TORONTO (Reuters) – Canada could approve one or more COVID-19 vaccines early in the first quarter of 2021, under a new, accelerated process similar to the U.S. emergency use authorization, according to Health Canada, the country’s drug regulator.
An interim order signed by Canada’s health minister on Sept. 16 created an expedited, temporary review system for COVID-19 drugs or vaccines, which otherwise could have taken a year to evaluate.
Because the system is new, it was not immediately clear how the process would compare to the U.S. regime.
But on Friday, Canada made its first authorization under the new system, for Eli Lilly’s treatment bamlanivimab, just under two weeks after its U.S. emergency authorization.
Separately, in a statement late on Thursday, Health Canada told Reuters it was working to “align regulatory approaches” with international partners.
“It is important to note that requirements in Canada for vaccine approval under the Interim Order are comparable to those necessary for an Emergency Use Authorization (EUA) in the US,” said the statement. “Overall, there is good consensus among regulators globally with regard to data requirements for COVID vaccines.”
The statement said approvals could come early in the first quarter of 2021, but that timelines would be clearer once vaccine makers’ applications were complete.
Canadian officials said in October that the expedited process would likely take months, whereas normal approvals take about a year.
Health Canada had already approved one COVID-19 treatment, Gilead’s remdesivir, more quickly than that, citing the “high unmet medical need and emergency context of the COVID-19 pandemic.” It received Gilead’s application on June 19 and released its decision on July 27.
The new interim order system allows for rolling submissions, where companies can file partial applications and then add to them as more data is available. Moderna , Pfizer and AstraZeneca began rolling applications in October.
To grant approval, the health minister must find that the benefits of a new drug or vaccine outweigh its risks, while considering “the urgent public health need caused by COVID-19,” according to regulatory documents.
(Reporting by Allison Martell; Editing by Tom Brown)
