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US FDA Investigating AstraZeneca's COVID-19 Vaccine Trial, Says Chief

US FDA said that AstraZeneca’s vaccine trial in America is still on hold and the officials are working to figure out if there was a safety issue or not.

US FDA

The US Food and Drug Administration (FDA) on September 16 said that AstraZeneca’s COVID-19 vaccine trial in America is still on hold and the officials are working with the company to figure out if there was a significant safety issue or not. Frontrunner AstraZeneca halted its largest COVID-19 vaccine trial last week after a patient volunteering for the vaccine trial fell ill. 

While the UK-based company is still trying to investigate whether the sudden illness of a candidate is a serious side effect of the vaccine, Commissioner Stephen Hahn said that FDA is still looking into it. In an Instagram live session with Senator Tim Scott, Hahn said that the officials don’t have all facts yet and they don’t know the causation per se. However, he added that the ‘prime responsibility’ is the safety of the American people.

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AstraZeneca pauses trial 

The US trial remains on hold as the FDA and safety panel is still investigating the case. AstraZeneca, which is developing a COVID-19 vaccine in partnership with Oxford University, announced that it had paused its vaccine trial on September 6. The US health news site STAT first reported the pause in testing, saying the possible side effect occurred in the UK. 

READ: COVID-19 Vaccine: Serum Institute Gets DCGI Nod To Resume Phase Two, Three Trials

AstraZeneca's vaccine named AZD1222 was previously dubbed by the WHO as the frontrunner and one at the most advanced stage of clinical trials. Last week, the company announced that its standard review process had triggered a pause to vaccination to allow the review of safety data. However, the company did not share any more information about the possible side-effect rather than just calling it 'a potentially unexplained illness'. 

Temporary holds on the large studies of vaccine trials are very common. Also, it is mandatory for the company to investigate all the serious and unexpected reactions of the candidate to ensure safe testing trials. Address questions regarding the pause on the vaccine trials, AstraZeneca said that maybe this illness could be a coincidence as the illness of all sorts are possible to arise in such vaccine trial studies. 

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