This is part of an ongoing series of stories — The Road to a Vaccine — that will look 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.
In an unprecedented bid to assure the public that the safety of any COVID-19 vaccine won’t be compromised, the heads of no fewer than nine biopharmaceutical companies have banded together to make a public pledge.
The companies signed a public letter Tuesday, vowing to uphold “the integrity of the scientific process” as their potential vaccines make their way through clinical testing and the regulatory approval process.
That rival companies racing against one another to develop a vaccine felt the need to speak with one voice is telling, observers said.
“I’ve never seen anything like it,” said Isaac Bogoch, an infectious diseases specialist at the Toronto General Hospital. “It’s kind of a sad reflection of the world that we’re living in now; but, on the other hand, it’s a positive step.”
With an election looming in the U.S., there have been concerns voiced there that political pressure could be exerted to expedite the testing process.
In an interview with the Financial Times last week, the head of the U.S. Food and Drug Administration said he was willing to fast track a vaccine — though he insisted it would not be to appease U.S. President Donald Trump. According to the Los Angeles Times, the Centers for Disease Control and Prevention had asked public health departments around the country to draft plans no later than Oct 1. to distribute a coronavirus vaccine in a matter of weeks.
But in Tuesday’s letter, whose signatories included Johnson & Johnson, Moderna, Novavax and Pfizer — all of whom have signed deals to supply Canada with eventual vaccines — stressed that “the safety and well-being of vaccinated individuals” is their top priority.
Not negotiable, according to the letter, were principles such as the ethical standards of clinical trials, making sure there is a sufficient global supply of vaccine, and ensuring that only vaccines that have been through a Phase 3 clinical study are submitted for approval.
The other companies that signed the pledge were AstraZeneca, BioNTech, GlaxoSmithKline, Merck and Sanofi.
Canada and the U.S. have purchase agreements with several of the same companies.
However, any vaccine coming to Canada would have to be cleared by authorities in this country.
Bogoch said there’s usually a lot of transparency to how a clinical trial is conducted. The protocol is posted online, and the final results are usually published in a peer-reviewed medical journal.
Independent governmental bodies — meaning Health Canada here or the FDA south of the border — will look at all the data themselves and decide whether they believe the drug is safe enough to roll out to their citizens.
“The whole point is it’s an independent body. But with COVID-19, there’s a lot on the line,” he said.
Bogoch said that so far Health Canada has been “pretty conservative” in terms of approving things related to COVID-19.
While that means treatments such as the drug Remdesivir — one of the only drugs used on patients with COVID-19 — have been slower to get a green light, Canada has largely avoided approving things that didn’t turn out to be that useful, unlike the U.S.
“The United States’ FDA approved many serologic tests very early on and, quite frankly, many of those tests were useless,” he said.
In other words, even if there are concerns raised about vaccines being deployed in the U.S., Canadians don’t necessarily need to be concerned.
“If there’s untoward pressure on the FDA and they rapidly approve, it doesn’t necessarily mean that’s going to happen in Canada,” he said.
In a statement, Health Canada said it is expediting the review of any COVID-19 applications in order to “facilitate earlier access” to a vaccine, but maintains that it “will not authorize a vaccine unless evidence demonstrates that its benefits outweighs the risks.”
When a COVID-19 vaccine does eventually get approval, buy-in from the public will be crucial.
“I know that there are many different opinions of the role of pharmaceutical companies in health care,” Bogoch said. “I think that these companies appreciate that there is a lot on the line here, and that for successful vaccine programs at a global level, the global population needs to have trust that these vaccines were created in a scientifically sound manner, and that the safety and efficacy results can be trusted.”
An Angus Reid poll released last month suggested that 46 per cent of Canadians will get the vaccine as soon as one is available. A third of those surveyed said they would eventually get it, but wait awhile; while almost a quarter said they either wouldn’t get it or weren’t sure.
The survey found that concerns about side effects and the vaccine’s effectiveness played a role in whether or not someone was willing to roll up their sleeve.
Bogoch said it’s not inherently bad that the hunt for a vaccine is moving so quickly.
The hunt has an unprecedented number of people focused on the same goal.
“When you have infinite resources at your disposal, and infinite brains at your disposal, it’s incredible how much work you can get done and how fast you can do it.”