After eight long pandemic months, the prime minister called it a “light at the end of the tunnel,” while the head of a pharmaceutical giant hailed “a great day for science.”
Early results from Pfizer Inc.’s potential COVID-19 vaccine, hinting at as much as 90 per cent immunity, are being heralded around the world as one of the first major confirmations of global hopes that a vaccine will be possible, maybe in a matter of months.
There are significant caveats. The results, splashed online in a news release early Monday, have yet to be reviewed by the larger scientific community, and no one knows yet how long immunity created by the potential vaccine might last.
Still, hope has been ignited.
“It kind of switched me over from theoretical optimism to just optimism,” said Dr. Lynora Saxinger, an associate professor and infectious disease expert at the University of Alberta. “There have been good early signs from many other vaccine trials, but this is a larger data set with more results in more people. It is looking very good.”
Teams around the world have worked furiously for months on what would be a brand new vaccine, but Monday’s result put Pfizer, alongside German partner company BioNTech, long considered front-runners, solidly in the lead.
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a release.
So while the news is exciting, much work remains before Canadians get ready to roll up their sleeves.
Here’s what you need to know.
So is the vaccine ready to go?
Not really. While these results are promising, they’re just an early look at the results of the last stage of human testing. That testing has to finish — then the scientists at Health Canada have to go through everything and decide whether to approve it or not.
Speaking to reporters Monday, Prime Minister Justin Trudeau said he hopes to see vaccines “landing in the early next year.”
Despite chatter in the United States about whether a vaccine would be ready before the election, Canadian officials have long held that early next year is their best-case scenario.
But can we have it when it’s ready?
Some Canadians likely will, but not all of us.
Right now, Canada is entitled to 20 million doses of Pfizer’s vaccine — and each person would require two shots.
There are 37.59 million people in Canada.
Of note, the government said last month that negotiations for options for additional Pfizer doses were ongoing.
Pfizer’s is just one of the seven potential vaccines for which Canada has locked down advance purchase agreements, spending somewhere in the neighbourhood of $1 billion in total to secure access to more than 300 million vaccine doses, assuming all the front-runner vaccines are approved.
While the details of those individual contacts have been kept under wraps — government officials say the market is too competitive to tip their hands just yet — Trudeau said Monday that vaccines could be ready as soon as early next year.
Assuming that the supply of vaccines will be scarce, at least at first, a national advisory body has recommended that seniors, those at high risk and front-line workers be prioritized in the first round of vaccinations.
When we say these results look good, what do we mean?
It comes down to fairly basic math.
Pfizer began Phase 3, or the final stage of human testing, in late July. It enrolled more than 43,000 volunteers from around the world and gave half of them a vaccine candidate and the other half a placebo.
The participants then went about their daily lives and, eventually, 94 of them got COVID-19. The effectiveness of the vaccine was measured by comparing the number of infected people who had been immunized with the number who hadn’t.
“If they hit 94 cases and the vaccine is really 90 per cent effective, the simple math says there was less than nine cases in the vaccinated group and 85 cases in the placebo group,” explains Alan Bernstein, president and CEO of CIFAR, a Canadian-based global research organization, and a member of Canada’s COVID-19 Vaccine Task Force.
“So 85 versus nine. That’s obviously a statistically significant result.”
According to the study design, researchers plan to continue until they have 164 cases of COVID-19, which they expect will happen by the third week of November.
What do the results not tell us?
Thanks to a pandemic that has put most of the globe at risk, research on products related to COVID-19 is hurtling along, which is mostly good, but that has exacerbated what’s been termed “science by press release.”
To wit, Monday’s news came in the form of a news release, and not a scientific paper, as it might have in less urgent times.
It’s understandable that people would want to know these results as soon as possible, but it’s critical that companies still face the scrutiny of the scientific community, Bernstein notes.
“It’s important that it be subject to peer review and that the data be solid, so we don’t get our hopes up falsely,” said Bernstein, who, as a member of the task force, helped advise the government on which vaccines to buy — a list that included the Pfizer candidate.
Additionally, no one knows yet how long immunity will last, which is a question we may not even be able to answer at this point.
“When a kid gets a polio vaccine, they’re protected pretty well for life. So will that be true for this one? Or will we need booster shots every three months, once a year, every five years? We don’t know.”
What do we know about how this vaccine works?
The vaccine candidate is the product of a partnership between Pfizer, one of the largest pharmaceutical companies in the world, and BioNTech, a German biotechnology company that was founded a decade ago to develop new cancer treatments but has pivoted to COVID-19.
The candidate has been tested in thousands of people in seven different trials spread across seven different countries.
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The Pfizer dose is “not the world’s easiest vaccine,” as Saxinger puts it.
It requires more than one dose and has slightly more average side-effects — think a sore arm — than some of the others. (Pfizer says no serious safety concerns have been observed.)
As an RNA vaccine, it has to be stored at very cold temperatures, which is going to make it a challenge to distribute. All of that said, it seems to be far outstripping the global goal of a vaccine that is 50 per cent effective.
Could this vaccine get an emergency approval in Canada?
Pfizer says it’s already gearing up to apply for emergency use authorization to the American Food and Drug Administration as soon as testing is complete.
This is the process the U.S. has used to speed up new drugs and treatments for COVID-19 — it’s basically a loophole that allows American officials to put things on the market that haven’t been fully tested by justifying the need for quick action during a public emergency.
According to the New York Times, the U.S. has already granted more than 300 emergency use-authorizations for products related to COVID-19.
However, this is generally not how Canada operates. Instead, in order to speed up COVID-19 treatments, the minister of health signed a new order last month that allows Health Canada to prioritize applications related to COVID-19.
For example, it allows companies to allow for regulatory approval before testing is complete, so that government scientists can review their data as they go.
“Health Canada will have a look at it towards the end of this month or December, I imagine,” Bernstein said.
“Then they will either call for more data, or more analysis of the existing data or give it some kind of interim approval.”
What are vaccine experts watching here?
A lot of researchers are likely breathing a sigh of relief because Monday’s results are a vote of confidence for a couple of new vaccine-making strategies.
There may be a lot of ways to make a vaccine, but many of the leading contenders have one thing in common — they’re trying to trick the body into fighting coronavirus by teaching it to recognize the virus’s distinctive spike protein.
Think of the now-classic picture of a coronavirus — it’s an orb with a bunch of bits sticking out, otherwise known as spike proteins. Those are the arms by which the virus attaches to human cells, so, the thinking goes, if your body attacks those, you destroy its chance to infect you.
Pfizer’s results suggest that may be a winning strategy. “The spike protein is a good target. We’ve learned that today,” Bernstein said.
The second takeaway for experts is that the new vaccine technology that uses RNA — essentially tiny recipes that prompt your body to make little coronavirus proteins that teach your immune system to fight off future attacks — may work after all.
The technology has long been considered promising because of, among other things, how quickly you can make a vaccine, but there has never been one approved for human use.
“I think today is an important day for science and for humanity,” Bernstein said.
Does this mean the race for a vaccine is over?
Not by a long shot. Pfizer still has to be approved by Health Canada and, regardless, most experts maintain there is still an advantage to having a wide range of vaccines available.
Bernstein notes that was the whole strategy used by the Vaccine Task Force to begin with.
“It is actually very difficult to scale up the number of doses needed. Like, if you think about it, we’re trying to vaccinate essentially everyone, and vaccine manufacturing capacity has got certain limits,” Saxinger said.
“The more different types of vaccines that we have, the more different ways and places they can be manufactured, the better,” she said.
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