There are only two ways human action can get the SARS-CoV-2 virus permanently behind us and return to normal life: we either develop a knock-out therapy that kills the virus dead in people who have contracted it, like powerful antibiotics do with bacterial infections, or we need to develop herd immunity. Without one of those, we are left hoping that the virus simply burns itself out and disappears. That would be foolish. But a knockout drug—a cure—is highly unlikely. There is no such drug for the seasonal flu or for the rhinoviruses that cause the common cold. So while effective therapies should be a part of the strategy to combat the ill effects of this virus, and sensible precautions like masks can prevent its spread, the only way to permanently defeat it is through herd immunity.
Doctors and public health officials all know this. So do politicians. Governor Gavin Newsom (D-Calif.) said during a press conference describing his plan for reopening California: “Normal it will not be. At least until we have herd immunity and a vaccine.”
Most people think, having “flattened the curve” and avoided the dire predictions of millions dead made just weeks ago, that we’ve defeated the virus. We haven’t. What we did was slow the infection rate and that’s good; but the virus is still circulating and countries with much better testing and tracing systems like South Korea and Singapore have experienced further outbreaks after reopening which, in turn, have led to more lockdowns. We want to avoid both of those things. Escaping that unhappy fate means getting to herd immunity quickly.
Herd immunity is achieved when roughly 70 percent of the population is immune to the virus either because of a natural genetic immunity or because they have developed antibodies against the virus as the result of prior exposure. When this happens there are not enough available hosts for the virus to spread and it slowly peters out and becomes, from a public health standpoint, more of a nuisance than a threat, before fading away.
Vaccines are the way we create this immunity without infection, thus, developing an effective vaccine is the safest path to herd immunity. That’s what we did with polio, measles, mumps, smallpox, and a number of other dangerous diseases that once vexed mankind. A vaccine eliminates the danger of the virus and the political, cultural, and economic miasma that comes with it.
It is the fear resulting from our lack of herd immunity that is leading and will continue to lead to bad decisions.
Toward Rapid Vaccine Development
The best way to solve this problem isn’t penning people up in their homes. It’s not even a massively expanded sentinel system built around quick, reliable, ubiquitous testing. That would be an improvement over the status quo and such improvements in testing should be pursued, but it’s not enough.
The belief that testing can be a fix is just as much a sign of institutional failure as the quarantines and lockdowns for which more testing would serve as a predicate. The best way forward is an aggressive scientific effort that solves the problem rather than a turbo-charged regime of testing and quarantining, which is basically a strategy of delay and on-the-fly mitigation. That isn’t greatness.
That’s why we need an equivalent of the Manhattan Project to quickly develop, test, manufacture, and distribute a vaccine for COVID-19. No expense should be spared and the best and brightest should be recruited to the effort as a matter of national urgency. There is no more pressing concern. It also shouldn’t take them too long. Their goal should be complete success by autumn.
Does that sound too aggressive? It isn’t. We’ve done it before.
On April 17, 1957—almost exactly 63 years ago—Dr. Maurice Hilleman, the head of respiratory diseases at Walter Reed Army Institute of Research, identified a dangerous viral threat that had originated in the Guizhou Province of China. He predicted that it would infect a large number of Americans and kill hundreds of thousands if a vaccine were not developed immediately. So he went to work.
He was right in his prediction, and because of him, a vaccine was ready in September. Nonetheless, that year the United States suffered the largest flu pandemic since 1918-19, with 116,000 succumbing to the virus. Many more would have died but for Hilleman’s work.
It is important to remember, however, that Hilleman was only able to do it by breaking the rules. One history says, “Hilleman bypassed regulatory agencies in his efforts to push the vaccine forward because he worried those agencies would slow the process down.” The release of that vaccine effectively ended the pandemic. Hilleman was a giant in his field, developing more than 40 vaccines and winning the National Medal of Science in 1988.
There are some differences between then and now: the 1957 virus was related to a prior virus that already had been studied, so researchers had some experience with its relatives. Now we are facing a novel coronavirus. But today we have much more advanced means of analyzing this and any other novel virus, and we can do it much more quickly than could have been done in 1957. New technology more than offsets the advantage they had in familiarity with a similar virus.
But there’s a catch. We’re not the same country we were in 1957. We’re buried under many more layers of administrators, regulators, and rulemakers. We’re also much more risk-averse. When Dr. Hilleman went to work on his vaccine, he simply acted, like great scientists have done in the past. He didn’t waste time filling out the proper forms, he just did it. That’s almost inconceivable today. It would likely be career ending, if not literally criminal.
The safeguards that surround vaccine development work relatively well under normal circumstances when time is not critical. But that’s not our situation. Every day counts.
No Good Strategies Now
And what people don’t understand is that right now, there is no good strategy in place to permanently end the threat of the virus. There are short-term tactical plans, hastily thrown together, with the assumption that a vaccine will work its way through the usual process in a year or two. The impression left with most people is that by pursuing an aggressive policy of lockdowns and shelter-in-place orders to slow the spread of the virus, we will vanquish it and then return to life as normal. But we shouldn’t count on that. The cost is too high and the virus will still be circulating.
