Johnson & Johnson suspends the study of the COVID-19 vaccine due to unexplained disease in the participant

News

Johnson & Johnson suspends the study of the COVID-19 vaccine due to unexplained disease in the participant

16.10.2020 News

Shares of the Johnson & Johnson may slow because the last stimulus to it was the company’s transition to the final clinical trial of the vaccine against COVID-19 on September 23, after which the shares rose by more than 5%. However, as of Tuesday, before the opening of trading, the price of J&J shares did not change significantly.

In the interview with STAT on Monday, J&J announced the termination of its large-scale study involving 60,000 patients due to “unexplained disease of the participant”.

The company did not disclose details, referring to the confidentiality of the volunteer’s data and did not predict how long this stop would last.

According to the representative of the J&J, before resuming the late stage of the study, it is necessary to conduct “thorough analysis of all medical information.”

The company said the clinical trials of the vaccine were not currently being conducted “The termination rule was followed and the online system which is used to include patients in the study has been closed. ”

To investigate the case of the J & J, the independent committee of the data monitoring and security commission will be established, to determine whether the vaccine was the cause of the disease in the patient, or the unexplained disease could develop independently from the vaccine.

The company said that in such cases, “it is not always immediately apparent” whether the participant received, who has adverse symptoms, the study treatment or placebo.

However, representatives of Johnson & Johnson pointed out that discontinuation of the study in the event of adverse symptoms or adverse medical cases is normal practice and is quite common, especially considering the magnitude of the study.

Serious side effects are also “not uncommon in the clinical trials,” J&J said.

J&J said that while the company usually informs the public about clinical data, but it does not usually inform the public about pauses in the research.

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