"AstraZeneca Vaccine US Clinical Trials Still Unable to Resume"

Resumption Schedule Likely After US FDA Investigation Ends
UK and Brazil Health Authorities Approve Clinical Trial Resumption

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] As major foreign media report that AstraZeneca's clinical trials for the novel coronavirus infection (COVID-19) vaccine remain suspended in the United States, attention is focused on the U.S. health authorities' investigation results into side effects. While it is expected that the clinical trials will not resume until later this week, clinical trials have restarted in countries where health authorities such as the UK and Brazil have approved the resumption.

According to CNBC and major foreign media on the 14th (local time), AstraZeneca's COVID-19 vaccine clinical trials remain suspended in the U.S., and the investigation into side effects by U.S. health authorities has not yet been completed. These media outlets, citing sources familiar with the matter, reported that "the investigation into vaccine side effects conducted in the UK has not yet been completed in the U.S."

Previously, AstraZeneca's vaccine clinical trials were fully suspended in the UK after a case of transverse myelitis side effect was found in one patient during the trial. Currently, the Phase 3 clinical trial of AstraZeneca ongoing in the U.S. has had volunteer enrollment and other trial procedures rescheduled to at least midweek or later, and it is unknown how long the U.S. Food and Drug Administration (FDA) investigation will take. AstraZeneca is reported to have avoided commenting on when the clinical trials in the U.S. will resume.

In the UK, where the side effect case occurred, the Medicines and Healthcare products Regulatory Agency (MHRA) and other health authorities completed their investigation and confirmed safety, leading to the resumption of clinical trials. Clinical trials also resumed on the same day in Brazil, while in South Africa and India, where trials are also ongoing, it is not yet known whether they will resume.

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