Covid-19 vaccine confronts humanity with tough moral tests

Vexing issues range from the design of tests to cost burdens to who should get the vaccine first

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 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 towards creating a vaccine that would offer the best chance to end the pandemic.

But the moral dilemmas provoked by the development and distribution of a vaccine will drive ever deeper debates.

The newly published Ethics And 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.

HOW TO DEVELOP IT?

The United States government says the Covid-19 vaccine will be developed "at warp speed".

But vaccines take years to develop for good reason. A failed Covid-19 vaccine not only fails to confer any benefits - it 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 Dr Arthur Caplan, the head of bioethics at the New York University Langone hospital system, 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 biotechnology firm Moderna in Boston and at Oxford University in Britain, who are working on the two most promising attempts to find a vaccine.

How much risk of harming humans can they justifiably take?

 REUTERS
The biomedical industry and research facilities around the world are progressing towards creating a vaccine, but the moral dilemmas provoked by its development and distribution will drive deeper debates, says the writer. PHOTO: REUTERS

The best way to accelerate the process could fall foul of the long-established obligations of medical ethics, from the Hippocratic Oath to "do no harm".

That pledge aligns with the powerful school of rights-based philosophy identified with the 18th-century German philosopher Immanuel Kant.

Virtuous ends do not justify unethical means, Kantians argue.

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 neutralise. 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, 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 last month.

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.

Moderna's chief medical officer Tal Zaks 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.

Further, doctors are morally obliged to tell volunteers how to avoid getting infected.

 
 

They cannot tell them to go mask-less, or to seek out crowded spaces, even though from a narrowly scientific point of view this would improve their test results.

Dr Michael Rosenblatt, a Harvard Medical School professor, objects that human challenge studies should be contemplated only when some life-saving treatment, such as an anti-viral 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 who build morality around individual freedom.

To counter libertarian objections, researchers must obtain "informed consent". Dr 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".

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", Dr Rosenblatt said.

"That hiatus deprived a generation of patients with genetic disorders of treatments."

Mr Josh Morrison, who heads advocacy group 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.

HOW TO PAY FOR IT?

Chief management officer of pharmaceutical giant Pfizer John Young said: "A vaccine is meaningless if people are unable to afford it." 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 US$2 billion (S$2.75 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?

Moderna chief executive Stephane Bancel told Yahoo Finance: "We have to make a profit out of the first product."

He added: "We have invested US$2 billion of our shareholder capital since we started the company. We need to get a return."

But Moderna has also received some US$955 million in government funding to finance its big test.

 
 

According to the Financial Times, Moderna is planning to price its vaccine at US$25 to US$30 per dose, higher than the US$19.50 at which Pfizer is selling each of its 100 million doses to the US.

British drug-maker AstraZeneca 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.

Democratic-sponsored Bills are in Congress to stop price gouging.

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 US$30 to free themselves from the coronavirus. In the many developed countries with nationalised health systems, the question doesn't arise: Taxpayers pay, and the vaccine is free for patients. These are issues decided within countries. When it comes to international cooperation, poorer countries complain about "vaccine nationalism". Wealthy countries have little incentive to collaborate with poor ones.

Costa Rica led an effort with the World Health Organisation 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.

Meanwhile, rich countries are prospectively buying up vaccines before they have even been cleared for use. 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 vaccine for the entire global population of almost eight billion all at once.

Therefore, rationing is inevitable.

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. Dr Caplan says: "The principle is to protect those most likely to be harmed."

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 prioritising some of the least privileged in society.

 
 

Statistically, prisoners follow doctors and nurses on the list of people most likely to be harmed.

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.

People are also more at risk if they cannot work from home.

University of Western Ontario philosophy professor Anthony Skelton makes a case for sending those in work-at-home professions to the back of the line.

All of these proposals spring from prioritising people according to risk, but might in practice look like the kind of redistributionist social justice crusading that provokes controversy, particularly in the US.

Rationing could also be affected by where the vaccine was tested. In the case of Aids (acquired immune deficiency syndrome), experimental treatments were assessed in Africa, where testing was cheaper, but the treatments then went to developed countries.

Severely affected African countries had to pay prohibitive prices.

Africa could become a Covid-19 test site if regulators do not permit human challenge tests elsewhere.

If large-scale testing does happen there, justice will demand that early supplies of the vaccine are made available to Africans, even at the expense of people in the researchers' home countries.

HOW TO ROLL IT OUT?

Vaccinations work best when everyone receives them, since germs that can't infect people tend to wither away. But all vaccines come with risks. That creates a free-rider problem.

The best option from a self-interested point of view is that everybody else has the shot (eliminating your personal risk of catching Covid-19) - but that you don't (avoiding any personal risk of side effects). The public health case for compulsion is strong.

But libertarians have a problem with forcing a potentially harmful vaccine on someone without the "informed consent" that's hard to procure in societies sceptical of experts and low on social trust.

How can the vaccine reach a critical mass without compulsion?

 

Dr Caplan suggests leaving compulsion to private entities. An employer might demand vaccination as a condition of reporting for work. A vaccine might be dangled as a golden ticket to return to theatres, cinemas, night clubs or sports events. Governments or foundations could even pay people to receive a shot.

By this thinking, those who assert their right not to be vaccinated would be free to work from home and home-school. They would be voluntarily narrowing their own freedom of movement and assembly. Yet societies would pay a price. The virus has divided humans in countless ways already. If many citizens opt to stay unvaccinated, the virus and the messy ethics of compelling vaccination will have helped to create another permanent division.

BLOOMBERG.

• John Authers is a senior editor for markets. Before Bloomberg, he spent 29 years with the Financial Times, where he was head of the Lex Column.

 
A version of this article appeared in the print edition of The Straits Times on August 04, 2020, with the headline 'Covid-19 vaccine confronts humanity with tough moral tests'. Print Edition | Subscribe