How the Liberals are bungling the vaccine endgame

Amir Attaran: Seven promising vaccine candidates are nearing the finish line. Why hasn't Canada locked down orders for them like our closest allies have?

In March this year, just as the COVID-19 epidemic was settling on Canada like a vulture, I wrote an article for Maclean’s predicting how it would end. I lamented that while there were already coronavirus vaccines for dogs, none existed for humans and “no miracle can bring that about this year.”

I’ve rarely been so happy to be wrong.  A miracle is underway.

Vaccinology has moved at breathtaking speed. What used to take years, usually over a decade, is unfolding in under 12 months. Researchers who don’t remember what a weekend is have taken research steps formerly as straight as a line of dominoes, and reorganized them into giant pyramids, the faster to make them fall.

The teams running clinical trials are spread over several continents, all working together, to hoover up more data faster. Yet nothing—truly nothing—about the exactitude of the clinical trials, or the attention to safety and results, has been made less thorough.The calendar has been cut, but not the corners.

Best of all, the results from phase 2 of these clinical trials are not just good; they’re fantastic. Already seven trial vaccines have moved into phase 3—the last phase—where researchers hope for data showing they protect people from infection or illness in the real world.

A few months ago scientists worried that a human coronavirus vaccine may not be possible. No more. Now the consensus is that one vaccine—and I’d venture probably more—will pass the finish line before the snow melts.

But wonderful as the scientific story is, it raises new problems. Let me explain how global science is on our side, but Canadian politics is poised to wreck us.

First, why am I so sure?

Three reasons: there are enough trial vaccines in the running, they are of very different yet promising technologies, and history puts the odds on our side.

All vaccines work on the same principle: they “prime”—basically, teach—the immune system to recognize and fight a known danger.

A good vaccine raises antibodies that stick to and neutralize the COVID-19 virus (called SARS-CoV-2). But because antibodies might last only a few months, a better vaccine also raises a longer lasting army of cytotoxic T-cells to locate and kill the body’s infected cells inside which the virus hides. Once taught by a vaccine the immune system can protect, but like brains it also can forget, which is why periodic “booster” shots may be needed.

Technologically there are several ways to prime. The old-school ways are to inject whole, killed SARS-CoV-2, or just purified pieces of SARS-CoV-2 (called “subunits”).  The immune system sees the enemy and reacts, but without illness because the enemy is not alive.

The cutting-edge ways are to inject either the bare genetic instructions (or “mRNA”) for a subunit, or to inject a harmless carrier virus (a “vector”, not SARS-CoV-2) which incorporates those genetic instructions. Either way your cells read the gene, and like a little factory, they manufacture the vaccine and deliver an immune response just as if you were infected by SARS-CoV-2.

All these approaches are being thrown at SARS-CoV-2. Three Sinopharm and Sinovac vaccines use whole, killed SARS-CoV-2. The Pfizer and Moderna vaccines use mRNA wrapped in oily nanoballs. The AstraZeneca and CanSino Biologics vaccines use a live adenovirus vector, although the former clearly outperforms the latter. With diversity comes options.

The phase 3 trials now underway will test whether these seven leading vaccine candidates really do reduce COVID-19 infection, illness or both, without dangerous side-effects.

I am extremely optimistic. Scientists’ early fears that people could recover from COVID-19, without immunity, and soon fall ill again seems to be the exception rather than the rule. There is also precedent in several veterinary coronavirus vaccines. The odds also appear on our side: using the example of immunological drugs (the closest proxy there is for just vaccines) anything that reaches phase 3 historically has a nearly a nearly a two-thirds chance of succeeding. With three different vaccine technologies in the running, we can estimate (crudely) that the odds of at least one succeeding are 96 per cent.

Can you bank on that figure? Absolutely not, because nature throws curveballs at scientists, and things can go sideways. But go ahead and sleep easy, compared to the insanely hard-working scientists who pulled off these miracles in record time.

How might a vaccine “protect”?

Three ways: by making you less likely to become infected with SARS-CoV-2, less likely to fall seriously ill with COVID-19, or less likely to spread infection to others.

Does it matter which of these benefits the phase 3 studies show? Sure, although anything on that menu sounds better than being sick or dead of COVID-19. A good vaccine will have one measurable benefit. A great vaccine will have all three. Again there is precedent: some existing vaccines fend off infection totally and break the spread (like for papillomavirus), while others permit infection but block serious illness (like for tetanus).

