Vaccines, the Trolley Problem, and what comes next

If you took any philosophy courses in college (or watched The Good Place), you’re likely familiar with the trolley problem:

There’s a runaway trolley barreling down the tracks. Ahead, tied to the tracks, are five people, totally unable to move. The trolley is headed straight for them, full speed ahead. You’re safely off in the distance, standing in the trainyard holding a lever: if you pull the lever, you will divert the trolley to a different set of tracks, saving the five people. But on the different set of tracks, you see a single person tied to those tracks. With the trolley progressing at full speed, you have a moment to weigh two options:

1. Do nothing and allow the trolley to kill five people on the main track.
2. Pull the lever and divert the trolley onto the side track, saving five people but killing one.

The ethics of either choice in this theoretical exercise have been debated for decades. Today, the coronavirus pandemic has presented us with many real-world ethical questions — trolley dilemmas of their own kind, played out in real time with real human lives on the line: whether or not to lock down and create the burden of unemployment and social isolation in order to save lives, which jobs to classify as essential, and whether to grant emergency use authorizations vaccines that prevent COVID but may introduce unexpected risks.

Last week, America’s political and health policy leaders again found themselves holding the lever: the Food and Drug Administration and Centers for Disease Control paused the use of the Johnson and Johnson single-shot COVID vaccine amid concerns that it may have caused a rare, but dangerous blood-clotting disorder in a handful of individuals.

In many ways, the Johnson and Johnson decision is an inversion of the usual Trolley Dilemma: on the main track, we face the risk that the vaccine could cause clots in the brain, found in 6 women during use of the vaccine (one of whom died), and found in one man during the trials¹. On the side track, we have the risk of blood clots, death, and disease from COVID-19 itself. In this real-world trolley problem, the math suggests that pulling the lever leads to more deaths and more risky clots, not fewer. By intervening — in this case, pausing use of the vaccine is our flipping the switch) we don’t reduce overall harm, we increase it.

The consequences of this delay will be felt around the world.

In America, the Johnson and Johnson vaccine has been underused — fewer than 10% of total vaccinations have used the J&J shot. But the delay has irreparably harmed the reputation of comparable single-shot vaccines, including the Oxford/Astra-Zeneca vaccine. In a survey conducted after the pause announcement, YouGov found that more and more respondents now have negative impressions of those vaccines. Just 37% of respondents called the Johnson and Johnson vaccine safe, while 39% said it feels unsafe. That’s a problem that an extra week of FDA study simply won’t fix.

In less developed countries, this decision will have an adverse impact on our fight to reduce the likelihood of mutation and the global burden of disease. In those countries, the mRNA vaccines (from Pfizer and Moderna) are still too expensive for broad use, but the single-dose vaccines are well suited for mass rollout. By taking an action that will lead millions to incorrectly believe that the benefits of these vaccines aren’t worth the risks they present, we’ve undermined their potential to reduce the burden of disease for millions of people. We shouldn’t have pulled the lever.

Now, we have two major problems to solve: 1) American vaccination pace is plateauing. We’ve met President Biden’s goal of 200 million shots in the first 100 days of his administration, but we need to set ambitious new goals that will keep the vaccination effort on track and guide America toward eventual herd immunity. 2) The world faces a shortage of effective, affordable vaccines — the ones we have face a crisis of availability (Johnson & Johnson manufacturing has been greatly slowed due to errors) and trust.

So what can we do going forward? Here are 4 suggestions:

1. Restore use of the J&J vaccine immediately for men and any women not taking birth control. Give them to anyone who will take them.
2. Use the nursing home on-site vaccination model for high schools and junior high schools across America.
3. Keep up vaccine development and shipment. We need more affordable vaccines for the rest of the world, with a variety of delivery mechanisms.
4. Train the medical community on prescribing and navigating Covid-positive patients to the use of monoclonal antibodies.

Restore use of the Johnson and Johnson vaccine

First, we must restore the use of the Johnson and Johnson vaccine. The European Medicines Agency, which regulates vaccines in the European Union, has already done this. They made a clear statement that the vaccine is overwhelmingly safe and worth using, given it’s high reward and limited risks. In America, the reputation of J&J’s vaccine may be harmed, but there are still millions eager to take a single-dose vaccine. And we should give it to them — whoever wants it, whenever they want it. We should open availability to daily first-come-first-served at vaccination locations, while continuing to require appointments for the mRNA vaccines.

