The danger of DIY vaccines.

The world needs to trust science if vaccines are to prove useful, particularly those being developed to combat coronavirus disease 2019 (COVID-19). That is what makes the recent appearance of highly visible “do-it-yourself” (DIY) vaccine research so morally troubling. It's an obstacle to securing this trust. As reported in last month's MIT Technology Review, at least 20 people are following the lead of geneticist and entrepreneur Preston Estep to take and promote a homebrew potential vaccine for COVID-19. They have formed a group, Rapid Deployment Vaccine Collaborative (RaDVaC), with the avowed mission of rapidly developing and sharing a vaccine recipe simple enough to be produced and administered by the public. On RaDVaC's website, the group describes itself as citizen scientists, although “many of us are trained scientists and engineers.” RaDVaC describes the formulation of its vaccine as containing peptides that prompt the user's body to generate antibodies to severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2, the virus that causes COVID-19). Furthermore, chitosan, a substance found in the shells of crustaceans, is added to coat the peptides and ease their delivery through mucosal tissue in the nose. The RaDVaC developers deliver their vaccine in a nasal spray in an attempt to trigger a strong, localized immune response in an area of the body where COVID-19 infection often takes hold. An untold number of them have taken one or more doses of this concoction, including the renowned Harvard geneticist George Church. So, what is wrong with a tiny group of high-profile scientists and their admirers developing a vaccine, administering it to themselves, and distributing the formulation to others who choose to try it? A great deal is wrong. The DIY RaDVaC initiative is far more likely to contribute to growing public mistrust of all vaccines than it is to provide a path forward to combating the pandemic. Those who are increasingly mistrustful of all the talk of “warp speed” in promising a COVID-19 vaccine are hardly going to be encouraged to change their minds by rogue scientists experimenting with no oversight at the fringes of what is ethically acceptable. The DIY effort has no animal or safety trials; no confirmation of safety by closely monitoring healthy volunteers; no dosage studies; no effort to review the proposed science or recruitment of volunteers by an outside, independent ethics review committee; no plan to record all users, to encourage diversity among users, or for systematic follow-up; and no plan to provide help or compensation to anyone harmed by their participation. Moreover, there have been no papers published or data released in peer-reviewed outlets about the vaccine. The research is rife with conflicts of interest in that those making the vaccine are recruiting friends to try it while promoting their actions in the media. They are not selling their vaccine but stand to benefit from attention in the media and any resulting philanthropic support. There are by most estimates around 200 COVID-19 vaccines in development around the world. Some three dozen are in human trials. A handful have progressed to full-fledged clinical trials. News accounts report that large-scale vaccination efforts without full human safety testing or ethical review are underway in Russia. Given the horrors inflicted on people around the world by the pandemic, it would be reasonable to expect that concerted efforts to find a vaccine would have huge popular support, but that is not the case. Large percentages of people polled in many nations say they will not use or are worried about the safety of a COVID-19 vaccine. Nearly half of all those polled in the United States and United Kingdom in recent months said they would refuse vaccination. COVID-19 vaccine skepticism has many sources, including doubts about the trustworthiness of safety claims made by government leaders whom many distrust; the perceived inability of government regulatory agencies to maintain independence from political pressure to quickly approve products; and impressions of financial conflicts of interest on the part of those making vaccines. Trust is the key ingredient in any effort to facilitate a vaccine solution to the current pandemic. Peer-reviewed science transparently assessed in carefully controlled trials by independent experts is the only way to cement that trust. DIY vaccinology is dangerous at a time when nonevidence–based claims of COVID-19 “cures” have done little but sow mistrust of science and public health.