Policymakers hope that with a national regime of rapid testing, contact tracing, and isolation of infections, they can preclude future outbreaks of the type seen in New York City and northern New Jersey. But even now there isn’t enough testing capacity and test results take far too long. And government now is looking at tech giants like Google and Facebook to monitor their users’ vital signs, movements, and internet activity through their phones in order to track signs of infection. Tim Cook already infamously said that Apple’s policy on surveillance of its users is to go up to the creepy line but not over it. This goes well beyond that line. It is so invasive that it makes the Patriot Act look like it was written by civil libertarians.
If we do nothing, we are left with the scenario described by Neel Kashkari, president of the Minneapolis Fed, on “Face the Nation” on April 12th. He said that the Fed is monitoring foreign countries that have lifted their lockdowns and that every time, there are second and third wave outbreaks when they do so. As a result, he explained, Americans will have to learn to live with rolling lockdowns for the next 18-24 months, by which time he thought a vaccine would be ready.
That’s too long.
But it would only take that long if we do things according to the usual procedure. We can’t afford to do it that way. Doing it that way would be an utter failure of leadership.
So far Congress has spent over $2 trillion to blunt the economic effects of the lockdowns. They will surely spend much more. And in every one of those emergency bills, everyone knows there will be all kinds of grift inserted at the last moment to benefit some rent-seeking group or another. Already Democrats tried to add a laundry list of liberal priorities like additional funding for Planned Parenthood to the last bill. Add to this the trillions in quantitative easing so far committed by the Federal Reserve and you have a mind-boggling sum being spent as a result of our experiment in national quarantining.
Time To Step Up Human Challenge Trials
Compared to the sums already committed, spending what might amount to tens of billions to rush a vaccine is a small price to pay for getting our lives back. Without it, what happens? Will we have impromptu local and regional lockdowns this fall when the seasonal flu surges? What about the psychological hangover that leaves people cautious, even afraid, to go to a restaurant or ball game? How many trillions of spending in future emergency bills would it save us? What’s more, a vaccine would be a strategic victory for the United States. It would show that America can innovate and create solutions for ourselves and for the entire world.
It would also create a template for fast-tracking vaccines what undoubtedly will be necessary in the future. And we can reasonably assume that the teams working on the project will learn new things with other applications that as of yet are unforeseeable. As a bonus, I’d bet we would get some really good science out of it that could lead to positive unintended consequences.
How do we do it?
First, we keep it out of the hands of the public health bureaucracy. President Trump should appoint a czar to oversee this project and give him broad power to act as he sees fit without answering to any existing agency like the FDA, the CDC, or DHS. Computer modelling has already allowed pharmaceutical companies to develop a number of promising vaccine candidates, but trials take a long time to put together. That’s a delay we don’t need and can’t afford.
The czar should recruit teams of top scientists and technologists in both the public and private sector to the effort. The teams would work on parallel tracks, shielded from the usual regulatory burdens and whoever gets to the finish line first, wins. The czar’s job will be identifying and recruiting the right people to develop the vaccine, getting them the resources they need quickly, and then protecting them from the outside world so they can do their work. When a vaccine is ready for production, the manufacturer should be shielded from tort liability and the federal government should guarantee purchase of enough quantity to make mass production economic.
However, standard testing protocols for potential vaccines create a bottleneck and take time that we don’t have. But there’s a solution: human challenge trials.
These involve intentionally “challenging” humans with an infectious disease. This is potentially controversial and is not normally done. But these are not normal times and it can be done responsibly and ethically. Contemplating this possibility, Curtis Yarvin asked in a noteworthy essay describing a much broader program than I describe here, “Who are these humans?” Good question. He had an answer that sounds right: “Maybe they are altruistic volunteers. Maybe they are mercenaries, paid a million bucks each—cheap at the price. It is difficult to imagine much trouble recruiting either class.” I tend to think that when there is a need, there are people who will answer the call even when it means risking their own lives. There are brave, selfless people in the world who would step forward. And for the good it would do mankind, they should be richly rewarded.
This idea may be unorthodox, but respected scientists are also advocating for it. Nir Eyal, Marc Lipsitch, and Peter G. Smith argued for just this approach in a major article in the Journal of Infectious Diseases. They said, “Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly.” Lipsitch, an epidemiologist at Harvard has been one of the more interesting and innovative people in his field working on solutions to the virus.
Once developed we’d need to scale production and distribution quickly. In 1957, Merck was ready with millions of doses of vaccine in September for something that had only started in development a few months earlier. We can do this, what we need are the right people in charge and the obstacles out of the way. Balaji Srinivasan succinctly described what this would look like: “1) List all credible vaccine candidates 2) Recruit enough volunteers for challenge trials 3) Obtain sufficient funds, legal assistance, lab, hospital space for each trial 4) Execute all trials in parallel.”
For the best chance of success, we need the best innovators who have quickly scaled businesses and who aren’t wedded to the incrementalism either of Washington or corporate America. Find entrepreneurs with a background in science or technology who have scaled pioneering businesses in emerging fields. Elon Musk comes to mind. So does Palmer Luckey. Ask successful venture investors like Peter Thiel and Marc Andreessen for their recommendations. Both have a track record of backing energetic, talented people. Marc Lipsitch of Harvard should certainly be involved. What is essential is that it be done soon.
It’s a sign of institutional failure and a lack of cultural vitality that we resort to the most draconian, most primitive response to a virus. And instead of science, we get scientism—the ritualistic display of competence rather than truth. Let’s do real science and build something new and powerful. America has a lot of smart, innovative people. Let’s put them to work.