“When will we be rid of COVID-19?” isn’t a tough question to answer. A vaccine is one way to achieve herd immunity, the point at which the virus is statistically doomed, and there are over 150 candidates currently being tested for the spot. But it’s not enough to just be safe and effective; a successful vaccine must also be distributed to large swaths of the world’s population to provide large-scale immunity.
A group of self-described citizen scientists have thrown their hats into the vaccine race with a candidate that has not been formally evaluated for safety, efficacy, or scalability. MIT Technology Review first reported that this group, called the Rapid Deployment Vaccine Collaborative (Radvac), has ties to Harvard Medical School researchers, and over 20 members of it have self-administered the intranasal vaccine.
The collaborative recently released a white paper detailing why and how they produced their vaccine for it to serve as a “foundational document of knowledge” for other researchers, according to Radvac co-founder Alex Hoekstra. In the paper, the authors list the equipment and raw materials used to make the vaccine and write that they are all commercially available.
The DIY vaccine has become a flashpoint for the open source movement, which seeks to remove barriers to accessing and participating in research. While some support Radvac’s intent to share science through alternative pipelines, many believe that the group has gone too far.
Interest in biohacking organizations that produce and share cheap, DIY alternatives to medications has risen as a result of a capitalist system that has made life saving prescription drugs cost-prohibitive. But while producing DIY insulin or HIV drugs has a clear benefit to the individual, a vaccine is only effective when it’s taken by an entire population, not just a handful of citizen scientists.
“It’s worthless,” said Jeffrey Kahn, the director of the Johns Hopkins Berman Institute of Bioethics. “This will have zero benefit in terms of an eventually approved vaccine, because the information yielded by this is collected in a way that is inconsistent with policy, practice, and ethics.”
Radvac’s website states that they released information about their vaccine “as a necessary act of compassion,” but Kahn expressed skepticism. Even if the vaccine were effective, he said, giving it to a couple dozen people does not make a difference on the population level.
At the same time, the Radvac vaccine represents a long-needed reassessment of profit-dominated drug pipelines, said Roxana Bonnell, a senior program advisor with the Open Society Public Health Program.
“We as [the Open Society Foundations] are supporting and encouraging discussions with scientists, researchers, activists, and policy-makers, thinking about how power might be transferred outside of the traditional pharmaceutical industry,” she said.
The Radvac vaccine is peptide-based, meaning it contains short chains of viral amino acids that can be produced synthetically or taken from bacteria that have been engineered to make the specific chains. The vaccine also contains an adjuvant, which is meant to provoke a person’s immune response so that it will catalogue the peptides and learn how to destroy them.
Hoekstra said in an interview that preliminary results have been “promising,” but declined to elaborate on the tests used and results analyzed.
One drawback of the vaccine is that even if it did lead a person’s immune fighter cells to recognize the virus, there wouldn’t necessarily be a good way to measure that immunity. Because the vaccine is delivered nasally and not through a shot, blood tests like the ones currently used to quantify COVID-19 antibodies wouldn’t directly measure mucosal immunity.
Another issue, according to Kahn, is that the Radvac vaccine isn’t scalable and doesn’t meaningfully contribute to population-level health.
“Vaccination is about public health, it's not about two or three people vaccinating themselves,” he said. “We need to have whole parts of the public vaccinated in order to confer immunity such that infectious disease stops circulating, and DIY vaccines are never going to provide that.”
Calls for open source science that anyone can participate in have increased during the pandemic, with advocates pointing to the need for equitable relief and arguing that traditional pipelines for research and discovery aren’t working fast enough.
“The time pressures are incredible. Watching the daily counter of who has died and who has been infected in this country is horrifying, so I understand the urge [behind what Radvac is doing],” said Gui Cavalcanti, the founder of Open Source Medical Supplies, a grassroots network that has shipped 15 million units of medical supplies around the globe since March. Still, he said that an unregulated vaccine like Radvac’s has the potential to cause “systemic harm” if people become ill after using the white paper to make and self-administer it.
Experts interviewed agreed that some regulation for a medical product like a vaccine is necessary, but they differed on how much and by whom such a product should be regulated.
“I don't think we should be in a universe without regulation,” Bonnell said; however, she added that the current regulatory environment allows for conflicts of interest to persist and influence policy-making.
Kahn stressed that regulatory agencies exist to protect people, and that the FDA was created to crack down on snake-oil salesmen and charlatans. Self-experimentation has been around as long as science itself, he said, and it’s irresponsible for Radvac to post online instructions for a DIY vaccine.
Hoekstra said that he believes other individuals will use the white paper to make the vaccine themselves; however, he said that Radvac’s purpose is not to flaunt the FDA, but rather to empower researchers to take on the mission of vaccine development.
Open Source Medical Supplies is filled with makers who create supplies like cloth masks that aren’t FDA-approved, according to Cavalcanti. Still, he said that he envisions a movement that has its own regulatory pathways that run parallel to traditional ones.
“One of the best things that we can do in the open-source movement is try to build in as much feedback and self-checking as possible,” he said. “Creating these structures that have a bias toward action is something we should be striving for.”