Vaccine confronts humanity with next moral test

THE CORONAVIRUS PANDEMIC has stress-tested the world. Beyond challenging human fortitude, national health services and international rivalries, it has forced a series of moral choices. Many have provoked impassioned disagreement — over whether governments can force businesses and schools to close, over sacrifices for the sake of the elderly and, most bitterly and surprisingly, over whether being asked to wear a simple face mask infringes individual liberty.

The toughest moral test lies ahead. The biomedical industry and research facilities around the world are progressing toward creating a vaccine that would offer the best chance to end the pandemic and return life to normal. But the moral dilemmas provoked by the development and distribution of a vaccine will drive ever deeper debates.

The issues strike at profound divisions between schools of ethics. The newly published The Ethics of Pandemics, an anthology edited by philosophy professor Meredith Schwartz of Ryerson University in Toronto, presents contrasting views of academics, doctors, and commentators along with a series of impossibly difficult case studies. The scientific, economic and political choices involve moral issues that have divided ethicists for centuries:

HOW TO DEVELOP IT?

The US government says the COVID-19 vaccine will be developed “at warp speed.” But vaccines take years to develop, for good reasons, and none of the benefits can be realized if they are released before they are safe. A failed COVID-19 vaccine could even compromise confidence in other vaccinations, threatening a return of measles, polio, and other plagues.

Testing shortcuts are available but fraught. The first rule of deciding when they’re justified, explains Arthur Caplan, the head of bioethics at the NYU Langone hospital system in New York, is that risks can be balanced against the prospect of better data. Thus, skipping animal testing may pass muster since the data from testing humans is better.

That leads to the issue that divides teams at Moderna, Inc. in Boston and at Oxford University in England who are working on the two most promising attempts to find a vaccine. How much risk of harming humans can they justifiably take? The best way to accelerate the process could fall afoul of the long-established obligations of medical ethics, from the Hippocratic oath to “do no harm.”

That pledge is as old as ancient Greece, it aligns with Christian teaching, and with the powerful school of rightsbased philosophy identified with the 18th century German philosopher Immanuel Kant, which holds that people should never treat humanity as a means to an end. Whatever the ultimate positive consequences, Kantians argue, there is no right to harm anyone. Virtuous ends do not justify unethical means.

In “human challenge trials,” which have been used to test cholera and dengue vaccines, volunteers are injected with a vaccine and then deliberately infected with the germ that researchers are hoping to neutralize. The subjects are tightly monitored, and results are available within weeks. Researchers at Oxford are developing strains of the coronavirus in preparation for such a trial alongside a much larger conventional study, as are the National Institutes of Health in the US. Such a study will require 150 volunteers at the most.

Moderna opted against human challenge trials, and instead started a conventional trial with 30,000 test subjects in July. Volunteers are given either the vaccine or a placebo, and then go about their daily lives as the pandemic rages. Moderna hopes to have scientifically reliable results by the end of the year.

Tal Zaks, Moderna’s chief medical officer, said he expects this approach to reveal how the vaccine behaves with different groups of people and in different regions. By testing in the real world, he said, results can be superior to the outcome of challenge tests, which are held in laboratory conditions.

But the conventional approach is slower, and leaves much to chance. Oxford’s attempt to hold such a study in London and Oxford earlier this year came just as the epidemic was beginning to decline in the UK, making it hard to draw firm conclusions. A rival research team at Imperial College, London, has the same problem and is looking to hold a trial in another country.

Further, doctors are morally obliged to tell volunteers how to avoid getting infected. They cannot tell them to go maskless, or to seek out crowded spaces, even though from a narrowly scientific point of view this would improve their test results. It’s also impossible to monitor so many volunteers closely enough to determine if they are reporting their experiences inaccurately and skewing the results.

Rutgers University bioethicist Nir Eyal says that coronavirus challenge testing in the US could simultaneously “maximize utility and respect rights.” Researchers would use only “informed, willing, low-risk volunteers” from a population that is already in high-risk areas, he said.

Volunteers are abundant. An advocacy group called 1 Day Sooner has found 32,000 volunteers in 140 countries, mostly between the ages of 20 and 30 (old enough to consent but much less exposed to serious harm from COVID-19 than their elders) with no relevant underlying medical conditions. Strongly believing in effective altruism, Josh Morrison, who heads 1 Day Sooner, voluntarily donated one of his kidneys to a stranger, as did others helping with the campaign.

But Kantian objections are serious. Michael Rosenblatt, a Harvard Medical School professor and former chief medical officer of Merck, Inc., objects that human challenge studies should only be contemplated when some lifesaving treatment, such as an antiviral medicine, is available for a candidate who gets sick. There is no such cure for COVID-19.

Then there is the problem of the unknown. Vaccines must pass muster with libertarians, descended from figures such as the enlightenment philosopher John Locke and the founding fathers of the US, who build morality around individual freedom. To counter libertarian objections, researchers must obtain “informed consent.”

Rosenblatt argues that when it comes to COVID-19, “It’s pretty hard to have informed consent when we barely know anything about this yet.” There are fears that the virus can cause lasting damage even in twentysomethings, for example, but little clear evidence. Can volunteers really consent to expose themselves to such poorly understood risks?

