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Coronavirus: Health Canada in ‘final stages’ of AstraZeneca COVID-19 vaccine review

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OTTAWA —
Health Canada is in its “final stages” of reviewing the AstraZeneca COVID-19 vaccine candidate, according to the agency’s senior medical adviser Dr. Supriya Sharma.

On Tuesday during a technical briefing, Sharma said that Health Canada is currently going back and forth with the pharmaceutical company about what information the label will include.

“That’s what we’re in the process of doing right now,” she said, adding that this process can take “some time” before finalizing the review, which has been conducted in collaboration with the European Medicines Agency.

Health Canada’s regulatory experts have been assessing the submission from AstraZeneca and Oxford University for safety and efficacy since Oct. 1, 2020. It’s a two-dose vaccine, which several other nations have approved for use, including Britain, Australia, and South Africa.

Sharma said that the review of the AstraZeneca vaccine has been more “complicated” due in part to the way the clinical trials were set up, noting that there is a trial ongoing in the United States.

As well, in recent days and weeks questions have been raised about the efficacy of the vaccine in certain circumstances.

For example South Africa has suspended plans to vaccinate its health care workers with the AstraZeneca vaccine after a clinical trial indicated it is less effective against the variant strain predominant in that country.

And, France has advised against administering the AstraZeneca vaccine to people under the age of 65, citing a lack of data.

Sharma said that while this information is taken into account, it isn’t delaying Canada’s process.

“As we’re getting new information certainly we’re incorporating it into that review, but that hasn’t extended our timelines. We’re just taking that information, and for example if there’s time when we’re waiting for the company to get back to us, we’re using that time to look at any new additional information that’s come through,” she said.

“The goal of course is to make sure that that review is independent, it’s science and evidence-based, and when we finally do have an authorization that whatever information that we have on that label as part of the product monograph, correctly reflects all of the science and the evidence.”

Should the AstraZeneca vaccine be granted regulatory approval, it would be the third vaccine deemed safe for use in this country, following the Pfizer-BioNTech and Moderna vaccines.

During his Rideau Cottage address on Tuesday, Prime Minister Justin Trudeau said that Health Canada officials are “working around the clock” on the AstraZeneca and other ongoing regulatory assessments. The agency is also currently evaluating the Johnson & Johnson and Novavax vaccine candidates.

Typically, the vaccine submission review process can take up to a year, but because of an emergency order, Health Canada has been able to expedite the authorization process. The order allows the agency to assess rolling information as it comes in from the pharmaceutical companies’ studies, rather than having to wait until the end of its work to begin reviewing the findings.

Canada has secured access to 20 million doses of the AstraZeneca vaccine, up to 38 million doses of the Johnson & Johnson vaccine, and up to 76 million doses of the Novavax vaccine.

The federal government has been aiming to have shipments of any newly-approved vaccines arrive in Canada as quickly as possible once Health Canada gives them the green light.

In the case of AstraZeneca, it’s possible that up to 500,000 doses of its vaccine could land in Canada before the end of March, according to Procurement Minister Anita Anand.



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