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The words of Piero Di Lorenzo, director general of the Pomezia Research Institute, on the restart in Oxford of clinical trials for the AstraZeneca vaccine
“We have been anxiously but confidently waiting for this answer,” he sighs in relief. Piero Di Lorenzo, CEO of Irbm of Pomezia, speaking with Adnkronos about the news of the restart of clinical trials of the Covid-19 vaccine, which has reached the last phase of testing at the University of Oxford.
Covid Vaccine, Clinical Trials Resume in Oxford After Stop
The Research Institute is the Italian component of this project, fundamental in the realization of the candidate vaccine among the most advanced in the world, developed by the English University with the pharmaceutical giant AstraZeneca.
Phase III had been disrupted last Wednesday because one of the patients had had a serious “adverse reaction”. But in just three days, the same company announced that it had received permission to operate again.
A committee of independent experts was tasked with examining the woman who developed transverse myelitis in the course of testing, in order to determine whether the side effect was caused by the vaccine itself or an independent cause.
“Is it’s not a game. Scientists take responsibility for the world. The lack of relationship between the candidate vaccine and the adverse event was evident, as the committee expressed its opinion within 24 hours of the meeting. It really means that there is not the slightest doubt. If it had been a controversial event, the commission would have required much more time, “explained Piero Di Lorenzo,” perhaps months. Instead, everything went very fast. “
In this case, only some days conclude the investigation of the independent Committee, with the green light of the Medicines Health Regulatory Authority (Mhra), institute that grants authorization for trials in Great Britain.
Covid vaccine, the CEO of Pomezia Irbm speaks: “No relationship”
“There are obstacles in the way of a candidate vaccine. This time, the thing was publicized precisely to avoid the conspiracy, since it is an experiment in the end – clarifies the managing director of Irbm – But when a Phase 3 trial is done, since they are not healthy volunteers, but also with important pathologies, it is physiological and routine that there may be adverse manifestations. Then, in 99.9% of cases it is shown that there is no relationship with the vaccine candidate. In this case, if there were only one doubt the commission would have taken much longer ”.
“It would be hypocritical to say that it escaped me – Di Lorenzo confesses – but I was very confident because my scientists told me over and over again that the job looks good, it is well done.”
Now we start with the next step in the development of the candidate vaccine, since it refers to: “The enrollment of new volunteers resumes rapidly after a 3-4 day suspension. Although nothing changes for the 50,000 volunteers already vaccinated who are monitored and will continue to be, an activity that has never stopped ”.
VIRGILIO NEWS | 09-13-2020 19:59
Photo Source: Ansa
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