US FDA willing to allow use of its COVID-19 vaccine candidate before clinical trials end

Triggering fresh waves of concerns, head of US Food and Drug Administration (FDA) indicated that he might allow the usage of America’s COVID-19 vaccine candidate before the traditional clinical trials are concluded. While the coronavirus outbreak has continued to tighten its grip across the world and the US remains the most virus-hit country in the world with over 6 million infections, the desperation to derive a suitable vaccine has only grown more intense. 

However, while the global research of COVID-19 vaccine is still ongoing, the US FDA commissioner Stephen Hahn told the Financial Times in an interview published recently that he was prepared to issue emergency use authorisation for COVID-19 vaccine before the end of the final stage of human trials that are aimed at stringent testing of drug’s safety and efficacy. Hahn claimed that the standard he has applied would be “that the benefit outweighs the risk” in a public health emergency.

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Reaffirming his stance on the issue, the US FDA Commissioner also mentioned that his decision will not be influenced by the political pressure amid the tense atmosphere of upcoming presidential elections in the US. Stahn said that the COVID-19 vaccine research will be dominated by science, medicine and data and not politics. However, his statements reportedly sparked concerns among the public health experts about the apparent willingness to consider fast-tracking vaccine over the standard testing process. 

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AstraZeneca begins final stage trial

Meanwhile, UK’s AstraZeneca has begun the final large-scale human trial of its COVID-19 vaccine in the US, the company said in a statement. The British pharmaceutical giant plans to enrol as many as 30,000 adults at 80 sites in the US to test the shot that has shown promising results in the previous trials. This phase 3 trial is being implemented as part of Operation Warp Speed in the US, which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.

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Image: PTI