First COVID-19 vaccine submitted to Health Canada for approval
Posted Oct 2, 2020 7:14 am.
OTTAWA (NEWS 1130) – Health Canada has now received its first application for approval for a COVID-19 vaccine.
The application has been submitted by AstraZeneca, which is developing a vaccine in partnership with the University of Oxford. Health Canada officials say they will now be doing a rolling review of the testing data to make sure it meets the rigorous standards for approval.
In September, the Trudeau government authorized a rolling review process for COVID-19 vaccines. The process allows companies to submit data as it becomes available, which helps officials review the vital information quickly and speeds up the approval process.
Health Canada receives its first submission to approve a #COVID19 vaccine. Comes from AstraZeneca’s proposed vaccine being developed with Oxford University. Health Canada says a rolling review of the clinical data is beginning but can’t give a timeline on decision #cdnpoli pic.twitter.com/KtNWACTfQN
— Cormac Mac Sweeney (@cmaconthehill) October 2, 2020
Health Canada has not said how long the review for the AstraZeneca-Oxford candidate may take. However, a statement says Health Canada will not make a decision “until it has received the necessary evidence to support [the vaccine’s] safety, efficacy and quality.”
The federal government has already announced an agreement with AstraZeneca to secure 20 million doses of its potential COVID-19 vaccine, if it’s successful.
Several other similar deals have also been signed in recent months.
Health Canada says it expects to receive more submissions from groups conducting vaccine tests in the coming months.
AstraZeneca’s global COVID-19 vaccine trial was put on hold early last month after a volunteer came down with what was described as a “potentially unexplained” illness. The pause came just days after the company announced the vaccine had entered Phase III of its clinical trials.
Testing resumed shortly after, reports suggest.
