AstraZeneca vaccine still not approved by Health Canada

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My Rabson
The Canadian Press

The World Health Organization approved AstraZeneca’s vaccine on Monday. If Health Canada follows suit, nearly 500,000 doses could be shipped to Canada in March, as part of the global vaccine exchange program “COVAX”.

But Health Canada is still talking to the British company about clinical data from the COVID-19 vaccine “to complete its review,” said Kathleen Marriner, spokeswoman for the federal ministry.

While AstraZeneca was expected to be the third vaccine approved in Canada, it is now on the verge of being overtaken by that of the American Johnson and Johnson.

The US Food and Drug Administration (FDA) will meet on February 26 to decide whether or not to approve this vaccine and the European Medicines Agency plans to make a decision in early March. Health Canada is working with these two agencies to review vaccines.

“While each country makes independent decisions according to their own mechanisms, Health Canada follows roughly the same timelines as our major regulatory partners, once all the data necessary to make a decision has been received and reviewed,” said M^me Marriner.

Two more vaccines in the spring?

In addition to obtaining doses of AstraZeneca through COVAX, Canada purchased 20 million directly from the company; Ottawa also bought 10 million doses of the Johnson and Johnson vaccine candidate.

Shipments of these two possible new vaccines would begin this spring, if approved. No one has approved Johnson and Johnson’s vaccine yet, but AstraZeneca has been approved by more than two dozen states. Only Pfizer-BioNTech’s vaccine has been approved in more locations.

The FDA is awaiting the end of a clinical trial of AstraZeneca’s vaccine in the United States, but Europe approved it on January 29. This decision prompted Health Canada to argue that a decision would be announced “in the coming days”.

On February 9, Senior Medical Advisor at Health Canada, Dr Supriya Sharma, said the review was “in the final stages” to spell out the rules for how the vaccine should be used and on whom. A week later, there is no indication that the decision is imminent.

Dr Sharma explained that the vaccine had been complicated to review due to a number of factors, including confusion over dose sizes during the clinical trial and questions about its effectiveness against the new variants.

The variants?

Last week, South Africa completely stopped using AstraZeneca’s vaccine, fearing it might not be effective enough in preventing people from getting sick from the B.1351 variant, which now dominates infections. over there.

AstraZeneca was also asked about the effect of the vaccine in the elderly, with some fearing that too few people over 65 have been exposed to the virus after being vaccinated to be able to establish with certainty the protection offered by the product. Antibody tests, however, have shown similar immune responses in people over 65 than in younger people. The WHO approval this week also covers all adults.

As of Wednesday afternoon, nearly a million Canadians had received at least one dose of the vaccine, and 335,000 the second dose needed. But the UK has vaccinated nearly one in four people and the US about one in six.

Supply Minister Anita Anand told the Canadian Chamber of Commerce on Wednesday that the delivery delays had slowed the operation, but the worst was over.

“Canada will experience a very, very steep slope in the coming weeks and months,” she said.

Pfizer-BioNTech’s delivery times are now over, with 403,000 doses arriving this week and three million expected over the next six weeks. Moderna intends to ship nearly 1.5 million doses before the end of March. Together, these two companies must ship 20.8 million doses in the spring and more than 50 million in the summer.

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