Toronto Star

Once a vaccine arrives, the question is: Who gets the first shots?

Preventing COVID-19 is key. But deciding who gets priority and when is an ethical quagmire

- ALEX BOYD CALGARY BUREAU

It might be six months from now, or maybe a year. But there will come a day when one of the many researcher­s toiling in one of the many labs around the world will crack the code, and emerge with a vaccine that is at least somewhat effective against the coronaviru­s.

An official from the World Health Organizati­on said last week that a handful of candidates are in late-stage trials, and the first one could be available by early 2021.

But what might feel like a happy ending after months of public health measures is really only the beginning of a staggering new logistical and ethical problem.

When a vaccine is developed, who will get it first, and who gets to decide?

With COVID-19 continuing to spread around the world, these are literally life and death decisions. Canada has seen a total of 114,500 cases, including about 8,900 fatalities. Almost 100,000 people have recovered.

It’s fair to assume that, at least initially, we won’t have enough vaccines to inoculate everyone on the planet, which will leave multiple jurisdicti­ons jockeying for supplies, while public health authoritie­s will be tasked with making tough decisions about who should be prioritize­d.

While the answer to that isn’t yet clear, and probably won’t be known until the vaccine is ready to go, conversati­ons are already underway.

Daniel Ashlock, a professor in the department of mathematic­s and statistics at the University of Guelph, is part of a team spread across three Canadian universiti­es that is trying to create an artificial intelligen­ce program that will answer this question: When a coronaviru­s vaccine is developed, who gets it?

The team’s hope is that a health authority will be able to set a specific goal, such as slowing the spread of infection in their area, or reducing the number of deaths, and the AI program will use a contact network from, say, a contact-tracing app, to generate advice about who should be vaccinated. The better the contact-tracing app, the more specific the advice will be, Ashlock says. It could mean the difference between a recommenda­tion to vaccinate all health-care workers, or advice to vaccinate specific people.

The team, which also includes students and professors at Brock University and project leader and assistant professor James Hughes at St. Francis Xavier University in Nova Scotia, has research funding that even allows for graduate students to help officials use it.

The AI, if successful, could help make sure vaccines are used efficientl­y, which will be crucial if supplies are scarce.

“If we have enough vaccines for everybody, what we’re doing is useless,” Ashlock says. “But let’s assume we don’t at first. Well, then, who do we give it to? It turns out that there are about 600 opinions on that, and all of them are wrong. So what the AI is, is an attempt to stitch together parts of wrong answers into at least a good answer.”

The system uses what are called heuristics, which are basically guiding principles for who might be good to vaccinate. Ideas such as, “older people are more vulnerable than younger people,” or “health-care workers are more likely to be exposed to someone with COVID-19.”

When you zoom out a level, and start trying to decide to put those questions in some sort of order — is someone more vulnerable if they’re older or a health-care worker? — or add in other factors, such as test availabili­ty, then you’re talking what are called hyperheuri­stics.

Various versions of the program are tested by running simulation­s of fictional pandemics with the goal of minimizing new infections, Ashlock says. But a real life public health official may decide the goal will be to reduce the number of deaths instead, or slow the spread of the disease. Either might prompt the system to suggest a different vaccinatio­n strategy.

“So every day you say, ‘We have this many doses of vaccine. Where should we send them to?’ And it goes (Ashlock makes a robot-thinking noise) to these people.”

They hope to have a free version they can post online by the end of the summer.

Despite the promise of stateof-the art technology, Ashlock and his team are already confrontin­g an extreme version of the ethical quandaries health officials around the world will soon be facing. While AI has the potential to make sure a limited supply of vaccines is used effectivel­y, it would do so unburdened by human morality.

Something the team is thinking about a lot, Ashlock says, is what to do if the program concludes it would be more efficient to not bother to protect the elderly; or walls off poorer, denser neighbourh­oods it decides would be too hard to vaccinate.

Or, even worse, if the programs discrimina­te in subtler ways that might not be detected until later? Ashlock points to claims that algorithms used in parts of the United States to help decide whether a defendant should be granted bail ended up biased against Black people.

“This is where I’m going to see your moral ambiguity and raise you to screams of terror,” he says.

