American company Johnson & Johnson has been working on their federally-directed COVID-19 vaccine for months; however, an unexplained sickness in one of their testing patients has suspended the study.
Their leading candidate for a coronavirus vaccine entered phase three of testing and dosing back in September. Now due to ethical practice concerns, the company will undergo a proper investigation and pausing testing until the matter is cleared up.
“Adverse events even those that are serious, are an expected part of any clinical study, especially large studies,” reads the company update regarding their vaccine trials. “A regulatory hold of a clinical trial is a requirement by a regulatory health authority, such as the U.S. Food and Drug Administration (FDA).”
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Until further notice the current trials will be placed on hold while Johnson & Johnson ensure that the patient’s sickness is not a product of the vaccine candidate.
It is expected that this hold could take a while to be cleared.
“Serious adverse events (SAE) are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”