President Trump recently announced “Operation Warp Speed,” a plan for a novel coronavirus vaccine by the end of 2020. I welcome the announcement because the greatest impediment to a vaccine now is the Food and Drug Administration’s (FDA) approval process. Speedy development of a vaccine is not without precedent.
The President’s comparison to the Manhattan Project, however, seems excessive. A vaccine is knowledge, which we may already possess. At least three candidate vaccines are in human safety testing, with perhaps thirty more in development. We hopefully have the recipe for an effective vaccine.
The FDA vaccine approval process starts with animal testing to evaluate safety and the production of antibodies followed by three phases of human testing. First is a very small sample to test safety; vaccines sometimes induce immune system reactions which damage organs. If judged safe, two rounds of randomized control trials ensue involving hundreds and then thousands of participants.
Only a safe and effective vaccine will benefit Americans. A vaccine will likely be part of returning life to normal. An ineffective vaccine may unleash another COVID outbreak and thousands of deaths.
Can this be accomplished quickly? Dr. Anthony Fauci has repeatedly stated that developing a vaccine will take 12 to 18 months; other experts suggest years. History shows otherwise, at least in one case. In 1957, a new strain of influenza, the Asian flu, was detected in Hong Kong in April. Dr. Maurice Hilleman, chief of respiratory diseases at Walter Reed Army Institute of Research, wanted a vaccine ready before it reached the U.S. When the flu arrived four months later, forty million Americans had been inoculated. The pandemic claimed 70,000 American lives, but the total likely would have been much higher without a vaccine.
Dr. Hilleman devised both an effective vaccine and a plan for manufacturing it. In devising his plan, according to History.com, Dr. Hilleman “bypassed regulatory agencies in his efforts to push the vaccine forward because he worried those agencies would slow the process down.”
How could we expedite the process today? I am not a medical researcher, but we could probably combine the two phases of effectiveness testing and test several candidates with a common control group. We could also employ human challenge testing and deliberately infect participants with the virus. We would administer participants a vaccine, give their immune systems time to develop antibodies, and then infect them with the coronavirus. Trials normally rely on participants running into a virus during their daily routines.
Human challenge testing offers several advantages. A trial would require fewer participants since all get exposed. The test concludes faster as exposure occurs immediately after the vaccine has had a chance to work. And researchers can control the exact exposure.
A significant ethical issue arises, as control group participants receive a placebo. Medical researchers would be intentionally infecting unprotected people with a deadly virus.
A paper in The Journal of Infectious Diseases, however, argues that human challenge testing could be ethical. We could include only young adults with no known risk factors, who face a low risk of death from COVID-19, provide them with the best healthcare available if needed, and seriously test informed consent.
A moral society is based on voluntary interaction. Consent distinguishes gifts from theft and democracy from dictatorship. I believe that informed consent justifies deliberate exposure to the coronavirus. History sadly provides examples of despicable, unethical medical experiments, like the Tuskegee Experiment. We will not be doing anything remotely similar here.
As an economist, I would further suggest compensating participants with fame if not money. Any participants who unfortunately die in the testing should know that we will commemorate their lives and sacrifice in the COVID pandemic museum.
Operation Warp Speed has let Americans know that we can guide the process of vaccine testing, not bureaucratic rules. Let’s now devise an expedited process to get an effective vaccine to Americans as soon as possible.