Coronavirus, suspected adverse reaction. Oxford vaccine trials discontinued. Astrazeneca: “Routine action, we must investigate”

As scientists have been repeating for weeks, it is important that trials with potential vaccines, even the most promising ones, fully complete Phase III of the trial. This is to allow testing for complete safety as well as the efficacy of the compound. Hence the need for at least 30,000 people to be subjected to controls. Today comes the news that AstraZeneca has suspended all clinical trials on the vaccine for the coronavirus that is developing with the University of Oxford after one of the participants serious potential adverse reaction. The temporary stoppage allows the pharmaceutical giant to examine the case and review the safety data. The first studies involving 1087 people were reassuring because the participants reacted well to the administration and some reactions, such as headache or fever, were managed with paracetamol. “Our standard test review process caused a pause,” says an AstraZeneca spokesperson. “Is about a routine action what happens whenever there is one potential unexplained reaction in one of the textst ”which allows time to“ investigate and ensure at the same time that the integrity of the testing process is maintained, ”adds s. “In broader tests, reactions may occur by chance, but must be independently and carefully evaluated,” adds the pharmaceutical giant, which with the suspension announcement immediately suffered a Wall Street loss in after-hours trading. .

A suspension is not unusual for clinical trials. But the development of the coronavirus vaccine is one of the most watched in history, and any signs from testing have come under scrutiny with the magnifying glass. Even if the AstraZeneca vaccine is eventually approved, this setback could translate into usage concerns. Data from the initial trials looked very promising, with the vaccine capable of produce a robust immune response and only mild side effects. AstraZeneca’s stop comes in the ongoing debate about a possible politicization of the vaccine, especially in the United States, where Donald Trump is pushing it ahead of the November elections amid doubts from experts. Not least those of Anthony Fauci, the American scientist, according to whom it is unlikely that a vaccine will be ready by the end of the year. “We are unlikely to have a definitive answer“On the safety and efficacy of a vaccine by the end of the year,” Fauci said at an online research event. The vaccine race is not just an American political issue, it has seemed and appears to be a kind of new cold war between Russia, China and the United States. “The reverse of the AstraZeneca vaccine in Oxford is physiological and normal, it is not a stop but an evaluation phase, a vaccine has never been developed in a year, it takes more than three years – explains 24 Mattino on Radio24 Andrea Crisanti, Professor of Microbiology at the University of Padua – The process is long and complex, the development of a vaccine takes about 5 years. The efforts are justified because it is a measure that is more convenient from the point of view of cost and effectiveness, but it takes time ”.

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