US FDA investigating AstraZeneca's COVID-19 vaccine trial, says chief

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

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

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AstraZeneca pauses trial 

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

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

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

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