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Bad news out front vaccineAfter the pharmaceutical AstraZeneca, the American multinational Johnson & Johnson was also forced to stop work due to an adverse reaction developed in one of the volunteers who had decided to try the product.
Not many details about the episode have yet been reported, especially to respect the privacy of the person concerned: the press was only informed that after undergoing the experimentation, the patient fell ill suddenly and now a special committee is in charge of monitoring his state of health. 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 and expected to enroll about 60,000 identified persons. 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 planned when conducting clinical studies, so there are very specific guidelines to respect. 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 an investigational drug.”, the 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 and Johnson, also because, as the “Wall Street Journal”, its Sars-Cov-2 vaccine 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 American company had previously se indicated that the phase 3 trial would begin to yield results at 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 disease developed by either voluntary or unrelated to the vaccine.
“The Clinical Trial Participant’s illness is assessed by the Independent Data Security Monitoring Board (DSMB) and our internal staff.“The company declared again in a press release, reported by the” Corriere della Sera “. “Adverse events, such as illness or accidents, even serious ones, are part of every clinical study, especially if it is on a large scale.”
