Bad news on the front vaccine, after the pharmaceutical company AstraZeneca even the American multinational Johnson & Johnson was forced to stop work due to an adverse reaction developed in one of the volunteers who had decided to test the product.
Many details have not yet been reported regarding the episode, above all to respect the privacy of the person concerned: 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, according to reports from the “Wall Street Journal”, which also explains how the company has decided to stop all research on the vaccine, including the phase 3 study that began last September which planned to enroll about 60,000 people identified both in the United States and 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 “They 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”, experts say, “therefore 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 Sars-Cov-2 vaccine was one of the most advanced in development, and among the few that arrived at the last stage of testing, such as AstraZeneca, Moderna Inc. and Pfizer Inc. The executives of the US company had in previously stated that the phase 3 trial would begin to give results by the end of the current 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 the disease developed by the whether voluntary is vaccine related or not.
“Clinical Trial Participant’s disease is evaluated by the Independent Data Security Monitoring Board (DSMB) and our internal staff”Stated the company again in a statement, reported by “Corriere della Sera”. “Adverse events, such as illness or accidents, even serious ones are part of every clinical study, especially if large-scale”.
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