Health Canada received more Johnson & Johnson data on same day as US approval

0


Health Canada received additional data needed to inform its decision on the COVID-19 vaccine from Johnson & Johnson on Saturday – the same day the vaccine was approved in the United States.

“We were waiting for manufacturing data, and it happened yesterday. So we’re starting to look at that, ”said Dr. Supriya Sharma, Chief Medical Advisor, Health Canada, on Sunday. Rosemary Barton Live.

“It’s really hard to predict exactly when we might make a final decision, because it really depends on that data. But we’re looking at… the next two weeks.”

The data received on Saturday is what health regulators need to ensure that “every dose of vaccine that comes off the production lines meets quality standards,” Sharma wrote in an email to CBC News.

The approval timeline depends on this information, but it also depends on whether regulators should discuss the issues that arise with the manufacturer. Work in the final stages of the review – including finalizing a risk management plan for post-authorization vaccine surveillance – also needs to be completed.

The two-week approval target takes those steps into consideration, but does not take into account any unexpected issues that may arise, Sharma said.

The government approved the use of a third vaccine, the Oxford-AstraZeneca vaccine, on Friday.

WATCH | Johnson & Johnson vaccine approval could come in the coming weeks:

Health Canada’s Chief Medical Advisor Dr Supriya Sharma said the agency is waiting for manufacturer data to make a decision on Johnson & Johnson’s single dose COVID-19 vaccine, but based on that data, approval could come in the coming weeks. 9:23

Single dose injection facilitates deployment

In a global trial, the Johnson & Johnson vaccine, which was approved by the U.S. Food and Drug Administration (FDA) on Saturday, was found to be 66% effective in preventing moderate to severe disease and 85% effective in preventing moderate to severe disease. prevent the most serious results.

Canada has ordered 10 million doses of the vaccine, with options for up to 28 million more.

The best vaccine for an individual is [the] the one you can get.– Dr. Supriya Sharma, Chief Medical Advisor, Health Canada

“In terms of the committee meeting organized by the FDA, we also had observers, so it all contributes to a more efficient review,” Sharma told CBC chief policy correspondent Rosemary Barton.

Although the vaccine has been approved as a single-dose regimen, the company is also testing the effectiveness of administering two doses of its product.

“If a vaccine is just one dose, it makes it easier to administer. You don’t have to follow up to register people and find them to get the second dose,” Sharma told Barton. “So that all helps, but what really helps the most is to get as many vaccines licensed and get that supply as fast as possible.”

Not a question of “ good ” and “ bad ” vaccines

Now that more vaccines are gaining approvals, Sharma said a “narrative” has emerged where people assume that one vaccine gives better protection than another.

Efficiency, she said, simply means determining whether “something is doing what it’s supposed to do.” When it comes to COVID-19 vaccines, this means comparing a group of people who received the vaccine against another group of people who did not and comparing the number of cases in the two groups.

“When we look at all the vaccines, the top five that are being reviewed and licensed, if you look at the subsection that matters the most – serious illness, hospitalizations, deaths from COVID-19 – all of those vaccines are protective too. , ”Sharma explained.

The chief medical adviser warned against one-on-one confrontation, which she said can only happen in a “one-on-one” trial, which would see two vaccines tested together in the same trial.

“The best vaccine for an individual is [the] the one you can get. It’s pretty straightforward, ”she says.

“For people who are sitting and waiting for another vaccine, I would say that the longer and more people who are doing it, the more we will all be sitting at home if we are lucky to have a home. “

You can watch full episodes of Rosemary Barton live on CBC Gem, CBC’s streaming service.



Source link

Share.

About Author

Comments are closed.