The ingredients arrive by mail, to be prepared by recipients in their homes or labs. No, this isn't a DIY meal kit — it's an unproven COVID-19 vaccine distributed by a group called the Rapid Deployment Vaccine Collaborative, or RADVAC, and no one knows if it actually works, MIT Technology Review reported.
The collaborative, composed of more than 20 scientists, technologists and "science enthusiasts," some affiliated with Harvard University and MIT, did not seek authorization from the U.S. Food and Drug Administration (FDA) before designing their vaccine, or before spraying it up their own noses. Nor did the group seek approval from any ethics board before launching the project and volunteering as their own test subjects in what could potentially be seen as an unofficial clinical trial, according to MIT Technology Review. They have also distributed materials for the vaccines to dozens in their social circles.
The FDA did not immediately respond to questions from MIT Technology Review as to whether the initiative can be considered legal. However, geneticist Preston Estep, who founded RADVAC and serves as its chief scientist, said that the FDA does not have jurisdiction over the project because participants mix and administer the vaccine themselves, without paying the collaborative any fees in exchange. It remains to be seen whether the FDA might step in to regulate the project, particularly as more people learn about, and take, the experimental vaccine.
"We don't suggest people change their behavior if they are wearing masks, but [the vaccine] does provide potentially multiple layers of protection," Estep told MIT Technology Review. However, RADVAC does not yet have evidence that the vaccine prompts an adequate immune response to be protective at all. The group has begun conducting studies to answer that question, some of which are being conducted in the Harvard lab of geneticist George Church, who has already taken two doses of the vaccine. (Estep is a former graduate student and current collaborator in Church's lab.)
"I think we are at much bigger risk from COVID [than from the experimental vaccine], considering how many ways you can get it, and how highly variable the consequences are," Church told MIT Technology Review. Church added that, while he believes the vaccine is safe (in the absence of data proving that's the case), he thinks the "bigger risk is that it is ineffective." (Church is also head of Harvard's Woolly Mammoth Revival team, whose aim is to insert genes from the extinct mammoth into DNA of Asian elephants.)
But regardless of whether or not the vaccine grants protection against the coronavirus, vaccines always carry some risk of side effects. The more than 30 candidate COVID-19 vaccines being tested in sanctioned clinical trials must undergo several rounds of efficacy and safety tests to be approved, Live Science previously reported. In early trials, vaccine developers watch for acute side effects that occur shortly after vaccine administration, which may include swelling, redness and soreness at the administration site, or potentially fever. In advanced clinical trials, they can monitor for side effects that may emerge when a vaccinated person becomes exposed to the virus in a real-world scenario.
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One side effect that could occur upon exposure is known as antibody dependent enhancement (ADE); this rare phenomenon paradoxically leaves the body more vulnerable to severe infection after vaccination, and was previously observed in animal studies of vaccines for coronaviruses related to SARS-CoV-2, the virus that causes COVID-19, Live Science previously reported.
Self-experimenting with the RADVAC vaccine is "not the best idea — especially in this case, you could make things worse" by triggering ADE, George Siber, the former head of vaccines at the pharmaceutical company Wyeth, told MIT Technology Review. "You really need to know what you are doing here."
Siber added that, given the vaccine's ingredients and its route of administration through the nose, he's not sure that the vaccine would be potent enough to be protective, even if it is safe.
RADVAC published a white paper detailing the recipe for the vaccine in July, with a disclaimer that states that anyone using the information must be a consenting adult, based in the U.S., who agrees to "take full responsibility" for their use of the information, vaccine and materials required for production and administration. In addition, anyone accessing the site must first "acknowledge and agree that any use of that information to develop and self-administer a substance is an act of self-experimentation," the legality of which may differ depending on where you live.
Below the disclaimers in the paper, the group describes the formulation of the vaccine, which contains short protein fragments, called peptides, found on the coronavirus. These peptides cannot cause COVID-19 on their own, but should in theory be recognized by the immune system and prompt the construction of antibodies that can target and deactivate the virus. That said, Estep called Siber about the vaccine earlier this year and Siber told him that short peptides don't consistently prompt a strong immune response, according to MIT Technology Review.
In addition to peptides, the RADVAC vaccine contains chitosan, a substance found in the shells of crustaceans like shrimp, according to the white paper. The chitosan is intended to coat the peptides and ease their delivery through mucosal tissue in the nose, MIT Technology Review reported. The RADVAC developers chose to deliver their vaccine in a nasal spray, rather than through an injection, in an attempt to trigger a strong, localized immune response in the nose, where COVID-19 infection often takes hold.
Mucosal tissues, like that of the nose, have their own specialized fleet of immune cells that help guard the somewhat-permeable tissues against debris and pathogens, Live Science previously reported. Ideally, an effective COVID-19 vaccine would trigger both this localized immune response and a systemic immune response throughout the body. Some experts share the view of RADVAC, in that they think COVID-19 vaccines delivered through the nose would be more protective than injectable ones, The New York Times reported. However, Siber told MIT Technology Review that he's not aware of any existing vaccines that are both based on peptides and delivered through the nose; studies would be needed to confirm that such vaccines could reliably trigger a robust immune response.
While the underlying theory may prove true, the efficacy of individual vaccines can only be shown through rigorous analysis of the body's immune response. RADVAC has not completed such studies.
Having presented no evidence that the vaccine provides protection against COVID-19, or that it's safe to administer, the researchers have already distributed materials for the vaccine to others in their social circles.
"We have delivered material to 70 people," Estep told MIT Technology Review. "They have to mix it themselves, but we haven't had a full reporting on how many have taken it."
Originally published on Live Science.