AstraZeneca’s COVID-19 Vaccine Study Being Investigated Further by US FDA; EU Regulator Starts “Rolling Review” to Expedite Approval

The US Food and Drug Administration (FDA) has widened its investigation of a serious illness arising in AstraZeneca Plc’s (Cambridgeshire, England) COVID-19 vaccine study, according to a report by Reuters.

AstraZeneca is conducting trials of its adenovirus vector-based COVID-19 vaccine candidate, AZD1222, developed by the University of Oxford (Oxford, UK). In September, AstraZeneca had confirmed that a participant in the Phase 3 trial of the company’s experimental COVID-19 vaccine candidate developed a serious spinal inflammatory disorder called transverse myelitis, forcing it to halt the study. Sources familiar with the details told Reuters that the FDA would look at data from earlier trials of similar vaccines developed by the same scientists. According to Reuters’ sources, the FDA aims to determine whether similar side effects had been experienced in trials of other vaccines designed by researchers at Oxford University.

With the FDA widening the scope of its probe, AstraZeneca’s COVID-19 vaccine, which is among the front-runners in the COVID-19 vaccine race, is likely to face additional delays. The requested data was expected to arrive this week, after which the FDA would require time to analyze it, the sources told Reuters. In a statement, AstraZeneca said, “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.”

Meanwhile, regulators in the UK, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials in those regions. Clinical trials of AstraZeneca’s experimental COVID-19 vaccine have also resumed in Japan. Additionally, European regulators have begun an accelerated review of AstraZeneca’s COVID-19 vaccine, announcing the start of a so-called “rolling review,” confirming a recent Bloomberg report. Such assessments are generally used in health emergencies in order to allow regulators to examine clinical trial data even as the development continues to speed up approvals. The EMA said it was starting the review based on preliminary results although it did not mean “that a conclusion can be reached yet on the vaccine’s safety and effectiveness.”

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