Scientists Take Do-It-Yourself, Untested COVID-19 Vaccine
A group of researchers, technologists or “science enthusiasts,” some with connections to Harvard University or MIT, have formed the Rapid Deployment Vaccine Collaborative (Radvac), created their own do-it-yourself COVID-19 vaccine and have begun testing it on themselves. The vaccine was developed by Preston Estep, a former graduate student of Harvard University geneticist George Church. Estep is the cofounder of Veritas Genetics. Church is one of the people who has taken the vaccine in two doses about a week apart.
“I think we are at much bigger risk from COVID considering how many ways you can get it, and how highly variable the consequences are,” Church told MIT Technology Review. “I think that people are highly underestimating this disease.”
Radvac was formed in March after Estep heard that most experts were predicting a vaccine would take 12 to 18 months. He sent an email to a group of his acquaintances, suggesting that a DIY project could move faster, and he thought there was “already sufficient information” published to make it happen.
Many of his volunteers worked on the Personal Genome Project (PGP), an open-science initiative that came out of Church’s laboratory in 2005. The PGP sequenced people’s DNA and posted the data online.
Estep said, “We established a core group, most of them [from] my go-to posse for citizen science, though we have never done anything quite like this.” The goal, he said, was to find “a simple formula that you could make with readily available materials. That narrowed things down to a small number of possibilities.”
For the vaccine design, they read research on vaccines against SARS and MERS, which are both caused by coronaviruses. Any ingredients were bought via mail order and the actual development work was conducted in borrowed laboratories. Estep claims the only equipment he needed was a pipette to transfer liquids and a magnetic stirring device.
Radvac posted a white paper describing the vaccine details online.
The vaccine is made up of fragments (peptides) of the virus. These types of vaccines are already used for hepatitis B and human papillomavirus. Novavax is using the same technology to develop a COVID-19 vaccine and has a $1.6 billion contract with the U.S. government’s Operation Warp Speed to do so.
The U.S. Food and Drug Administration (FDA) did not respond to MIT Technology Review’s request for information as to whether this entire project is legal. Estep argues that the agency does not have jurisdiction over the vaccine because its participants mix and administer the vaccine themselves and do not pay the group any fees. FDA attorneys may feel differently. As might attorneys representing anyone harmed by the vaccine.
At this time Radvac doesn’t identified any evidence that the vaccine stimulates an appropriate immune response or if it’s at all protective. They’re working on that, and some of them are being run at Church’s laboratory.
The vaccine is inhaled in the nose. Radvac mixed their peptides with chitosan, which is developed from shrimp and other crustacean shells that are crushed up and treated with an alkaline compound, such as sodium hydroxide. Chitosan coats the peptides with nanoparticles that allow the peptides to be absorbed into the mucous membrane.
Of the approximately 199 COVID-19 vaccines being developed around the world, only about five are using nasal delivery. One possibility is that it could create mucosal immunity, or immune cells being present in the nasal tissues. This theoretically could provide an earlier immune response against the SARS-CoV-2 virus compared to systemic vaccines (by injection) that require the virus to appear in the blood. But it is also far more difficult to test for the antibodies; instead of a simple blood test, mucosal antibody levels might require a tissue biopsy. But nasal delivery may require larger doses of the vaccine.
There is also no guarantee the vaccine will stimulate any kind of an immune response. George Siber, former head of vaccines at Wyeth, told Estep that the peptides they use often don’t create an immune response, and he also had doubts if nasal delivery would be potent enough to have an effect.
Siber also expressed concerns over a potentially dangerous side effect called immune enhancement, where the vaccine makes the actual disease worse. Siber noted, “It’s not the best idea—especially in this case, you could make things worse. You really need to know what you are doing here.”
Arthur Caplan, a bioethicist at New York University Langone Medical Center, upon reading the white paper, called Radvac “off-the-charts looney,” and told MIT Technology Review that he sees “no leeway” for self-experimentation and that there is a high “potential for harm” and “ill-founded enthusiasm.”
Church disagrees and argues that the vaccine’s simplicity probably means it’s safe, which would seem to be a gross oversimplification. “I think the bigger risk is that it is ineffective,” he said.
A Boston-area biotech executive who wants to remain anonymous but who was approached by Estep told MIT Technology Review, “It’s real, he’s a solid scientist, but I wouldn’t do what he is doing. He called me and said ‘Do you want it?’ and I said ‘no.’ ‘Do you want me to send you some?’ I said ‘No, I am not going to do anything with it, so don’t waste it on me.’ The less I know, the better.”