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The trials were suspended due to illness in one of the subjects. It is not reported what exactly happened to him.
The pharmaceutical company AstraZeneca and the University of Oxford have resumed clinical trials of a COVID-19 coronavirus vaccine, suspended due to the “potentially unexplained” illness of one of the subjects.
The independent authorities responsible for the safety of the study reviewed the case and decided that the vaccination could be continued. However, the suspension, experts say, is a reminder that COVID-19 is uncharted territory. Correspondent.net says the details.
The timeline has been delayed to 2022
In April this year, Sarah Gilbert, a vaccination professor at Oxford University in charge of the coronavirus vaccine, said she was 80 percent confident that her team would be successful in creating a vaccine by September. A few years ago, Gilbert created the MERS (Middle East respiratory syndrome) vaccine.
The American New York Times wrote in those days that Oxford was ahead of the rest of the competition and “was the recognized leader of the race.”
Within weeks, Oxford signed a partnership deal with British pharmaceutical giant AstraZeneca, after which both parties literally rushed to conclude contracts around the world for the production and distribution of hundreds of millions of doses of the future vaccine.
At that time, this vaccine became one of the greatest hopes for many countries in the world: at the end of the project, orders for this vaccine surpassed its closest competitors (the total number almost reached the three billion dose mark. ).
In late August, AstraZeneca was reported to have started clinical trials with 30,000 volunteers in the United States, and fewer groups of volunteers started receiving the drug in the United Kingdom, Brazil, and South Africa.
However, on September 6, the clinical trials were frozen on September 6 due to the illness of one of the volunteers. What health problems were identified in one of the volunteers, the British did not report.
However, according to the American newspaper New York Times, the patient was diagnosed with transverse myelitis, a fairly rare inflammatory disease of the spinal cord, which is often caused by viral infections.
On September 12, it became known that the Oxford coronavirus vaccine will be retested in volunteers. The UK Health and Medicines Administration (FDA) eventually concluded that it was safe to continue testing.
“During large-scale trials, some participants may become ill, and each of those cases must be carefully evaluated to track full compliance with safety measures,” the University of Oxford said in a statement.
The experts noted that such hurdles are not particularly unexpected in the vaccine development process.
By pausing testing to remedy the situation, AstraZeneca has sent a good signal: it is a signal that the system is working as it should, that pharmaceutical companies comply with all safety requirements, that there are certain scientific regulations and that the political leadership you are not trying to exert pressure.
As noted by Charlotte Summers, a researcher at the University of Cambridge, Oxford has shown a desire to “make safety a top priority in its research program.”
Professor Gilbert’s predictions were more a reflection of “pride than reality,” said Michael Kinch, director of the Centers for Innovation in Biotechnology Research and New Drug Development at Washington University in St. Louis.
“The reality is that developing a vaccine … is generally quite a difficult task. Often, you simply cannot foresee the big problems,” Politico said, quoted by him.
Note that adenoviral vector vaccines, such as the Oxford vaccine, are relatively new, and mRNA vaccines, such as those developed by Moderna and Pfizer, have never been used in humans before.
The development of a coronavirus vaccine is underway in many countries. The World Health Organization recently reported that nearly 180 vaccine variants are currently being tested.
Last week, the Russian coronavirus vaccine entered circulation. The start of mass vaccination of Russians is scheduled for October. At the same time, the third phase of clinical trials will take place.
The published results of the studies of the Russian drug, a group of scientists from the United States, Italy and other countries published an open letter in which they announced the discovery of statistical anomalies in an article on the Russian vaccine against coronavirus. About this in detail in the material Already in circulation: what is known about the Russian vaccine.
According to some reports, the Trump administration plans to begin distributing Moderna and Pfizer vaccines in the United States, which are now in the third phase of clinical trials, in early November.
Ukraine is negotiating with the developers of the COVID-19 vaccine and is ready to place an order and prepayment as soon as it is registered, Health Minister Maxim Stepanov said on September 12.
“When a vaccine appears, not a single person in the world knows about it. Now the clinical trials are ongoing, they are in the third stage … We are trying to agree that the vaccine will appear in Ukraine as soon as possible after its registration.” Stepanov said.
He added that, first of all, representatives of risk groups should be vaccinated: patients with diabetes, cardiovascular and lung diseases, as well as medical workers.
However, the WHO believes that even if a vaccine is successfully developed, it will have to be fully tested and is unlikely to be approved this year.
France-Press writes that AstraZeneca expects the vaccine to be ready “by the end of this year or early next.” However, the University of Oxford does not exclude that the world will not see the drug until 2022.
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