Use the nursing home model

The Pfizer vaccine is already approved for those aged 16 and older, and will soon be available to those aged 12 and older. The easiest way to make the vaccine available to children is by offering it at the place where they spend most of their time — school. In the earliest stages of the vaccination effort last December, the CDC worked with retail pharmacies like CVS and Walgreens to bring vaccines into nursing homes and vaccinate locally. We should do the same with schools. Even where remote learning is still common, students can come to school to get a Pfizer vaccine (and eventually Moderna, once it is approved for minors). We can do this safely, in communities everywhere, to reach more unvaccinated Americans.

While the reputation of the Johnson and Johnson vaccine has been harmed here, the Moderna and Pfizer vaccines are still overwhelmingly trusted. According to YouGov, a majority (58–59%) consider the two mRNA vaccines to be safe, with only one in five (18–19%) considering them unsafe. Parents are overwhelmingly comfortable with these vaccines, and want their children to be vaccinated as soon as possible. Local vaccination campaigns are most likely to succeed.

Keep up development

We should be honest: for a subset of America’s and the World’s population, trust in the Johnson and Johnson and Oxford/AstraZeneca vaccines is irreparably harmed. To defeat this pandemic, we’re going to need more proof of safety for those still on the fence, and more novel vaccine options for those unable to be swayed. Alex Tabbarok has spoken about the need for nasal (via inhaler) and oral vaccines, arguing that fear of needles is one significant force behind vaccine hesitancy. Spending more on research and development here, as well as in developing and approving new injectable vaccines, will pay dividends. Not only will this help the developing world, it will help vaccine-hesitant Americans (whether they fear needles or vaccine side effects), and anyone who eventually requires a vaccine booster. More delivery methods and more vaccines would be incredibly beneficial, and we should keep up the investment and clinical trial efforts to bring these to market, for this pandemic and for the inevitable next one.

Monoclonal antibodies

Finally, we should acknowledge an unfortunate reality: more people will refuse Covid vaccination, and more will get infected. While that’s frustrating and should eventually be avoidable, we will not get to herd immunity through vaccination alone. Infection will play a substantial role. But we have tools to blunt the impact of Covid infection — monoclonal antibody infusions from Eli Lilly and Regeneron are safe and effective. The challenge so far has been the difficulty in accessing them. Many physicians are unaware of the process to prescribe the monoclonal antibodies under emergency use authorization, and few know where to send patients to receive an infusion. One place where education funding can make an immediate impact is here: teach more physicians how to prescribe and how to work with local infusion centers, and make clear the benefit of early infusion of monoclonal antibodies in saving lives. While someone healthy and uninfected Americans may refuse a vaccination, far fewer will refuse a potentially life saving or life-improving treatment in the midst of Covid disease.

As the pace of vaccinations in America plateaus, we need to think differently. Those eager and eligible to be vaccinated are now fully vaccinated, waiting for a scheduled second dose, or scheduled for their first. As we surpass the President’s 200 million shot benchmark, we must pivot our focus to the populations that are neither eager nor eligible. Focusing on new approaches and new tools to treat these populations is our fastest and most efficient way out of this mess.

Thanks to friends and colleagues at Sesame for your helpful input.

¹ Some clarifications:

1. The blood clots seen during severe COVID infection are not identical to what has been found in those receiving the Johnson and Johnson vaccine. The reason for increased concern is that these are blood clots in the brain — cerebral venous sinus thrombosis (CVST), that are showing up along with thrombocytopenia (low platelet levels in the blood). A particularly rare and dangerous combination, because treating it the way one would normally treat a blood clot (with an anticoagulant drug like heparin) can actually make these worse. It’s unpredictable and very dangerous — of the 6 women identified after Emergency Use Authorization, one died and three others are hospitalized (one of them in intensive care). Thankfully, since the pause began there have been no additional patients identified.
2. The focus has been on women, and it certainly seems like women are more likely than men to develop this condition, but it’s not exclusive to women. One man developed it during initial Johnson and Johnson vaccine trials.