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The group of researchers at Oxford University who are in the race to develop a coronavirus vaccine has promised to end clinical trials of the vaccine in August, which has already been applied to 1,100 volunteers in late April. But the European Medicines Agency was skeptical about the promise of having a cure for covid-19 on the market later this year, as the development and licensing of this type of medicine takes longer and, in the More optimistic scenario, this would happen in a year.
In an interview with BBC Radio 4 on Thursday, the university’s professor of medicine and non-executive director of pharmaceutical Roche, Sir John Bell, said that if the Oxford research steps continue to work, the British government will have approved the vaccine early September and began to manufacture it for the population. Now, the group needs to assess whether people who received the coronavirus dose were infected or not, to see if they found a vaccine with the potential to end the pandemic.
On April 23, researchers injected the first 320 volunteers with the ChAdOx1 nCoV-19 vaccine, which is the combination of the chimpanzee adenovirus and the genetic material of a protein found on the surface of the coronavirus, used to infect human cells. Another group received a meningitis vaccine, since the side effects are similar to those caused by ChAdOx1 nCoV-19: elevated body temperature, headache and pain in the arms. Therefore, patients would have no way of knowing which of the two vaccines they received.
To find out if the vaccine works, you should check the statistics of the level of infection in both groups. And for that, it is necessary for a small group to develop the covid-19. And it is at this stage that the researchers are. “The speed with which our team has the necessary numbers (for evaluation) depends on the level of virus transmission in the population. If the transmission is still high, we can have enough data in two months. If the transmission is cut, it could take six months, ”says an April 23 message from Oxford. “By June, we must have enough people with the disease. And, if they have not been infected, it is an advance, ”Bell told the BBC.
Long process
The head of the vaccine department of the European Medicines Agency, Marco Cavaleri, said in a virtual conference that “very few vaccines reach the final licensing process and, in many cases, additional tests are required to confirm that they do not cause any side effects. serious “.
He also noted that it is not possible to rule out a third stage of the vaccine development process, in which the level of protection and side effects are investigated through tests on thousands of people outside the laboratories, leading to the determination, among other factors, if the vaccine makes people more susceptible to contagion.
On the other hand, the agency also has 115 pending clinical trials of symptoms caused by the coronavirus. Cavaleri said some of these trials could be approved in Europe later this year, but did not specify what method it would be. (With international agencies).
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