But beware: most successful vaccines are not 100 per cent effective. If you think vaccination makes you invincible enough to lick the elevator buttons, well, please don’t. Regulators in the United States, who tend to set the benchmark, consider that a COVID-19 vaccine is good enough if it is 50 per cent effective at preventing or reducing the severity of disease. That is an achievable goal during a pandemic, and Canadian regulators almost certainly would agree.

Much better would be a vaccine that is around 70 per cent effective, because that is enough to extinguish the pandemic in Canada—but only if everyone takes it.

We can be pretty sure that the vaccine’s effectiveness will vary depending on the person. A frustrating problem is that the elderly, who are most endangered by COVID-19, also have weaker immune systems that are harder to prime. While the research is not yet underway, eventually scientists will test whether a combination of two vaccines, using different technologies, outperforms just one. For now, any vaccine that regulators approve for COVID-19 will be worth having.

But will it be safe?

Yes, of course. As a scientist, I will gladly bet my life on it, and my kids’ lives too.

If you do not believe me, consider the alternative: the COVID-19 pandemic is the deadliest in a century. No vaccine will be approved by regulators if it has risks even a tiny bit as severe as COVID-19 itself. No vaccine will be offered to you before being trialled in tens of thousands of closely-watched volunteers, and before tens of thousands of scientists nit-pick the results. The odds of a prevalent, dangerous side-effect slipping by unnoticed are infinitesimal (although extremely rare side-effects can, because they are extremely rare).

Yet there is a fringe of anti-vaxxers out there, eagerly tearing into a future COVID-19 vaccine like Christmas has come early. So please let me be blunt.

Canada is not Russia. Justin Trudeau is not Vladimir Putin, who forced a dangerously untested vaccine onto the Russian people. Our government does not treat people like guinea pigs.

If you choose to avoid a life-saving vaccine fearing its unknown, undiscovered risks, that is as stupid as seeing a slippery banana peel on the sidewalk, and stepping into oncoming traffic to dodge it. It is as crazy as being offered a parachute as the airplane goes down, but refusing it because you fear getting tangled in the lines. Don’t be that idiot.

And if you are that idiot, then with all due respect: you are an awful Canadian. We are people who care for others, but some of us are ineligible for vaccination because of being pregnant, too young or having an incompatible medical condition. If you and others like you refuse vaccination, the pandemic can’t be extinguished to protect those Canadians—which is extremely selfish.

The internet is full of crackpot theories about vaccines causing autism (they don’t) or Bill Gates hiding microchips in vaccines to track people (great cannabis, eh?).  Since you’re reading Maclean’s you probably don’t believe this rubbish—but your friends and family might. If you know an anti-vaccinator, now is the time to intervene politely, because that kind of flat-earthism can hurt or kill them, and others too.

If you love your family and friends, then never—never—just smile and ignore it.

When will ordinary Canadians get vaccinated?

Assuming those phase 3 trials pan out, reckon on rolling up your sleeve in the first half of 2021. But also reckon that the vaccine is coming to Canada late: probably months later than the United States, the United Kingdom, Australia, and the 27 European Union countries.

Why? Because the Trudeau government dithered. When our closest allies put their money down and placed orders for over a billion vaccine doses, our government failed to keep up. The dithering went on so long that there is only one country left in North America or Western Europe that has not confirmed its order—and that’s Canada.

Staking out the back of the queue means that we might beg for a little vaccine in a hurry for our health care workers or most vulnerable, but come to ordinary Canadians, expect to wait.

If only we were the British. Not only did researchers at Oxford University invent a vaccine just three weeks after COVID-19’s discovery, but they have not slacked off and their phase 3 trial probably will be the first to the finish line (disclosure: my science doctorate is from Oxford and those are my colleagues).

Oxford also partnered with Cambridge-based pharmaceutical company, AstraZeneca, which is well into manufacturing 2 billion doses on spec that it admirably committed to sell without profit during the pandemic. Unlike Canada, Britain has the scientific agility and industrial might to pull off this homegrown solution, but it also has fail-safe backups: it has placed orders for six possible vaccines, nabbing 340 million doses for a population of 66 million.

Meanwhile, in Canada, the Trudeau government appears to have ordered zero doses, of zero vaccines, and has no plan to bring anything through a phase 1 clinical trial—never mind phase 3—before next April.

The Minister of Public Services and Procurement, Anita Anand, said on Aug. 5 that Canada “is extremely pleased to establish [vaccine] agreements with Pfizer and Moderna.” But weirdly she refuses to reveal how many doses or the price paid—details which other countries gladly reveal, or even brag about. The government claims to be “aggressively pursuing the purchase … of COVID-19 vaccines”—although clearly “pursuing” a purchase is different from making a purchase.

