Health Canada could approve AstraZeneca vaccine in coming days

By news staff

AstraZeneca could become the third COVID-19 vaccine approved by Health Canada.

The health agency says officials are currently completing its review of the submitted data and expects to make a decision on the authorization of the AstraZeneca vaccine in the coming days.

This comes as regulators authorized AstraZeneca’s coronavirus vaccine for use in adults throughout the European Union on Friday, amid criticism the bloc is not moving fast enough to vaccinate its population.

The European Medicines Agency’s expert committee unanimously recommended the vaccine to be used in people 18 and over, though concerns had been raised this week that not enough data exist to prove it works in older people.

“Health Canada is aware that the European Medicines Agency has recommended granting [sic] conditional marketing authorization for the COVID-19 vaccine manufactured by AstraZeneca and Oxford University,” they said in a statement.

“Health Canada has been reviewing this vaccine in collaboration with the European Medicines Agency (EMA) as part of the EMA OPEN process. This process makes it possible for trusted regulatory authorities outside of the European Union, such as Health Canada, to collaborate and share information throughout the scientific review.”

Health Canada says it has been reviewing AstraZeneca’s vaccine since it was submitted on October 1 and is “expediting the review of all COVID-19 vaccines.”

On December 9, Health Canada authorized the Pfizer-BioNTech COVID-19 vaccine. They subsequently authorized a second COVID-19 vaccine, on December 23, manufactured by Moderna.

The shot is the third COVID-19 vaccine given the green light by the European Medicines Agency, after ones made by Pfizer and Moderna. Both were authorized for all adults. The decision requires final approval from the European Commission, a process that occurred swiftly with the other vaccines.

“There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group,” the regulator said but added that “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.

“EMA’s scientific experts considered that the vaccine can be used in older adults,” the agency said.


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Many countries on the continent have been struggling to vaccinate people as quickly as Britain, Israel, the U.S., and elsewhere, and it was long hoped that the AstraZeneca shot would help speed things up at a time when countries face surging cases in a pandemic that has taken the lives of more than 400,000 people in the 27-nation bloc.

The EU bet heavily on the shot, which is cheaper and easier to handle than some other vaccines, with orders for 300 million doses to be delivered after authorization and options for another 100 million doses.

Emer Cooke, the head of the EMA, said it was “a real pleasure” to authorize the vaccine.

“None of them is a magic wand on its own, but together they provide tools and options to prevent different aspects of the disease,” she said.

While the AstraZeneca vaccine has been authorized for all adults in other countries, only 12 percent of the participants in its research were over 55 and they were enrolled later, so there hasn’t been enough time to get results.

But some doctors warned that restricting the vaccine’s use in older people might worsen the pandemic’s impact since older people have suffered more severe disease and died at a higher rate from the coronavirus.

In its decision on Friday, the EMA assessed four trials in the U.K., Brazil, and South Africa. The agency said the research showed the vaccine proved to be about 60 percent effective by reducing the number of people who got sick. The trials have not yet shown whether the vaccine can stop disease transmission.

A separate study testing the AstraZeneca vaccine in the U.S. is still underway.


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The AstraZeneca shot appears to offer less protection than the other two vaccines approved by the EMA, the Pfizer and Moderna shots, which showed roughly 95 percent efficacy rates.

Two more vaccine makers also recently announced results, with Novavax saying this week that its shot appears 89 percent effective based on early findings and Johnson & Johnson saying its long-awaited single-shot vaccine was 66 percent effective at preventing moderate to severe illness.

If those vaccines are eventually licensed, that could help alleviate the pressure on the world’s huge demand for the limited shots currently available.

The authorization of the AstraZeneca vaccine comes amid a bitter dispute between the drugmaker and the bloc after the company said it would sharply reduce initial deliveries from 80 million doses to 31 million.

Amid fears doses from AstraZeneca could be diverted outside the bloc, EU officials are expected to propose measures Friday that could be used to block vaccine shipments to non-EU countries.

The AstraZeneca vaccine has already been authorized in several countries, including Britain, India, Argentina and Mexico.

The World Health Organization is also reviewing it; a recommendation from the U.N. health agency would allow its purchase and distribution to developing countries from a global program known as COVAX.

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