Pfizer applied for emergency use authorization of its coronavirus vaccine with United States regulators Friday, days after the company said it finished its final round of human trials — with promising results.
Pfizer and its partner company, BioNTech, said the final data shows its vaccine is 95 per cent effective against the virus, with no serious safety concerns. But, the full results of its trial have not been released and must be peer-reviewed by independents scientists.
Even though the data is not available, the vaccine has been submitted to the U.S. Food and Drug Administration (FDA) for emergency use approval.
If it gets the green light, this does not mean the vaccine has full approval; the vaccine is only deemed “investigational” and can be given to people while studies are ongoing, according to the FDA.
This means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, the FDA said.
What about in Canada?
In Canada, Health Canada is in charge of reviewing and approving Pfizer’s coronavirus vaccine.
Pfizer applied to Health Canada for approval of the vaccine on Oct. 9, according to the department’s website.
Speaking at a media conference Friday, Minister of Health Patty Hajdu said Health Canada has a “rolling review” process for the vaccine. Meaning, Pfizer submits data to the department as it becomes available.
The rolling review process allows Health Canada to review the data right away as it continues to come in. This is in order to accelerate the process, according to the department.
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“The rolling review process is because the situation is urgent so that as soon as the data is available it can be quickly reviewed,” Kerry Bowman, a professor of bioethics and global health at the University of Toronto, said. “But there is no way they are cutting corners on this. They are looking at all the evidence section by section. I find it very encouraging.”
He said so far Health Canada is still reviewing Pfizer’s Phase 3 trials, but there is a chance more information about the data will come in December.
“They are balancing safety and trying to keep things going as quickly as possible,” he said.
Does Canada have an ’emergency authorization’?
Health Canada does not have an emergency use authorization like the FDA. However, it has a review process that is comparable.
It’s called the “Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.” It was signed by the minister of health on Sept. 16, 2020.
The interim order allows “expedited authorization” for the importation, sale and advertising of drugs used in relation to coronavirus.
So, instead of a company, like Pfizer, providing substantial evidence of the safety and effectiveness of a new drug — as usually required by federal law — the interim order says an applicant can submit the information as it becomes available, allowing for the “rolling review” process.
This allows for a faster approval process during a health crisis.
“This new rolling review process under the IO (interim order) involves reviewing all the necessary data to support authorization in the context of the pandemic and urgent public health needs, and can shorten the time it takes for a new drug to be authorized once all of the necessary data are available,” Health Canada told Global News in an email.
Once a company submits new data, Health Canada said it starts the review “immediately.”
Under the interim order, a coronavirus drug is approved by Canada’s ministry of health once evidence shows the benefits outweigh the risks.
In order to be approved, the vaccine goes through a rigorous review process in Canada, despite the expedited timeline, Dr. Supriya Sharma, the federal department’s chief medical advisor, previously told Global News.
Under Canada’s system, three federal scientific teams review a vaccine prior to approving or rejecting it. Sharma explained that one team looks at pre-trial research on animals, a second team reviews human clinical trials, and a third team reviews the manufacturing process.
Sharma also said that the department’s review of potential COVID-19 vaccines will be “the same as with any other vaccine.” So if the department determines a vaccine candidate doesn’t meet the standards, Health Canada will not approve it, she said.
Following the authorization of any vaccine submission, Health Canada said it will also publish the evidence it reviewed in making its decision for transparency purposes.
How Canada’s vaccine approval differs from the U.S.
Health Canada said the requirements for vaccine approval under its interim order are similar to the FDA’s emergency use authorization — but there are some differences.
One important difference is that the FDA has been reviewing aspects of Pfizer’s data that Health Canada hasn’t seen yet.
Because Pfizer’s vaccine clinical trials took place in the U.S., Health Canada said U.S. regulators were able to review data such as the “quality” and “manufacturing” details, for several months.
“These trials were not carried out in Canada, therefore Health Canada will only have access to key data once they are filed under the IO,” the department said.
But Health Canada said it has been in “continuous contact” with Pfizer on the progress of their studies and filing plans.
Both the FDA and Health Canada have set up systems that safely allow ways to dramatically speed up the process for COVID-19 vaccines. This is because the normal approval process of a new vaccine can take about a decade.
An exact timeline of vaccine approval is still unclear in Canada, but last week Prime Minister Justin Trudeau said he hopes to have the vaccine available in early 2021.
If the vaccine is approved, Canada has an advance-purchase agreement for 20 million doses. The vaccine requires two doses.