Truly Expediating Vaccines

Two COVID-19 vaccines are in large-scale trials in the United States. Federal bureaucrats have thus far rejected human challenge trials (HCT), which would intentionally expose volunteers to the virus and speed testing. HCT should be part of our vaccine approval process.

Vaccine testing employs randomized control trials with subjects assigned to either a trial group receiving the vaccine or a control group receiving a placebo. Neither subjects nor trial personnel should know who receives the vaccine. Randomized control trials help ensure that the treatment causes any differences in health outcomes.

Traditional trials, however, involve an enormous unknown, whether a participant encounters the virus. Even a super-effective vaccine will not appear effective if control group subjects do not encounter the virus and get sick.

Vaccine trials consequently employ large samples; the current trials each involve 30,000 subjects. Traditional trials also cannot control when exposure occurs, lengthening vaccine trials. The SARS-CoV-2 virus is circulating widely enough to possibly produce results within three months but Britain may have to use HCT for the Oxford University candidate vaccine.

Deliberately exposing subjects to a deadly virus is problematic since control group subjects receive only a placebo. For COVID-19, restricting HCT to young adults should limit risk. Participants in an HCT would be closely monitored and provided the best possible medical care if needed.

Medical researchers use informed consent as an ethical guide. Whether informed consent suffices to make HCT voluntary resembles questions economics deals with regarding “voluntary” market transactions. Many jobs are inherently dangerous, like mining and commercial fishing, and were much more deadly 100 or 150 years ago. Should workplace deaths be regarded as corporate murder?

Economists focus on whether employers try to hide a risk and whether workers can easily quit if they decide the danger is too great. Dangerous jobs pay higher wages, suggesting that workers understand and accept the risk.

Freedom presumes that adults are competent and entitled to make decisions for themselves, including decisions that might shorten their lives. I believe that the thousands of volunteers for HCT registered with advocacy group 1DaySooner understand the risks involved.

HCT would enormously benefit vaccine testing. Effectiveness trials could be completed much faster, perhaps in as little as six weeks. Sample sizes could be much smaller since all participants get exposed to the virus, and multiple candidate vaccines could be tested against one control group. Researchers could also learn about the illness, like whether some people have natural or transferred immunity to COVID-19 or if asymptomatic patients can transmit the virus to others.

Every day we shorten the testing process will save lives. Since April 1, at least 209 Americans have died of COVID-19 each day, with an average of over 1,100. At least 17,000 deaths have occurred over every thirty day span since then. Delay is deadly with a pandemic.

Yet a commentary from the National Institutes of Health stated that HCT would be unacceptable without a “rescue therapy” (or cure) for subjects who became ill. They stated, “A single death or severe illness in an otherwise healthy volunteer would be unconscionable and would halt progress.”

This is nonsense. If we had a cure, we would not need a vaccine to save lives. Volunteers not infected as part of HCT could still get COVID-19 and possibly die. Traditional trials need control group subjects to get sick to demonstrate a vaccine’s effectiveness.

Yes, a Federal bureaucrat would have to order HCT subjects be infected. Taking versus refraining from taking an action sometimes is ethically significant: a bodyguard who fails to take a bullet intended for the person he is guarding is not guilty of murder. But vaccines cannot be marketed in the U.S. without FDA approval. Our regulatory regime denies Americans the freedom to try a vaccine, so bureaucratic inaction also produces death.

Hopefully one of the candidate vaccines in trials will prove highly effective. But new viruses will produce future pandemics. The regulation of medicines is for our benefit, not the comfort of bureaucrats. We should insist on the use of human challenge trials for vaccines.