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Trials of AstraZeneca are suspended in the US due to reports of serious illness from another volunteer



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Chimpanzee adenovirus-based vaccine testing has been reported to be compromised due to “dangerous” deficiencies in chimpanzee viruses. Another reason is the unclear consequences of using this new technology. Trials with AstraZeneca in the US remain suspended.

A few days after AstraZeneca stopped clinical trials of its covid-19 vaccine due to a case of unclear neurological disease in a volunteer who participated in the trials, the company published a 1

11-page document that promised a coronavirus drug “50% effective”. . There, AstraZeneca first revealed a second participant in the trial who became seriously ill during Phase 3 studies in the UK.

In the UK, the company has resumed the test, despite a volunteer developing transverse myelitis – inflammation of the spinal cord. The diagnosis of the other patient has not yet been confirmed. Nevertheless, the New York Times quoted a well-known source as claiming that another patient had contracted the same disease. However, AstraZeneca has not yet announced this. It turned out that “the first break in July was not announced publicly and tests resumed”, says an article published by The Telegraph.

Despite pressure to conduct in-depth studies after two cases of serious illness were confirmed, AstraZeneca has already resumed testing in the UK, Brazil, India and South Africa. In the United States, however, tests remain suspended after the US National Institutes of Health enters. “Senior officials at the National Institutes of Health are very concerned,” said Dr. Avindra Nath, head of virus research at the National Institute of Neurological Disorders, one of the departments of the US National Institutes of Health, to CNN.

Experts from the US Food and Drug Administration have the same position.

“We are here to protect the American public, we will do a lot of work with the company to find out if there is a major safety risk or not,” said Stephen Hahn, commissioner of the US Food and Drug Administration, during a living social network with the Republican Republic. Senator Tim Scott of South Carolina.

“We do not have all the facts, so we do not know exactly what caused it, but we really have to investigate it. And our main responsibility is the security of American citizens,” Hahn said.

AstraZeneca was reportedly criticized for its lack of transparency by the professional group and the scientific community.

William A. Haseltine, MD, a former professor at Harvard Medical School and Harvard School of Public Health, told Forbes: “The details of the suspension of AstraZeneca testing have not been fully revealed and internal discussions have not been made public. It is good to see that They have suspended testing for patient safety, yet the pharmaceutical company’s lack of transparency is worrying. Should this vaccine save lives and return the world to normal, but is not the public entitled to know the details of drug development progress? People need to know more about what happened when it security. “

Dangerous gambling

In addition to revealing impaired clinical trials of AstraZeneca’s vaccine, the published document revealed the risks associated with relying heavily on new and untested techniques – chimpanzee adenovirus. Compared to the human adenovirus vector, which has been extensively studied and used to make a large number of vaccines and other drugs, the chimpanzee adenovirus has never before been used in any vaccine worldwide. According to Russian researchers, the most important negative aspect here is the absence of a long-term study of these vaccines: no one knows if they risk cancer or affect the ability to produce children.

Human adenovirus-based vaccines are used by a large number of pharmaceutical companies in their development of covid-19 vaccines. These are the Chinese company CanSino and the American company Johnson & Johnson. It is also an already registered Sputnik V vaccine, developed by the Nikolai Gamaleji Institute.

Sputnik V.

On August 11, the Nikolai Gamaleji Institute registered the world’s first vaccine against a new coronavirus: Sputnik V. This occurred after the vaccine had successfully passed two test phases, proving its effectiveness in building immunity to covid. The efficiency was 100%. Russia is currently conducting three phases of testing with 2,000 people.

Sputnik V consists of two injections 3 weeks apart.

The Russian direct investment fund, which is involved in the production of the drug, announced that it will produce 500 million doses of the vaccine next year. Vaccine production will also take place in other countries.

In September, the leading medical journal The Lancet published the results of Sputnik’s Phase 1 and Phase 2 clinical trials. The Lancet concluded that the Russian vaccine was safe and effective without any serious side effects.




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