AstraZeneca announced it had resumed clinical trials of the coronavirus vaccine in Britain which had been halted after one volunteer had had a severe adverse reaction. The pharmaceutical giant explained that it had been authorized to resume the trial from all British regulatory bodies.
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The investigation
To evaluate the safety of the vaccine, a committee of independent experts was appointed with the aim of determining whether the adverse reaction of one of the participants, a woman who developed transverse myelitis, was caused by the vaccine or if it was to be considered an event. random. The evaluation process, which must determine what caused the volunteer symptoms, it can take up to six months in standard procedures, much depends on the complexity of the case. The investigation by the independent Committee instead concluded in record time and as a result the experts and the Medicines Health Regulatory Authority (Mhra), the British regulatory body, gave the go ahead to continue the experimentation, the clinical trials will restart throughout the country. So far, about 18,000 volunteers have received the vaccine administration in Great Britain alone.
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The comment of Minister Speranza
The resumption of the Astrazeneca vaccine trial is good news. But a lot of caution is still needed. Science at work to give the world safe and effective treatments and vaccines. In the meantime, the real key continues to be the behavior of each of us, commented the Minister of Health, Roberto Speranza.
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Because the times were fast
If in such a short time the experimentation resumed its path, it means that it was obviously something not related to the vaccine or not so serious and it was easy to understand. Really better so he comments Sergio Abrignani, immunologist, full professor of General Pathology at the State University of Milan. It is not common that a stop is announced for something that is then resolved in three days – adds Abrigani – but this is another sign of the spasmodic attention that the whole world has on the advancement of anti-Covid vaccines. This is not a game – he adds Piero Di Lorenzo, CEO of the Irbm Research Institute in Pomezia, involved in vaccine research – and scientists take responsibility for the world. The lack of relationship between the vaccine candidate and the adverse event was evident, given that the commission expressed its opinion within 24 hours of the meeting. It really means that there is not the slightest doubt. Had it been controversial, the commission would have taken much longer. The times were indeed very fast in analyzing the suspected adverse reaction. There are obstacles in the path of a vaccine candidate. This time publicity was given to the thing precisely to avoid conspiracy, since it is an experiment at the end – underlines Di Lorenzo – But when a Phase 3 trial is done, since they are not healthy volunteers, but also with important pathologies, physiological and routine that there may be adverse manifestations. In this case, if there had been even a doubt, the commission would have taken a lot more time. Filippo Drago, professor of Pharmacology and director of the Clinical Pharmacology Unit of the Policlinico di Catania clarifies what happened: The independent committee in charge of evaluating adverse events received the grade 3-4 report, which provides for the suspension of the trial because the event adverse judged “important”. But on the same day the patient recovered without consequences and the event was downgraded and it quickly became clear that the problem was not the vaccine. If serious adverse events occur, companies cannot hide it for transparency reasons.
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Another stop in July
As early as July, the trial (then in phase 1) was stopped after a participant exhibited neurological symptoms. However, the experimentation was resumed shortly after. After further examination, that candidate was diagnosed with multiple sclerosis, deemed unrelated to the treatment of the Covid-19 vaccine.
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Hopes for the vaccine within the year
During the press conference that was held on Thursday, the general manager of the group, Pascal Soriot declared that an interruption of the trial like this is not abnormal but has a great media coverage given the interest that is around this vaccine, considered one of the most promising to the world. The pharmaceutical company has estimated that it is still possible to have the vaccine by the end of the year or early 2021.
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12 September 2020 (change 12 September 2020 | 19:28)
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