The British laboratory AstraZeneca will thus relaunch the development of its AZD1222, developed with the University of Oxford, the FDA, after analyzes of the safety data having in fact concluded that the trial has been resumed.
“The restart of clinical trials around the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic. We must be reassured by the care taken by independent regulators to protect the public and to ensure that the vaccine is safe before it is approved ” said Pascal Soriot, CEO of AstraZeneca, recalling that his suspensions have nothing “Unusual”.
The trial was suspended on September 6, following the appearance of neurological damage, in one of the 30,000 participants in the study.
On the other side of the Atlantic, the American Johnson & Johnson is also preparing to resume recruitment of the pivotal phase III trial of its vaccine candidate, which was interrupted in early October, due to “Unexplained illness in a study participant”.
The independent data security and monitoring committee (DSMB) has indeed recommended the resumption of trial recruitment. The two laboratories, however, have not communicated on the timetable for the results.
Source link by https://www.industriepharma.fr/covid-19-astrazeneca-et-j-j-reprennent-leurs-essais-cliniques,113834
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