“Unexplained disease in a volunteer”

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Bad news on the front vaccine, after the pharmaceutical company AstraZeneca also the American multinational Johnson & Johnson was forced to stop the work due to an adverse reaction developed in one of the volunteers who had decided to test the product.


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anthology


Many details have not yet been reported regarding the episode, above all to respect the privacy of the person: the press was only told that after undergoing the experimentation, the patient suddenly became ill and now a special committee is taking care of monitoring his health conditions. This, at least, as reported by the “Wall Street Journal”, which also explains how the company has decided to stop all research on the vaccine, including the phase 3 study started last September which planned to enroll about 60,000 people identified both in the United States than in other countries.

In any case, the company has specified that diseases and side effects they have always been foreseen when clinical studies are carried out, and precisely for this reason there are very specific guidelines to be respected. These guidelines “ensure that our studies can be suspended if an unexpected serious adverse event is reported that could be related to a vaccine or drug under investigation,” the experts say, “so there may be a careful review of all medical information before deciding whether to restart work “.

A real cold shower that came from Johnson & Johnson, also because, as explained by the “Wall Street Journal”, its vaccine against Sars-Cov-2 was one of the most advanced in development, and among the few that reached the last stage of testing, such as AstraZeneca, Moderna Inc . and Pfizer Inc. The executives of the US company had previously stated that the phase 3 trial would begin to yield results by the end of this year, or at the latest in the first months of 2021. Since last Monday, however, everything has stopped. and it is up to the safety committee to assess whether or not the disease developed by the volunteer is related to the vaccine.

“The illness of the participant in the clinical trials is subject to evaluation by the independent Board for the monitoring of data security (DSMB) and by our internal staff”, declared the company again in a press release, reported by “Corriere della Sera” . “Adverse events, such as illness or accidents, even serious ones are included in every clinical study, especially if large-scale”.

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