COVID-19: ‘Serious Adverse Event’ (SAE) that can pause an experimental vaccine explained

As on October 12, Johnson & Johnson temporarily paused its experimental COVID-19 vaccine trials following "an unexplained illness in a study participant” in a recent announcement, the question of adverse events during the routine clinical practices have emerged among the volunteers. According to the US Food and Drug Administration, a serious adverse event from clinical trials would be any “undesirable symptoms” associated with the use of a medical product on the participants with series of life-threatening or mild outcomes. 

While there are non-serious adverse event and Serious Adverse Events (SAEs) with respect to clinical trials according to the Clinical and Translational Science Institute, both, or either create obstructions with respect to safety and efficacy of the tested product as per the Federal mandate. "Protecting safety is an institutional mandate, and is often one of the protocol objectives when testing new therapies so adverse event data must be collected and reviewed by the Principal Investigator,” the CTSI explained in a report.

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The SAE’s also determine the clinical product, for example, a vaccine’s risk versus benefit ratio. Further, the untoward medical occurrence associated with its use can have series outcomes such as prolongated hospitalization, substantial disruption of a person's ability to conduct normal life functions, permanent or temporary body function impairment, or can even jeopardize participant’s health in a way it would require medical or surgical intervention (treatment) to prevent one of the other outcomes, or death, as per US FDA. 

AstraZeneca's SAE pause to vaccine trial

Earlier, in one such Phase, 3 clinical trials of the COVID-19 vaccine being developed by the AstraZeneca and the University of Oxford, the pharmaceutical firm had to put a hold on tests due to a serious adverse reaction event that was reported in a participant in the UK. A spokesperson for AstraZeneca said in an official online statement that the company’s “standard review process triggered a pause to vaccination to allow the review of safety data.” Although the firm did not make the nature of the adverse reaction and its outcomes on the volunteer known. While Clinical holds due to such SAEs are common, researchers often employ the Data and Safety Monitoring Board to ascertain that these SAEs were not life-threatening and were subject to elimination from the product. 

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