Ingredients arrive by mail, to be prepared by recipients at home or in laboratories. No, this is not a DIY food kit – it is an untested COVID-19 vaccine distributed by a group called the Rapid Collaborative Vaccine, or RADVAC, and no one knows if it actually works, The MIT Technology Review reported.
The collaborator, made up of more than 20 scientists, technologists and “science enthusiasts,” some affiliated with Harvard University and MIT, did not seek authorization from the Food and Drug Administration. -Drugs of the United States (FDA) before they designed their vaccine, or before spraying it on their own noses. Nor did the group seek approval from any ethics board prior to project launch and volunteering as their own test subjects in what could potentially be considered an unofficial clinical trial, according to the MIT Technology Review. They also distributed vaccine materials to dozens in their social circles.
The FDA did not immediately respond to questions from the MIT Technology Review as to whether the initiative could be considered legal. However, geneticist Preston Estep, who founded RADVAC and serves as its lead scientist, said the FDA has no jurisdiction over the project because participants mix and administer the vaccine themselves, without paying the no collaborative fees. It remains to be seen whether the FDA can act to regulate the project, particularly as more people learn about, and take, the experimental vaccine.
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“We don’t suggest that people change their behavior if they’re wearing masks, but [the vaccine] does not provide potentially multiple layers of protection, “Estep told the MIT Technology Review. However, RADVAC does not yet have evidence that the vaccine will be adequate. immune response to be protective above all. The group has begun conducting studies to answer this question, some of which are being conducted in the Harvard laboratory of geneticist George Church, who has already taken two doses of the vaccine. (Estep is a former graduate student and current collaborator in the Church laboratory.)
“I think we are at a much greater risk than COVID [than from the experimental vaccine], consider how many ways you can get it, and how variable the consequences are, “the Church told the MIT Technology Review. The Church added that, while believing the vaccine is safe (in the absence of data showing that is the case), he thinks the “biggest risk is that it won’t be effective.” (The Church is also head of the Harvard Woolly Mammoth Revival team, whose goal is to insert extinct mammoth genes into the DNA of Asian elephants.)
But regardless of whether the vaccine is given protection against coronavirus, vaccines always carry some risk of side effects. The more than 30 candidate vaccines against COVID-19 being tested in sanctioned clinical trials must pass several rounds of efficacy and safety tests for approval, Live Science previously reported. In early trials, vaccine developers see acute side effects that occur shortly after vaccine administration, which may include swelling, redness, and pain at the site of administration, or potentially fever. In advanced clinical trials, they can monitor for side effects that may arise when a vaccinated person is exposed to the virus in a real-world scenario.
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A possible side effect on exposure is known as antibody-dependent enhancement (ADE); this rare phenomenon paradoxically leaves the body more vulnerable to severe post-vaccination infection, and has been previously observed in animal studies on coronavirus vaccines related to SARS-CoV-2, the virus that causes COVID-19, Live Science previously reported.
Self-experimentation with the RADVAC vaccine is “not the best idea – especially in this case, you can pick things up” by triggering the ADE, George Siber, the former head of vaccines at Wyeth pharmaceutical company, told the MIT Technology Review. “You really want to know what you’re doing here.”
Siber added that, considering the vaccine’s ingredients and its route of nasal administration, he is not sure that the vaccine is potent enough to be protective, even if it is safe.
RADVAC published a White card details the prescription for the vaccine in July, with a disclaimer stating that anyone using the information must be a consenting adult, based in the United States, 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 administer a substance is an act of self-experimentation,” the legality of which may varies depending on where you live.
Under the denial statements in the paper, the group describes the formulation of the vaccine, which contains short fragments of a protein, called peptides, found on the coronavirus. These peptides cannot cause COVID-19 alone, but in theory should be recognized by the immune system and promote the building of antibodies which can target and activate the virus. That said, Estep called Siber about the vaccine earlier this year and Siber told him that short peptides do not consistently elicit a strong immune response, according to the MIT Technology Review.
In addition to peptides, the RADVAC vaccine contains chitosan, a substance found in shrimp shells such as shrimp, according to the white paper. Chitosan is thought to cover peptides and alleviate their delivery through nasal mucosal tissue, MIT Technology Review reported. RADVAC developers have chosen to deliver their vaccine in a nasal spray, rather than by injection, in an attempt to trigger a strong, localized immune response in the nose, where COVID-19 infection often enters.
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Mucous tissues, such as those of the nose, have their own specialized fleet of immune cells that help protect tissues that are slightly permeable to debris and pathogens, Live Science previously reported. Ideally, an effective COVID-19 vaccine can trigger both this localized immune response and a systemic immune response throughout the body. Some experts share RADVAC’s view, considering that nasal COVID-19 vaccines are more protective than those that can be injected, The New York Times reported. However, Siber told the MIT Technology Review that he is unaware of any existing vaccines that are based on both peptides and given by the nose; studies are needed to confirm that such vaccines can reliably elicit a healthy immune response.
While the underlying theory may be true, the efficacy of individual vaccines can only be demonstrated through rigorous analysis of the body’s immune response. RADVAC has not completed such studies.
After presenting no evidence that the vaccine provides protection against COVID-19, or that it is safe to administer, the researchers have already distributed vaccine materials to others in their social settings.
“We delivered material to 70 people,” Estep told the MIT Technology Review. “They have to mix themselves up, but we haven’t had full reporting on how much they’ve taken.”
Originally published on Live Science.