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Approval of a COVID-19 vaccine in Canada could potentially be days away with initial supply limited to around three million Canadians in the first three months of 2021. But what approval processes have vaccines gone through? CBC explains:
Is the approval process for the COVID-19 vaccine different from that for other vaccines?
Due to the immediate need for the COVID-19 vaccine, some flexibility has been introduced in the approval process. Typically, a vaccine manufacturer will perform all clinical tests, collect all data, prepare a presentation package, and submit it for approval, said John Greiss, a Toronto-based intellectual property attorney and Norton Rose Fulbright. , which advises businesses in life. science sector regulated by Health Canada.
“Health Canada will comment or ask for more information and will go back and forth until they make a decision,” he said.
But with COVID-19, Health Canada accepted what’s known as “continuous submission.”
“The new process allows a company to initiate an application process, submit the information it has available, starting from that date, and add new data and information as it becomes available,” said Greiss.
Supriya Sharma, Chief Medical Advisor for Health Canada, said this allows the organization to begin reviewing the potential vaccine and shorten the overall review process “while maintaining the same standards of safety and efficacy.”
What is included in the presentation?
It hasn’t really changed, Greiss said. Vaccine manufacturers must submit all scientific data in their possession, including any type of laboratory data that demonstrates how the vaccine works, any type of clinical trial data they have obtained, along with Phase 1 and Phase clinical trial data 3.
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They also need to provide information about the manufacturing process and the standards and procedures that prove they meet good manufacturing processes in their facilities, Greiss said.
How is the vaccine reviewed?
A vaccine submission is hundreds of thousands of pages long and can take, on average, about 2,000 person hours to review, Sharma said. For COVID-19, Health Canada is employing specialized teams of seven to 12 people who have experience in areas such as toxicology, infectious diseases, clinical medicine, microbiology, and epidemiology to review the vaccine.
“Each vaccine presentation has its own team that is dedicated to it. And they will go through all of this information,” he said.
Reviewers must confirm that there are no significant safety concerns, determine that the vaccine is capable of stimulating an adequate immune response in vaccinated people, and demonstrate that it can protect against disease, he said.
“We look into all of this to see if it actually meets our standards of safety, efficacy and quality,” Sharma said.
“We need to make sure that the benefits of the vaccine outweigh the potential risks and that we know that it is manufactured in an authorized location that is up to the standards and up to the code.”
Greiss said that during the review process, Canadian health officials could, 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 will ask the company to justify or clarify that information,” he said. “So there is still this back and forth in terms of Health Canada digesting and analyzing the data and the company has to provide answers for that before it gets an approval.”
Are vaccine manufacturing facilities inspected?
For manufacturing facilities around the world, not just vaccines, but drugs as well, Health Canada has mutual recognition agreements with other regulators, Sharma said.
“We actually sent our inspectors to their country,” he said. “They sent inspectors to our country. We make sure our standards are the same, our processes are the same. “
Any facility that produces vaccines must undergo an inspection before obtaining a license. And inspections are underway to make sure the standards are being maintained, he said.
What are they looking for in these structures?
They are looking into the key factors, known as the four Ps, Sharma said.
- Product: what is produced there.
- Background: There are very detailed specifications on the structures themselves. For example, special floors and ventilation systems must be installed.
- Process: all the processes that go into the production of the product.
- People: the qualifications and training of the people who work there.
All of these things are really important to make sure the standards are met, he said.
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