protect against disease, she said.

"We go through all of that to see if it actually meets our standards for safety, efficacy, quality," Sharma said.

"We need to make sure that the benefits of the vaccine outweigh the potential risks and that we know that it's being made at a licensed place that's up to standards and up to code."

Greiss said that during the review process, Health Canada officials might, for example,ask for further clarification about the clinical trial procedure, or how patients were recruited.

"Or if they see anomalies in the data, they'll ask the company to justify or clarify that information," he said."So there is still that back and forth in terms of Health Canadasort of digesting andanalyzing the data andthe company having to provide answers for that before they get an approval."

Are the vaccine manufacturing facilities inspected?

For manufacturing facilities around the world, not just for vaccines, but for medications as well, Health Canadahas entered into mutual recognition agreements with other regulators, Sharma said.

"We actually have sent our inspectors over to their country," she said. "They've sent inspectors over to our country. We make sure that our standards are the same, our processes are the same."

Every facility that manufactures vaccines needs to have an inspection before it's licensed. Andthere areongoing inspections to make sure standards are maintained, she said.

What are they looking for in these facilities?

They're looking at key factors, known as the four Ps, Sharma said.

• Product: What's being made there.
• Premises: There are verydetailed specifications on the facilities themselves. For example,special flooring and ventilationsystems have to be in place.
• Process: All the processesthat go into manufacturing the product.
• People: The qualifications and training of the people that work there.

All of those things are really important in terms of makingsure that standards are met, she said.