Finally, there is the appalling possibility of a volunteer dying. In 1999, this happened to Jesse Gelsinger, a healthy 18-year-old with a rare metabolic genetic disorder who volunteered for a conventional safety trial (not a challenge trial) of a virus-based gene therapy. His death was both a personal tragedy and a scientific disaster that “set the field of gene therapy back by at least two decades,” Rosenblatt said. “That hiatus deprived a generation of patients with genetic disorders of treatments.”

Morrison, of 1 Day Sooner, defends the right to volunteer for testing. Estimates at present are that the risk of death from COVID-19 for people in their 20s with no pre-existing conditions is under one in 10,000 — less than the risk of dying in childbirth while soldiers (whether volunteer or conscripted) face a far higher chance of dying on the battlefield.

HOW TO PAY FOR IT?

“A vaccine is meaningless if people are unable to afford it,” said John Young, the chief management officer of Pfizer, Inc. Nobody asserts that drug companies should be able to charge whatever the market can bear for a COVID-19 vaccine.

But private companies like Pfizer have a responsibility to shareholders. Moreover, anyone who develops a successful coronavirus vaccine will have performed an immense service to humanity and will deserve to be rewarded. And so Pfizer defends its right to make a profit.

Pfizer has a $2-billion deal with the US government to supply as many as 600 million doses of the vaccine it is developing. Many of its competitors are in collaborations with public universities, or receive state funding. That raises an intensely ideological issue: Should a private company be free to set prices for a public good developed with government aid?

“We have to make a profit out of the first product,” Moderna Chief Executive Stephane Bancel told Yahoo Finance. “We have invested $2 billion of our shareholder capital since we started the company. We need to get a return.” But Moderna has also received some $955 million in government funding to finance its big test. According to the Financial Times, Moderna is planning to price its vaccine at $25-$30 per dose, significantly above the $19.50 at which Pfizer is selling each of 100 million doses to the US.

Meanwhile, AstraZeneca PLC says it will sell the vaccine it is developing with Oxford to European governments at no profit, while Johnson & Johnson says it will sell its vaccine at a “not-for-profit price” for emergency use.

The issue is already very political. Five pharma industry leaders have had to testify on their pricing plans before a committee of the US House of Representatives, and Democratic-sponsored bills are in Congress to stop price gouging. They have some Republican support.

Representative Lloyd Doggett, a Texas Democrat who is sponsoring one such bill, told Politico that “a drug company’s claim that it’s providing a vaccine at cost should be viewed with the same skepticism as that by a used car salesperson.”

Once governments have bought the vaccine, should they require patients to pay for their own shots? Most people with money would happily pay much more than $30 to free themselves from the coronavirus. But in the many developed countries with nationalized health systems, the question doesn’t arise: taxpayers pay, and the vaccine is free for patients.

The US, however, has a political issue on its hands. Senator Patty Murray, a Washington Democrat, now backs a bill to ensure that every American has a right to a free vaccine. Meanwhile, the deal with Pfizer will result in free immunizations. Having established the principle of taxpayer-paid vaccines, it could be hard to retreat.

These are issues decided within countries. When it comes to international cooperation, poorer countries complain about “vaccine nationalism.” In the UK, Prime Minister Boris Johnson pulled out of the EU’s so-called Inclusive Vaccines Alliance in a move attacked for playing to his Brexit-friendly political base.

Wealthy countries have little incentive to collaborate with poor ones. Costa Rica led an effort with the World Health Organization to set up a new “COVID-19 Technology Access Pool” that would share research and then coordinate production — and also share the vaccine once it was ready.

But the list of countries that responded is telling. The US, China, Canada, and Japan are all absent, while the only European countries to sign up have been Belgium, Luxembourg, the Netherlands, and Norway. A group of much smaller developing nations has been left to build a collaboration — even though the virus knows no boundaries, and it is in all countries’ interest to stamp it out everywhere.

Meanwhile, rich countries are prospectively buying up vaccines before they have even been cleared for use. The US-Pfizer vaccine deal, and a similar deal with Glaxo PLC and Sanofi AG, uses American buying power to avoid excessive prices. Britain has done four separate deals with providers for 250 million doses.

What about the poorer countries who may have to pay more for the vaccine? For now, attempts at “vaccine justice” have been left to philanthropies such as the Gates Foundation’s Vaccine Network.

HOW TO RATION IT?

The pharmaceutical industry cannot produce enough vaccines for the entire global population of almost 8 billion all at once. Therefore, rationing is inevitable. Some people will have to wait. Who gets to make these decisions, and by what criteria?

Within the US, various medical bodies and government agencies claim authority to draw up the guidelines. No one seems empowered to adjudicate.

“The principle is to protect those most likely to be harmed,” said Caplan of NYU Langone. That leads to one point of clarity: Medical workers go first. They’re obviously at risk, and have a duty to put themselves in harm’s way.

But after this, following his criterion leads to prioritizing some of the least privileged in society — not because they are underprivileged and deserve help, but because they are most at risk.

Statistically, prisoners follow doctors and nurses on the list of people most likely to be harmed. As prisons are COVID-19 incubators, Caplan suggests that vaccinating inmates would limit the disease’s spread.

Within the US, Native-American communities are grievously affected, and therefore have a case for priority. The same is true of some other ethnic minorities, largely because they tend to live in crowded communities, and because higher rates of poverty make them more likely to suffer the underlying conditions that make COVID-19 more deadly.

People are also more at risk if they cannot work from home. In an e-mail, Anthony Skelton, a philosophy professor at the University of Western Ontario and Lisa Forsberg of the Oxford Uehiro