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Johnson & Johnson emphasized that so-called adverse events (illnesses, accidents, and other negative medical outcomes) are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical suspension, which is a formal regulatory action. that can last much longer. The vaccine study is not currently on clinical hold. J&J said that while it normally communicates clinical holds to the public, it generally does not inform the public about study breaks.
The data and security monitoring board, or DSMB, met Monday night to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo.
Although pauses in clinical trials are not uncommon, and in some cases last only a few days, they are generating a lot of attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19.
