US Oxford COVID-19 vaccine trails remain halted: FDA clearance pending

By Rahul Vaimal, Associate Editor
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COVID-19 Vaccine
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Oxford University’s COVID-19 vaccine candidate trials still remain halted in the United States as an investigation into a serious side effect reported in the UK last week is yet to clear the usage of the vaccine in the trails. 

The AstraZeneca co-developed vaccine candidate resumed trials in the UK as an independent safety review committee and the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA) gave the approval to continue the trials.

The US trails are only expected to resume post a clearance is issued after the U.S. Food and Drug Administration (FDA) and a safety panel investigate the case.

It is still unclear how long the FDA will take to conduct an investigation and the trials will remain on hold. Global enrollments for new volunteers were put on hold on September 6.  US-specific enrollment of new patients and other trial procedures are also expected to be rescheduled until at least midweek.

The extended delay in the U.S. trial is expected to slow access to one of the most promising cures rated highly by the World Health Organization (WHO).

The UK incident involved a trail volunteer developing a rare spinal inflammatory disorder called transverse myelitis.

An AstraZeneca spokeswoman declined to comment on when the U.S. trial would resume and noted that the firm “will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume.”

South African and Indian trials for the vaccine candidates too remain halted with no date restart announced while the trial in Brazil has restarted.