FDA expands probe into AstraZeneca Covid-19 vaccine candidate
American health regulators have widened their investigation into the adverse event related to one patient in AstraZeneca's ongoing phase three clinical trial of its Covid-19 vaccine candidate.
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Citing three sources familiar with the matter, Reuters reported that the the Food and Drug Administration, has asked for data from previous trials on similar vaccines conducted by researchers at AstraZeneca.
More specifically, the FDA wanted to ascertain whether trials into other vaccines that use modified adenoviruses from chimpanzees had also resulted in any adverse events.
Reuters said that one of those previous trials had registered a single such occurrence - but it was deemed unrelated to the vaccine.
According to the same sources, that did not mean that the FDA thought that there were safety issues linked to any of the vaccines; rather, one source explained, it showed that it intended to be thorough.
Two of the sources added that it raised the odds of additional delays in the restart of trials for the vaccine in the US.
Furthermore, the FDA reportedly requested the information it sought be sent in a format different from what US regulators ask for.