By Yong-Bee Lim, October 7, 2021
A US Air Force medical technician prepares a dose of the Moderna COVID-19 vaccine. Credit: Stuart Bright / US Air Force.
Experts predict that more pandemics are coming. Climate change will drive migrations and other ecological disruptions that put species into greater contact with one another. Continued human encroachment on nature will increase the risks that a pathogen will jump from animals to people.
For the next pandemic, instead of waiting a year for scientists, governments, and companies to produce and distribute life-saving vaccines, wouldn’t it be nice to whip something up … in your own kitchen?
Strange as the notion sounds, at the outset of the COVID-19 pandemic, a few independent and some professional scientists thought made-at-home vaccines might help overcome what they viewed as the seemingly slow and unequal distribution of coronavirus vaccines. Ranging from self-identified biohackers to members of a collaborative that included prominent experts, these researchers sought to develop home-brewed, do-it-yourself (DIY) vaccines.
Two of these DIY vaccines focused on developing immunity by inducing the body to recognize SARS-CoV-2’s unique spike, a protein structure on the surface of SARS-CoV-2 that allows it to adhere to, infiltrate, and infect host cells. By creating and introducing a person to these spike proteins via injection or nasal spray, the researchers theorized that the inoculated individual’s immune system could be induced to produce antibodies that would recognize SARS-CoV-2 and drastically reduce the virus’ ability to infect its host. If successful, this process could have been a first step toward creating not just a vaccine for COVID-19, but a proof of concept and potential path forward for responding faster and more equitably to future emerging disease threats.
But after more than a year-and-a-half since the first cases of COVID-19 were reported, the results, so far, are not promising. Non-traditional vaccine makers have yet to create a scientifically tested vaccine or provide a workable alternative to the existing public-private partnership model that has created the bulk of the world’s safe and effective COVID-19 vaccines.
Instead, because they have promoted a DIY product and process that is prone to human error and which has not been scientifically validated, the DIY vaccine makers have come to be seen by some critics as irresponsible. DIY vaccines, after all, offer people—particularly people in vaccine-starved parts of the world and parents with children ineligible for a government-approved vaccine—a potentially false and dangerous hope. Ironically, the DIY vaccine makers may also have set back the movement known as DIYbio, which stands for do-it-yourself biology, a cause they had hoped these vaccine efforts would shine a favorable light on.
Who are the DIY vaccine makers? To the uninitiated, the mention of amateur biological scientists who make up the DIYbio community can conjure up images of overconfident and reckless people injecting themselves with possibly dangerous substances that they do not fully understand. To experts in biosecurity and related fields, the concerns have historically run even deeper. In 2012, New York Times writer Carl Zimmer quoted renowned biosecurity experts and virologists to make the case that amateur scientists could create mutant flu viruses in garage labs.
Despite this bad press, the DIYbio movement has asserted the possibility of not only producing real innovations, but also creating a fairer distribution of scientific knowledge and technologies, particularly in the developing world. The movement attempts to do this through the four main activities it facilitates in virtual and physical spaces: exploration, education, empowerment, and entrepreneurship.
At least two groups have tried to make DIY vaccines against the virus that causes COVID-19. Although these groups were not associated with broader DIYbio community activities and platforms, some of the motivations were similar: a desire to do good and help others during a global crisis.
The Rapid Vaccine Deployment Collaborative (RaDVaC), composed largely of trained scientists and engineers from academia and industry, set out to develop the instructions for DIY vaccines that others could then develop and use via a creative commons license.
The group says initiatives like RaDVaC offer a path toward vaccine equity. “RaDVaC’s rapid-response vaccine platform is uniquely simple and modular, and easily modified for deployment in response to future outbreaks,” the group’s website says.
Preston Estep, who co-founded the group and has a doctorate in genetics from Harvard University, told me that he was motivated to ease the suffering associated with serious COVID-19 cases where “people were dying, slowly suffocating, all alone, trapped in a room.” He said that self-experimentation was not unprecedented and pointed to the work of Australian Neil Noakes, who handed his colleague Barry Marshall a solution filled with H. pylori to drink. Marshall went on to win the Nobel Prize for his work linking the bacteria to ulcers.
Many people associated with RaDVaC have impressive scientific pedigrees. Estep has been involved in biotech startups and was the director of gerontology for the Harvard Personal Genome Project, a large study that sequences and shares project-participant genome data to shed light on the relationship between genetic data and human traits. The group’s other co-founders also have significant backgrounds in research and analysis. Beyond the core founders, RaDVaC also includes notable scientists, including George Church, the famed Harvard Medical School genetics professor. These names and reputations help lend RaDVac legitimacy and prestige that other organizations in the DIYbio space lack.
To make its DIY vaccine, a core group at RadVaC looked at past papers on vaccines developed for other coronaviruses such as Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS). This research, combined with the goal of using readily-available materials and mail-order ingredients, led the group to produce a subunit vaccine candidate—a vaccine that, in this case, uses short bits of amino acid chains and protein subunits to mimic parts of the protein structure of SARS-CoV-2, in hopes of eliciting an immune response.
Since there is no infectious material associated with RaDVaC’s subunit vaccine prototype, which is delivered as a nasal spray, it cannot cause COVID-19. Given COVID-19’s targeting of the respiratory tract, RaDVaC product developers reasoned that a nasal spray might enhance mucosal immunity. As part of the DIY and open-source ethos this group adopted, it aims to make vaccines that others can replicate. “It’s actually easier than a lot of recipes in cookbooks,” Estep told Bloomberg News.
Estep told me that more than 100 people have self-experimented with the group’s vaccines, many with ties to the organization.
