TORONTO (CANADA) – Canada could approve one or more COVID-19 vaccines early in the first quarter of 2021. This approval would be under a new, accelerated process similar to the US emergency use authorisation, according to Health Canada, the country’s drug regulator.
As the system is new, it was not immediately clear as to how the process would be compared to the US regime.
However on Friday, Canada made its first authorisation under the new system, for Eli Lilly’s treatment bamlanivimab, just within two weeks after its US emergency was granted authorisation.
Health Canada said, “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. “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, however, the timelines would be more clear once vaccine makers’ applications were complete.
The new interim order system allows for rolling submissions, where filing of partial applications can be made by companies and then add to them as more data is available. Moderna, Pfizer and AstraZeneca began rolling applications in October.
According to regulatory documents, 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”.