US scientists inject their own Covid-19 vaccine without prior clinical trial

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“Attention, dangerous practice, do not reproduce. ” Some American scientists decided to experiment on themselves and sometimes their families, their own vaccine” homemade “against Covid-19. While around 200 vaccine projects are underway around the world, their development can be particularly slow. Three phases of testing are necessary before their possible large-scale use and, today, less than a dozen projects have reached the third and final phase, which consists of testing the virus on several thousand human beings.

Too long a delay for the American biologist Johnny Stine, at the head of a biotechnology company in Seattle (Washington State). He developed a vaccine with the genetic sequence of a protein found on the surface of the SARS-CoV-2 coronavirus, which he then simply mixed with saline, reports The New York Times .

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Arguing that “making a vaccine [could] be very simple” , Johnny Stine then injected it under the skin. According to his statements, still reported by the American daily, he would have developed antibodies twelve days after the injection.

Nasal spray vaccine

“I am immune, I administered my own vaccine five times , ” he posted in discussions on Facebook to attract customers. And if his miracle product may seem sketchy and remains not validated by a serious study, the scientist was billing him 400 dollars (about 340 euros) per person – before stopping after legal proceedings launched by the authorities. About 30 people have reportedly received the vaccine, mainly in Washington State. In New York Times columns , molecular biologist and former Johnny Stine boss Patrick Gray warns that “it’s impossible for someone like Johnny to create a viable vaccine . “

Other scientists, with less commercial practices, have also embarked on the development of a vaccine before anyone else. Preston Estep, a geneticist from Boston, set up the RaDVac project (for Rapid Deployment Vaccine Collaborative , “collaboration for the rapid deployment of a vaccine”), in March, with twenty other specialists, most of whom are connected. at Harvard University or the Massachusetts Institute of Technology (MIT). “These are five ingredients that can be mixed in a pharmacist’s laboratory , ” says Preston Estep, in a scientific document justifying his approach .

Its vaccine, in the form of a nasal spray, contains “fragments of the pathogen, here small pieces of protein which correspond, in part, to SARS-CoV-2 but which do not trigger the disease in themselves” , specifies the review technology from MIT . At the end of April, the first version of the vaccine had been tested by all employees and their families. Preston Estep assured the New York Times that the only side effects reported are “stuffy noses and mild headaches . “

The scientist changes his formula as new discoveries about the coronavirus come about: so far, he has administered eight different versions of the product. George Siber, former head of vaccination at an American pharmaceutical company, believes in the technology journal of MIT that “simple small proteins do not trigger a sufficient immune response . ” At the end of July, Preston Estep could not say if the small hundred people (he admits to ignoring) who tested his vaccine had developed antibodies.

Self-experimentation is not prohibited
Under US law, the RaDVac project “operates in a gray area” , according to the MIT review. Normally, testing for a new drug or vaccine requires approval from the Food and Drugs Administration (FDA), the US health authority, but Preston Estep has not requested it. “If you create it yourself and administer it to yourself, the FDA can’t say anything,” he told the MIT review.

Elsewhere, doctors and researchers have also administered their own vaccine against Covid-19. The journal The Scientist mentions in particular the case of the Chinese immunologist Huang Jinhai, who announced that he had inoculated himself with four doses of his product, before it was tested on animals. In Russia, the director of the Moscow-based Gamaleya research institute had tried his vaccine. Unlike the Americans, these projects subsequently incorporated serious clinical studies.

Rediscovered in the era of the Covid-19 pandemic, experimentation with drugs and vaccines on oneself is not, however, new. “In the history of medicine, self-testing has been a particularly recognized tradition ,” says Susan Lederer, professor of medical history at the University of Wisconsin, to the journal. It was almost compulsory; that you were risking your health or that of your children was proof of good faith. ” It is also thanks to self-vaccination that the famous American virologist Jonas Salk and the Russian couple formed by Marina Voroshilova and Mikhail Chumakov have contributed to the fight against polio, specifies the scientific journal.

On the other hand, the scientific community does not see this practice favorably regarding the coronavirus. The development of these “homemade” vaccines seems to respond to a haste linked to the fear of a still unknown virus. And that this often rhymes with approximation and threat to health. Beyond the deleterious effects of these products, not validated by serious clinical trials, they could also produce no effect. In this case, the New York Times warns of a “false sense of protection” which could lower vigilance, at a time when new contaminations are increasing again across the planet .

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