Another of the DIY vaccine efforts, Josiah Zayner’s Project McAfee (named after the anti-virus computer software), is rougher around the edges than RaDVaC. Zayner, a biophysics PhD, former NASA researcher, and now biohacker and bioentrepreneur, founded the project in May 2020. Among the DIYbio and biohacker communities, Zayner is a polarizing figure who has alienated some with risky and ostentatious experiments in the past. A long-time critic of the scientific establishment, Zayner operates a company called The ODIN, which sells materials DIYbio experimenters can use in their research. Beyond his penchant for self-experimentation, Zayner built a curriculum around his COVID-19 project to teach basic science and wetlab skills to amateurs.
To make his vaccine, Zayner used a study of rhesus macaques in a Harvard University paper. First, he ordered the DNA sequence that codes for the same coronavirus spike protein used in the paper, paying $1,600 to a DNA synthesis company. After a series of intermediate tests, the McAfee team suspended the DNA in solution and injected it into themselves during a YouTube livestream event on August 2020.
The Project McAfee team said that the team members who injected themselves all had antibodies that would react to the virus and that none of them appeared to have been harmed by their self-experimentation. But even Zayner agreed that his self-experimentation results were inconclusive.
Zayner, who said he was banned from YouTube after publishing his vaccine work, wrote in a blog post that his efforts were important nonetheless: “Even if it didn’t work, the fact that someone could have designed a vaccine in June 2020 for under $5k is fucking profound.”
Zayner did not respond to a request for comment for this piece.
DIY vaccines weren’t a speedy pandemic solution. One of RaDVaC’s goals is to reduce the amount of time it takes to produce vaccines during a pandemic. Though the first Pfizer shots were given less than a year after the World Health Organization declared COVID-19 a Public Health Emergency of International Concern, RaDVaC believes society could do better.
“When many thousands are dying every day, and with the scientific capability largely in place, rapid [vaccine deployment] must mean a few weeks, not several months or years,” the group’s website says.
But in the case of both Project McAfee and the RaDVaC collaborative, the research, development, and self-administration of prototype DIY vaccines happened around the same time Pfizer completed its Phase 1 trial in August 2020; the DIY vaccine projects were no swifter in reaching the goal of trying out a product on people than Pfizer’s vaccine candidate. Moreover, Pfizer and other vaccine makers gained robust data from Phase 1 trials that then allowed their products to undergo Phase 2 and Phase 3 trials, ultimately leading to regulators green-lighting their products.
Traditional science takes time, but the results—unlike those from self-experimentation—are reproducible. While the DIY groups have shared anecdotal data on their self-experimentation, they have released little to no good-quality data on any significant results on the safety or effectiveness of their products so far.
Why DIY vaccines aren’t a substitute for the current mode. Zayner told Bloomberg that he was “suspicious of my own data” and that large-scale trials would be necessary for vaccine work. Similarly, Estep and Church both acknowledged to me the anecdotal nature of their results. The work of RaDVaC could be considered “pre-research,” they said: preliminary observations that could help guide more formalized, scientific trials in the future.
Estep told me he is planning on pursuing trials of RaDVaC in animal models with a pharmaceutical company—a step in the right direction towards gaining data through animal-model clinical trials and one that replicates the more traditional model of pharmacological research and development.
But neither RaDVaC nor Project McAfee is a viable alternative to the large-scale efforts by governments and pharmaceutical companies to produce vaccines at this time.
In the face of the devastating effects of a disease like COVID-19, people might be tempted to try something like what RaDVaC or Project McAfee produced, particularly if the home-brew process is presented as “extremely simple” and “actually easier than a lot of recipes in cookbooks.” Whatever their motivation, it is highly likely that amateurs and untrained citizens will not have the proper biosafety and wetlab skills and knowledge necessary to safely or responsibly home-brew and inoculate themselves with either DIY vaccine.
The ultimate question is what lessons are to be learned from these DIY vaccine self-experimentation projects?
Neither of these projects accomplished its objectives. As problematic as they were in some ways, these DIY vaccine efforts did attempt to respond more quickly and equitably to this pandemic than the medical establishment could. In the future, clearly, faster pandemic response would be better pandemic response. Therefore, the world could use a new vision, one that updates existing institutions in ways that accelerate research, development, and evaluation of medical interventions—and distributes those interventions quickly around the world—without sacrificing standards for the safety and efficacy of vaccines and other therapeutics.
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Oh dear - the greatest safety, health risk is obviously posed by America's and the world's ever-proliferating, leak-prone, safety-violating, "self-policing" BSL2/3/4 biolabs. Why do so many otherwise highly intelligent people only focus on after-the-fact reactive solutions(masks and vaccines) whilst rarely if ever focusing on prevention and pre-emption specifically with regard to leak-prone, safety-violating biolabs ?
Ample, extensive warnings were issued between 2013-2019 by the GOA, USA Today, NYTimes, Homeland Security Newswire etc - but not effectively acted upon. See:
1) NYTimes:
"Pathogen Mishaps in Labs Rise As Regulators Stay Clear": https://www.nytimes.com/2014/07/20/science/pathogen-mishaps-rise-as-labs-proliferate-with-scant-regulation.html
2) "Inside America's Secretive Biolabs" https://www.usatoday.com/story/news/2015/05/28/biolabs-pathogens-location-incidents/26587505/
3) HomelandSecurityNewswire's:
http://www.homelandsecuritynewswire.com/dr20140722-the-number-of-labs-handling-deadly-germs-grows-and-so-do-calls-for-regulating-lab-safety
4)"GAO Accountability High-Containment" eg. at‘
https://www.gao.gov/pdf/product/652308
5) Nature magazine, January, 2020:
"US Officials Revisit Rules for Disclosing Risky Disease Experiments" at:
https://www.nature.com/articles/d41586-020-00210-5
Paul G