Health Canada reviewing application from European firm
AstraZeneca seeking regulatory approval for so-called ‘Oxford’ drug
This story is part of an ongoing series — The Road to a Vaccine — that looks at Canada’s quest to secure a COVID-19 vaccine amid the global pandemic, as well as the hurdles and history it faces to do so.
Health Canada is doing its first review of a potential COVID-19 vaccine nment in calls what the an federal “important govve step” on the road to acquiring a vaccine for Canadians.
The British-Swedish pharmaceutical company AstraZeneca this week applied for regulatory approval for its experimental v
Officially known as AZD1222, it’s become known as the Oxford vaccine, due to the company’s partnership with the British university.
But before you start rolling up your sleeve, it’s worth noting that approval is anything but certain and, even in a best-case scenario, still months away.
“This is an important step for Canada in its response to the pandemic, but it is just one step on the road to obtaining safe and effective vaccines,” Health Canada said in a statement Friday.
Canada currently has advance purchase agreements with six different companies, including AstraZeneca, that give this country a spot in line to buy millions of doses, if and when any of the vaccines prove sucac can
. But before a vaccine be considered for use in Canadians, it must pass a series hurdles.
First, the company and the researchers they’re working with have to do what’s called a clinical test. They test their experimental vaccine on a growing number of volunteers to make sure it’s safe, first off, but also that it actually does what it’s supposed to, and helps protect people from the coronavirus.
There are three phases to every clinical test, though some companies working on a vaccine are running multiple stages at the same time to try to speed things up. If a participant reacts badly to the vaccine, trials stop until it’s decided whethae the
or not the vaccine was problem.
By the final round, researchers are injecting thousands of people with their vaccine to make sure it works, but also to head off any major side effects.
AstraZeneca for example, is currently in the third phase of its testing. Its goal is to do tests on as many as 30,000 volunteers in approximately 100 trial sites, located in, among other places, the United States, the United Kingdom, Brazil and South Africa.
It hasn’t been all smooth sailing for AstraZeneca. The company recently had to put testing on hold after a participant in the U.K. fell ill with what was reported as an inflammatory condition called transverse myelitis. Although some testing has now resumed, it has raised questions about whether the company has now fallen behind.
According to an AstraZeneca spokesperson, the company expects to have results from both its phase 2 and phase 3 tests available later this year.
Once a company has its final results, it’s up to each individual country to decide whether or not it wants to approve the vaccine and make it available to its citizens. In Canada, that’s Health Canada’s job. It takes department scientists an average of 300 days to go through all the information, study results for a new drug, and decide whether to approve it.
But in September, the minister of health signed an interim order designed to speed up vaccines and other treatments for COVID-19.
One of the new things Health Canada is doing is called a rolling submission, which means that, instead of AstraZeneca having to wait until it has all its results before it applies for approval, it can apply now, and Health Canada will be able to monitor the company’s results as they come in.
The company’s candidate is what’s called a viral vector vaccine, because it uses a different virus to sneak a bit of COVID-19
enetic material into your body. In this case, it uses a weakened version of a virus that causes something like the common cold in chimpanzees, and the recipe of COVID-19’s signature spike protein. The hope is that this will teach your immune system to react to — then fight off — COVID-19.