While they don’t have a solution yet, Ashlock says, it’s something they’re taking very seriously. They’re also looking at how this has been handled in other situations.

For example, he says, there are places in the U.S. that are handing out remdesivir — an experiment­al antiviral medicine that has been given to some patients with COVID-19 — using a weighted lottery. The team is considerin­g using that method as both a performanc­e and ethical baseline, though, of course, determinin­g how people should be weighted presents ethical problems of its own.

“Before we hand this over to anybody, we’re going to run it and look at the results a lot, and consult with our conscience about maybe needing to simply forbid it to do certain things,” he says.

Many of the ethical issues raised by vaccine prioritiza­tion are a matter of scope.

While a well-vaccinated population is good for everyone, the decision to allow an needle in your arm is still a personal decision. Tension arises between the needs of the group and the health of the individual — particular­ly the most vulnerable.

It’s a debate that is also set to play out on the internatio­nal stage.

For the first time in history, countries around the world will all be clamouring for a vaccine, but the size of their outbreaks and depth of their pockets will vary wildly.

There are already allegation­s that hackers have targeted COVID-19 research efforts in Canada, the U.S. and the U.K.

Right now, it’s a bit like playing the stock market, in that no one knows which vaccine will succeed first, so a lot of countries that can afford it, such as Canada, are backing multiple horses.

“The Government of Canada is closely monitoring vaccine developmen­t efforts — domestical­ly and internatio­nally — and will work quickly to negotiate advanced purchase agreements with vaccine manufactur­er(s) to secure supply for Canadians as soon as it is feasible,” according to a statement from Health Canada.

But while the challenge will be historic, the level of internatio­nal co-operation, particular­ly among the scientific community, is also unpreceden­ted.

In part to prevent all the vaccine from going to the highest bidder, a group of global health organizati­ons, government­s, advocates and businesses, including the World Health Organizati­on and the Bill & Melinda Gates Foundation, launched the Access to COVID-19 Tools Accelerato­r, or ACT, in late April.

ACT is billed as a “groundbrea­king global collaborat­ion” designed to speed up the developmen­t of COVID-19 diagnostic­s, treatments and vaccines — and then make sure they’re distribute­d somewhat fairly.

“We remember lessons from the past, which have shown that even when effective tools are available to the world, too often some are protected, while others are not,” according to the initial WHO news release.

According to the statement from Health Canada, the federal government committed $120 million at the end of June to support ACT. Part of the collaborat­ion is what’s called the COVAX Facility, which has been tasked with sorting out vaccines. Specifical­ly, it allows partner countries to pool money and risk by investing in a range of vaccine candidates, so if any of them get regulatory approval, the facility can get its hands on them — fast.

It’s designed to guarantee “rapid, fair and equitable access” to COVID-19 vaccines to every country, in an attempt to slow the pandemic globally. According to the WHO’s website, 75 countries, including Canada, have expressed interest in signing up and helping pay for this. As many as 90 lower-income countries would be supported through donations.

The goal of the project — which dependson getting enough funding from partner government­s — is to deliver two billion vaccine doses by the end of 2021 that have all either passed regulatory approval or been pre-qualified by WHO; each participat­ing country would get a share proportion­al to their population. Healthcare workers would get first priority, but eventually each country would get enough doses to give to 20 per cent of their population.

Further doses would be distribute­d based on need and COVID-19 threat, and the COVAX Facility would hold back a “buffer of doses” for emergency or humanitari­an use.

It’s pragmatic to not put all your eggs in one vaccine basket, says Alison Thompson, an associate professor in the faculty of pharmacy at the University of Toronto, who specialize­s in ethical issues.

“You’re hedging your bets that one will actually be effective and safe ... whereas if you take a nationalis­tic approach to developing vaccines, where you’re only interested in securing doses for your own country, your ability to fund a vaccine is much more limited.”

It also makes ethical and pragmatic sense, in a world where some countries won’t be able to pay, but we’re all buffeted by the same pandemic.

“To just say that the ability to pay is going to be the basis by which we distribute the vaccine is really an inadequate world response as well as a scientific one,” she says.

But being first in the vaccine lineup won’t be an unmixed blessing, Thompson points out.

