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AstraZeneca announced that it has resumed clinical trials of the coronavirus vaccine in Britain that were halted after a volunteer had a serious adverse reaction. The pharmaceutical giant explained that it had been authorized to resume the trial by all British regulatory bodies.
The investigation
To assess the safety of the vaccine, a committee of independent experts was appointed to determine if the adverse reaction of one of the participants, a woman who developed transverse myelitis, was caused by the vaccine or if it should be considered an event. random. The evaluation process, which must establish what caused the volunteer’s symptoms, can take up to six months in standard procedures, much depending on the complexity of the case. Instead, the Independent Committee’s investigation was concluded in record time and consequently, experts and the Health Medicines Regulatory Authority (Mhra), the British regulatory body, gave the go-ahead to continue experimentation, clinical trials will be restarted in all the country. So far, around 18,000 volunteers have received the vaccine in Britain alone.
Minister Speranza’s comment
The resumption of the Astrazeneca vaccine trial is good news. But much caution is still needed. Science in action to bring the world safe and effective treatments and vaccines. Meanwhile, the real key continues to be the behavior of each one of us, said the Minister of Health, Roberto Speranza.
Because times were fast
If in such a short time the experimentation got back on track, it means that it was obviously something not related to the vaccine or not so serious and easy to understand. Really better so comment Sergio Abrignani, Immunologist, Professor of General Pathology at the State University of Milan. It is not common for a stoppage to be announced for something that is later 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 – add 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 candidate vaccine and the adverse event was evident, as 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. In fact, the times were very fast in the analysis of the suspected adverse reaction. There are obstacles in the path of a vaccine candidate. This time the thing was publicized precisely to avoid the conspiracy, since it is an experiment in the end – Di Lorenzo emphasizes – But when a Phase 3 trial is done, since they are not healthy volunteers, but also with important, physiological and routine pathologies that there may be adverse manifestations. In this case, if there had been any doubt, the commission would have taken much longer.
Another stop in July
As early as July, the trial (then in phase 1) was stopped after one participant showed neurological symptoms. However, experimentation resumed shortly thereafter. After further examination, that candidate was diagnosed with multiple sclerosis, which was deemed unrelated to the Covid-19 vaccine treatment.
Expect the vaccine within the year
During the press conference held on Thursday, the general manager of the group, Pascal Soriot said that a trial interruption like this is not abnormal but it has a great media coverage given the interest around this vaccine, considered one of the most promising for 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.
September 12, 2020 (change September 12, 2020 | 18:12)
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