Large-scale clinical trial J&J has been suspended due to “unexplained illness of the participant of the study”. The company did not give details, citing the privacy of the volunteer, but pointed out that with the participation of 60 000 patients, the suspension is an expected part of the clinical study.
Growth stocks Johnson & Johnson (JNJ) could be slowed, as the final impetus for him was the transition of the company to the final clinical study of a vaccine against COVID-19 September 23, after which the stock rose more than 5%. However, as of Tuesday prior to market open the price of J&J stock has not significantly changed.
Monday interview STAT, J&J announced the suspension of his large-scale study involving 60,000 patients because of “unexplained illness of the participant of the study”.
The company did not disclose details, citing the confidentiality of the volunteer and did not forecast how long will this suspension.
According to a representative of J&J, before resuming late phase research you need to conduct a “thorough analysis of all medical information”.
The company said that at present, clinical trials of the vaccine are not held “rule of pause was observed, and the online system used for inclusion of patients in the study were closed”.
To study the case in J&J will create an independent Committee of the Commission on the data and safety monitoring to determine whether the vaccine is the cause of the disease in the patient, or unexplained disease could develop regardless of the introduction of the vaccine.
The company said that in such cases “are not always immediately visible,” does the party who experienced unwanted symptoms, study treatment or placebo.
At the same time, representatives of Johnson & Johnson pointed out that the suspension of the study in detecting unwanted symptoms or adverse health outcomes – it is normal practice and quite often, especially given the scale of the study.
Serious side effects also “are not uncommon in clinical trials,” said J&J.
J&J said that, although she usually informs the public about clinical data, it usually does not inform the public about the pauses in the research.
8 Sep a major study of other vaccine COVID-19, developed by AstraZeneca and the University of Oxford, has been suspended due to suspected adverse reactions in a patient in the UK. It is believed that the reaction was caused by a patient has transverse myelitis, spinal cord disease. Studies of the vaccine AstraZeneca in the UK resumed about a week after the suspension, but in the United States, while it remains suspended.
In the United States are tested seven candidate vaccines against coronavirus. In addition to J&J, to the final stages of clinical testing pass: Moderna (MRNA), Pfizer (PFE) and BioNTech (BNTX).