Canada will be among the first countries to receive modern COVID-19 vaccine shipments

Canada will be among the first countries to receive vaccine shipments from Moderna, the biotech company’s chief medical officer said Monday, amid questions about how quickly the country will be able to administer COVID-19 vaccines to Canadians.

The U.S.-based Moderna also announced Monday that it is seeking approval for emergency use of its vaccine from U.S. and European regulators. But it is not yet known how long it might take Health Canada to approve Moderna’s vaccine and other COVID-19 vaccines that the federal government has ordered.

Tal Zaks, Moderna’s chief medical officer, told The Globe and Mail that Canada would receive doses from the company’s first batches of vaccines and anticipated that the country would receive larger shipments by the first part of 2021.

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“I hope you will see significant quantities arriving in Canada [in the] first, second quarter of next year, “he said.” Those first batches will be small initially and it will take some time to scale up and accelerate our global production capacity. But we will do our best to provide this highly effective vaccine to as many people as possible. Canada is in the front row. “

Moderna is among the manufacturers of the major candidate vaccines with which Canada has procurement agreements. Canada has agreed to purchase 56 million doses from Moderna and 20 million from Pfizer. But questions about when and how these vaccines will be distributed to Canadians have sparked criticism from the federal government for lagging behind other countries in producing detailed vaccination plans.

On Thursday, Deputy Chief of Public Health Howard Njoo said Ottawa was expecting a total of six million doses from the two companies by March, pending approval from Health Canada. Since each vaccine is given in two doses, this would be enough for three million Canadians.

In his primary efficacy analysis of his phase 3 study, Moderna said in a press release on Monday that, based on 196 COVID-19 cases among the 30,000 study participants, he estimated his vaccine was 94 effective. , 1% against COVID-19 and 100 percent. one hundred effective against serious diseases. It also claimed that it has not identified any security issues to date.

The emergency use authorization the company applied for in the United States comes in the wake of a similar application from Pfizer. Officials from the U.S. Food and Drug Administration have said that if issued, this type of authorization does not amount to regular approval and that companies will be required to continue studying the performance and safety of their vaccines. Emergency use is generally only permitted when it is determined that the benefits of vaccine administration outweigh the risks. People in the United States who receive an emergency licensed vaccine must receive a fact sheet describing the experimental nature of the product and may choose to decline it.

In Canada, both Moderna and Pfizer vaccines are currently being considered as part of an ongoing submission process that allows regulators to review vaccine data while clinical trials are still ongoing.

In this way, “we can begin the review with the hope that it will help find some efficiencies in the overall process,” Supriya Sharma, chief medical advisor at Health Canada, told The Globe.

Steven Hoffman, director of the Global Strategy Lab and professor of global health, law and political science at York University in Toronto, said the regulatory approval process is unlikely to present a major obstacle in Canada. Instead, he said, the main question will be how quickly companies can produce vaccines.

“Production will be the limiting step,” said Dr. Hoffman.

Since the federal government has placed orders for major vaccine candidates at a relatively early stage, Canada should be in line with other rich countries to be the first to receive them, he said.

Dr Hoffman said what is worrying is the poorest countries, which have not been able to place vaccine orders and therefore will receive the vaccines much later.

“This will eventually create inequalities that will be felt in every country in the world because, of course, we live in a globally connected world,” he said. “So when some countries are left behind, it ends up creating ripple effects that affect us all.”

Joel Lexchin, a pharmaceutical policy expert and professor emeritus at the University of York Health Faculty, said it’s important for Health Canada to do its own reviews, rather than just following US or European approvals.

Following his own approval process, “he can independently evaluate the information presented and perhaps draw his own conclusions,” he said.

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