Asked last week if Canada has confirmed orders for vaccines and, if so, how many and at what cost, Anand stated: “Our government is actively negotiating with a diverse range of leading vaccine developers in order to secure a supply for Canadians as quickly as possible. Given the steep global competition, and in order to protect Canada’s negotiating position, it would be imprudent to provide specific details regarding pricing. I look forward to updating Canadians on our progress with respect to vaccine procurement and the number of doses secured as we move forward.”

Where this leaves Canada so far is without an actual purchase of any vaccine in any number of doses that the government will confirm. As for its nebulous agreements with Pfizer and Moderna, betting on those vaccines as a package is risky because both use near-identical mRNA technology and are likely to succeed—or, perhaps, fail—together.

So what explains the Liberals’ failure to firm up and announce orders for multiple, diverse vaccines, as our closest allies have?

In two words, incompetent nationalism.

Instead of racing to get Canadians a vaccine—any working vaccine during a pandemic—the Trudeau government is more interested in giving a leg up to Canadian industry. Incredibly Health Canada, which should be in charge of the vaccine drive, has been sidelined, to the point where it punts even basic questions about that effort to Innovation, Science and Economic Development Canada (ISED).

ISED meanwhile is taking advice from a COVID-19 Vaccine Task Force whose membership it hid for months. Nothing about the Task Force’s deliberations or advice is public. Three of the 12 Task Force members once worked for the Canadian branch of a single company (Sanofi) that is in the vaccine race but running far behind the leaders. One notes that he “currently consults for the vaccine community”.  One is a venture capitalist who focuses on drug discovery and development. Another member runs a company that makes machines to fill vials and syringes with injectable medicines—like vaccines.

I do not doubt that the Task Force members have relevant experience or training. The ISED minister, Navdeep Bains, has set up a “protocol” for its members to declare conflicts of interest, including financial ones, but government is keeping those declarations secret. They should be public, in the same way that medical and public health journals publish authors’ conflicts of interest in their pages. Just the fact that Canada knows of conflicts of interest, but is hiding them from view, rings like a noisy alarm.

The government is now chasing dead ends and putting the welfare of Canadian industry ahead of Canadian people. In the spring, Justin Trudeau personally touted a clinical trial partnership between Dalhousie University, the National Research Council, and China’s CanSino Biologicals—but that effort died because China’s government blocked it. The companies that have received financial support from the government include small firms that have never commercialized any drug or vaccine, or that are still not ready for even phase 1 trials.

On current schedule, the first phase 1 study may complete in April 2021, likely meaning that phase 3 (if it happens) would continue into 2022.
In other words: instead of placing orders with experienced, world-leading vaccine firms nearing the finish line of phase 3 trials—the surest, quickest way out of the pandemic, the Trudeau government is backing less experienced Canadian upstarts who are no further along than phase 1, in the hope that their baby steps succeed to rescue us.

This strategy is, to put it mildly, unwise.

I have a better idea. Because other countries have dibs on most, and probably all, of the first batch of vaccine, Canada must enlarge the current vaccine manufacturing capacity to get any in a hurry. Our government’s priority should be to negotiate with the vaccine companies for licenses that allow their products to be made in this country.

For example, the National Research Council knows how to make vaccines. Its brilliant scientists were the world’s first to fully deploy an adenovirus-vectored vaccine (for rabies) ahead of any pharmaceutical company. Why can’t the federal government seal a licensing deal with AstraZeneca to make its adenovirus-vectored COVID-19 vaccine for Canadians using the NRC’s equipment?  And why not also make some extra as a gift for people in poor countries who otherwise would get none?  After all, Justin Trudeau has written about “manufacturing and … leaving no one behind” himself.

It disappoints me that the dithering Trudeau government has failed to cinch any licensing deals of this kind, especially when Australia, Brazil, India, and Japan have. But what do you expect when the wrong government department is in charge, and minsters are taking advice from a secretive Task Force.

This is not my first time protesting that the Trudeau government bungled Canada’s COVID-19 response. But torpidly neglecting to line up vaccines while all our closest allies did so is a higher level of magisterial incompetence. Come the day that Americans, Europeans and others roll up their sleeves for the needle, as Canadians watch enviously on lockdown TV, popular fury across the political spectrum could topple this government. It would not be the first time in history a pandemic did so.