Ingredients arrive by mail and are prepared by the recipient at home or in the laboratory. No, this is not a DIY meal kit. This is an unidentified COVID-19 vaccine distributed by a group called Rapid Deployment Vaccine Collaborative, or RADVAC, and no one knows if it will actually work. MIT Technology Review reported..
This joint study, consisting of more than 20 scientists, technologists, and “science enthusiasts” from Harvard University and MIT, prior to designing or disseminating the vaccine, had the US Food and Drug Administration Did not seek (FDA) approval. My nose. According to the MIT Technology Review, the group did not seek the approval of the Ethics Committee before launching the project and volunteering as their own subject for what might be considered an informal clinical trial. They also distributed vaccine material to dozens of their social circles.
The FDA did not immediately answer the question from MIT Technology Review regarding whether this initiative could be considered legal. But Preston Estep, a geneticist who founded RADVAC and was its principal scientist, said the FDA would not be in control of the project because the participants would mix and manage vaccines jointly without paying for it. It is still unclear if the FDA will intervene to regulate the project, especially if more people will learn about vaccines and take them.
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“I don’t recommend changing your behavior if you’re wearing a mask, [the vaccine] Estep told the MIT Technology Review. But RADVAC still has no evidence that the vaccine will prompt enough Immune reaction To protect. The group has begun research to answer that question, and some are being conducted at the Harvard Institute of Genetics George Church, and he is already taking two doses of the vaccine. (Estep is a former graduate student and current collaborator at Church’s lab.)
“We think the risk of COVID is very high [than from the vaccine], Considering the number of ways we can get it and how volatile the results are,” Church told the MIT Technology Review. “The greater risk is ineffectiveness.” (Church is also responsible for the Woolly Mammoth Revival team at Harvard University, whose purpose is Insert extinct mammoth gene into Asian elephant DNA.. )
However, regardless of whether the vaccine confers protection against coronaviruses, the vaccine always carries the risk of side effects. Over 30 candidate COVID-19 vaccines that have been tested in licensed clinical trials must undergo several efficacy and safety tests in order to be approved. Previously reported live sciences.. In early trials, vaccine developers will monitor acute side effects that occur shortly after vaccination. This may be swelling, redness, pain, or fever at the site of administration. Advanced clinical trials can monitor the side effects that can occur when a vaccinated person is exposed to the virus in a real-world scenario.
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One side effect that can occur during exposure is known as antibody-dependent enhancement (ADE). This unusual phenomenon paradoxically leaves the body More Previously observed in animal studies of vaccines against coronaviruses that are vulnerable to severe infections after vaccination and are associated with SARS-CoV-2, a virus that causes COVID-19, Previously reported live sciences..
Self-experimenting with the RADVAC vaccine is “not the best idea, and it can make things worse, especially in this case,” said George Shiver, former vaccine head of the pharmaceutical company Weiss, told MIT Technology Review. It was “You really need to know what you are doing here.”
Shiber also doesn’t know if the vaccine is safe enough, even if it’s safe, given the components of the vaccine and the nasal route of administration.
RADVAC is White paper Everyone who uses the information to detail vaccine recipes in July, Information, Vaccines, and Production and Management. In addition, anyone who visits the site must first “acknowledge and agree that using that information to develop and self-manage a substance is an act of self-experiment,” and its legality is It may vary depending on the area of ​​residence.
Under the disclaimer of the paper, this group describes the formulation of vaccines containing short protein fragments called peptides found in coronaviruses. These peptides cannot cause COVID-19 by themselves, but in theory they are recognized by the immune system, antibody It can target and inactivate viruses. According to the MIT Technology Review, Estep called Siber earlier this year about the vaccine, and Siber told him that short peptides don’t always trigger a strong immune response.
According to the white paper, the RADVAC vaccine contains, in addition to peptides, chitosan, a substance found in shrimp-like crustacean shells. Chitosan is intended to be coated with peptides to facilitate delivery from nasal mucosal tissues, according to a report from the MIT Technology Review. The developers of RADVAC have chosen to administer the vaccine as a nasal spray rather than an injection, because it provokes a strong local nasal immune response that often causes COVID-19 infections.
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Mucosal tissues, such as the mucous membrane of the nose, have their own special fleet of immune cells that help protect the slightly permeable tissue from debris and pathogens, Previously reported live sciences.. Ideally, an effective COVID-19 vaccine elicits both this local and systemic systemic immune response. Some experts share the views of RADVAC. They believe that the nasally administered COVID-19 vaccine is more protective than the injectable vaccine. New York Times reported.. However, Siber told the MIT Technology Review that it was unaware of any existing nasal vaccines that were peptide-based. Studies are needed to confirm that such vaccines can reliably elicit a strong immune response.
While the underlying theory may prove to be true, the effectiveness of individual vaccines can only be shown through a rigorous analysis of the body’s immune response. RADVAC has not completed such research.
Researchers have already distributed vaccine material to others in their social circles because the vaccine does not provide protection against COVID-19, or offers no evidence that it is safe to administer. Did.
“We delivered the material to 70 people,” Estep told MIT Technology Review. “They had to mix it themselves, but there was no full report on how many people took it,” he said.
Originally published on Live Science.
