Johnson & Johnson Halts COVID Vaccine Tests After Patient Falls Sick
Johnson & Johnson says it is suspending experimental COVID-19 vaccine tests because of an unexplained sickness in a research subject.
The 60,000-participant clinical tests conformed with requirements for a pause policy, doctors said, which means the online system that registers test subjects has been closed and the independent panel that keeps track of safety procedures in the trial will be summoned.
A pause is not totally surprising in vaccine tests. When another test was temporarily halted in September, scientists acknowledged the setback as an example of the complex process that is being sustained despite the growing pressure to produce a safe and effective COVID treatment, Reuters reported.
The clinical tests for that vaccine, spearheaded by Oxford University and AstraZeneca, were restarted a few days later after an evaluation body decided it was safe to commence for the next stage.
Over 190 potential COVID vaccines are being monitored by the World Health Organization, 10 of which are in late-stage studies. Of those 10 candidate drugs in advance-phase trials, there are at present five that are expected to be available in the U.S. if given approval by the Food and Drug Administration.
According to Johnson & Johnson, the subject's illness is being closely examined by an independent safety monitoring body as well as the pharmaceutical group's safety physicians. It is not clear whether the patient was administered with the investigational vaccine or was given a placebo.
Johnson & Johnson said that such pauses, done in compliance with regulatory policies, are normal in major clinical tests, which can comprise tens of thousands of participants.
While clinical tests in Europe, India, Brazil and South Africa have resumed, the U.S. test is still on pause pending a regulatory evaluation.
Almost 38 million people worldwide have been infected with COVID-19, data gathered by the Center for Systems Science and Engineering at Johns Hopkins University showed.