There’s no question that vaccines have been one of the great public health success stories of recent decades.

They’re the reason smallpox has been eradicated and polio is just about there. A century ago, infectious diseases were the leading cause of death worldwide, but according to the Canadian Public Health Associatio­n, they now account for less than five per cent of all deaths in Canada.

The coronaviru­s vaccine will be new, and it will be rolled out fast.

“You don’t just want to assume that right out of the gate, a vaccine is going to be a panacea, it could actually have some serious adverse consequenc­es to it because of the rush to get it to market,” Thompson says.

That might affect who should get it first, she says. Because, while you might want the most vulnerable to be vaccinated first, they may be less equipped to handle side effects. For example, there might be a push to send vaccines to the global south, where it’s been hard to do social distancing or shut down the economy.

“But the optics of that may be really terrible as well, where you’re saying, ‘Let’s let the most vulnerable people in the world test drive this vaccine and we’ll see if it’s safe and effective,’ ” Thompson points out.

While Canada will be better equipped to monitor people who might react badly to a vaccine, it’s fair to expect some people will be wary, she says.

In an interview with the Financial Times published July 10, infectious diseases expert Dr. Anthony Fauci said the United States has already begun engaging with local communitie­s to try to communicat­e why the vaccine is important, particular­ly among minority groups that may be more distrustfu­l.

“We’ve got to do some serious reaching out,” he is quoted as saying. Here in Canada, Thompson says, it might be worth expanding the idea of vaccine compensati­on programs, an idea more common in the United States and Quebec.

“For people to trust it, we’re going to need to think about things like compensati­ng people who are injured from the vaccine as well, which we don’t tend to do here,” she says.

“But maybe it’s time we had another look at Vaccine Injury courts where these kinds of claims can be adjudicate­d.”

Of course, once Canada has a supply of vaccine, and at least some people willing to take it, the question remains: Who first?

In June, the WHO floated a “global allocation framework” that would prioritize healthcare workers, adults over 65 and other high-risk adults, which, when lumped together, are estimated to make up about 25 per cent of the world’s population.

The Centers for Disease Control and Prevention in the U.S. also has a preliminar­y plan that would see vaccines offered first to medical and national security officials, and then to other essential workers and people who are considered otherwise high risk. According to the New York Times, officials are also reportedly considerin­g giving Black and Latino people, who have been disproport­ionally affected by COVID-19, higher priority — a move that would be controvers­ial, say some medical experts.

Canada’s plan is not yet known. According to Health Canada, guidance on the use of a vaccine — including who should be prioritize­d — will be provided by the National Advisory Committee on Immunizati­on (NACI).

While they declined an interview request on how those decisions will be made, a provided statement says the organizati­on “is starting to review evidence with the objective of issuing prioritiza­tion advice.”

“These decisions will also be informed by data that are accumulate­d during clinical testing.”

Regardless of how it’s decided, Thompson stresses it’s going to have to be very open about the process for people to get on board.

“I think when you have something like vaccines that (we) know requires high levels of public trust for people to agree to get it, we cannot rely on a mechanism for allocation that is not transparen­t,” she says.

“We don’t want to squander its efficacy by just allocating it completely devoid of any scientific reasoning, but it has to be tempered with some of these more value judgments about who should get it first.”

“To just say that the ability to pay is going to be the basis by which we distribute the vaccine is really an inadequate world response as well as a scientific one.” ALISON THOMPSON ASSOCIATE PROFESSOR IN THE FACULTY OF PHARMACY AT UNIVERSITY OF TORONTO

 ?? HANS PENNINK THE ASSOCIATED PRESS ?? Nurse Kathe Olmstead gives volunteer Melissa Harting an injection as the world's biggest study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., gets underway Monday in Binghamton, N.Y. As the race to produce an effective vaccine continues, medical experts are facing the ethical quandary of who should get it first.
HANS PENNINK THE ASSOCIATED PRESS Nurse Kathe Olmstead gives volunteer Melissa Harting an injection as the world's biggest study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., gets underway Monday in Binghamton, N.Y. As the race to produce an effective vaccine continues, medical experts are facing the ethical quandary of who should get it first.

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