An unapproved “COVID-19 vaccine kit” (neither for efficacy nor for safety) has been distributed by a group called The Rapid Deployment Vaccine Collaborative (or RADVAC), and no one knows if it actually works and what in are the risks. The ingredients of this vaccine arrive by mail, for preparation by recipients, at home or in their laboratory.
The RADVAC collaboration, made up of more than 20 scientists, technologists and “science enthusiasts”, some of whom are affiliated with Harvard University and MIT, has not sought clearance from the Food and Drug Administration (FDA) of United States before conceiving or using a vaccine. The group also did not seek approval from an ethics committee before launching the project and volunteering with its own test subjects in what could be considered an unofficial clinical trial, according to the. MIT Technology Review. Members also distributed vaccine materials to dozens of individuals 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 is its chief scientist, said the FDA does not have jurisdiction over the project because participants mix and administer the vaccine themselves, without paying a fee. collaboration in exchange. It remains to be seen whether the FDA could step in to regulate the project, especially as more and more people learn of the existence of this experimental vaccine and take it. ” We are not suggesting that people change their behavior if they are wearing masks, but [le vaccin] potentially provides multiple layers of protection ”Said Estep. However, at this time, RADVAC does not yet have evidence that the vaccine elicits an adequate immune response to be protective against COVID-19 disease.
The group began to conduct studies to answer this question. Some of these studies are being conducted in the Harvard lab of geneticist George Church, who has already taken two doses of the vaccine. (Note that Estep is a former graduate student and current Church lab collaborator). ” I think we are at a much greater risk with COVID [qu’avec le vaccin expérimental], taking into account all existing forms of the disease and the variability of the consequences Church said. He also added that although he thinks the vaccine is safe (in the absence of data to prove it is), he believes that “the greatest risk is that it is ineffective. ».
Whether or not this experimental vaccine provides protection against the coronavirus, it should be noted that vaccines always carry a certain risk of side effects. The more than 30 COVID-19 vaccine candidates tested in clinical trials must undergo multiple rounds of efficacy and safety tests to be approved. In early trials, vaccine developers watch for acute side effects that occur soon after vaccine administration, which may include swelling, redness, and pain at the administration site, or potentially fever. . In advanced clinical trials, they can monitor side effects that may occur when a vaccinated person is exposed to the virus in a real scenario.
A side effect that could occur during exposure is known as the facilitation of infection by antibodies (or ADE, from English Antibody-dependent enhancement): a rare phenomenon that paradoxically makes the body more vulnerable severe infections after vaccination, and which has already been observed in animal studies of vaccines against coronaviruses linked to SARS-CoV-2, the virus that causes COVID-19.
Therefore, self-experimenting with the RADVAC vaccine is not ” not the best idea – especially in this case, as you could make matters worse by triggering the ADE Said George Siber, the former head of vaccines at pharmaceutical company Wyeth. “ You really need to know what you are doing here “, he added. Siber also added that, considering the ingredients of the vaccine and its route of administration (through the nose), it is not sure whether it is potent enough to be truly protective, although it does prove to be safe. .
In July, RADVAC released a white paper detailing the vaccine recipe, with a disclaimer stating that anyone using this information must be a consenting adult, based in the United States, who agrees to “take full responsibility. »The use of this information, the vaccine and the materials required for the production and administration of the vaccine. RADVAC also added that, in addition, anyone accessing the site must first “ recognize and accept that any use of this 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.
Under the disclaimers in the document, the group describes the formulation of the vaccine, which contains short fragments of proteins, called peptides, found on the coronavirus. These peptides cannot cause COVID-19 disease on their own, but in theory should be recognized by the immune system and induce the construction of antibodies capable of targeting and inactivating the virus. That said, according to the MIT Technology Review, Estep called Siber about the vaccine earlier this year, and Siber reportedly told him that short peptides don’t always elicit a strong immune response.
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In addition to peptides, the RADVAC vaccine contains chitosan, a substance found in the shells of crustaceans like shrimp, according to the white paper. In this case, the chitosan is intended to coat the peptides and facilitate their delivery through the mucous tissues of the nose. The developers of RADVAC have chosen to administer their vaccine through a nasal spray, rather than by injection, with the aim of triggering a strong immune response localized in the nose, where COVID-19 infection often sets in. in the first place.
Note that mucous tissues, like that of the nose, have their own specialized fleet of immune cells that help protect somewhat permeable tissues from debris and pathogens. Ideally, an effective COVID-19 vaccine would trigger both this localized immune response and a systemic immune response throughout the body. Some experts share RADVAC’s point of view, in that they believe that COVID-19 vaccines given through the nose would be more protective than injectable vaccines.
However, Siber told the MIT Technology Review that he was unaware of any existing vaccine that was both peptide-based and administered through the nose: studies would be needed to confirm that these vaccines could reliably elicit a robust immune response. While the underlying theory may prove to be true, the effectiveness of individual vaccines can only be demonstrated by careful analysis of the body’s immune response. And for now, RADVAC has not completed such studies.
It is by not presenting any evidence that the vaccine offers protection against COVID-19, or that it is safe to administer, that researchers have already distributed materials for the vaccine to individuals in their social circles. . ” We delivered equipment to 70 people. They have to mix it up themselves, but we haven’t had a full report on how many people have taken it. ”Said Estep.