Covid-19 vaccine: After Trump’s ‘vaccine before polls’ remark, U.S health experts caution drug regulator FDA

The letter written by the top American virologists, epidemiologists, and vaccinologists, however, has no mention of the President’s remarks.

A group of 400 top medical experts in US have written to the Food and Drug Administration (FDA) asking it to ensure that the Covid-19 vaccine is approved only after the completion of due clinical process and remains devoid of any political considerations. The development comes days after U.S President Donald Trump who is seeking re-election at the end of the year had said that the vaccine would be ready before the polls that begin on November 3, according to an Indian Express report.

Further fueling the concerns, Trump said that the arrival of the vaccine before the polls “won’t hurt” when he was asked if his prospects would improve with the early development of the vaccine. He later clarified that he wanted a vaccine early in order to save the lives of many people. The letter written by the top American virologists, epidemiologists, and vaccinologists, however, has no mention of the President’s remarks.

According to the content of the letter, the experts underscored the need of a vaccine fast but added that all the vaccine candidates must be rigorously studied to determine whether their benefits scored over their risks. The letter further urged the FDA to evaluate the safety and efficacy of the potential vaccine from the completed data of phase 3 completed clinical trials. Among the undersigned in the letter are a former surgeon general of the US and a former head of the FDA along with a host of health experts.

Stressing on the fact that the evaluation and rigorous examination of the vaccine must be devoid of any political considerations, the letter said that all information about the potential vaccine must be explained to the public. With the development of the vaccine going at a frantic pace, concerns have been raised by health experts over the possibility of giving short shrift to health and clinical procedure.

Anthony Fauci, the top infectious diseases expert in the United States had also recently said that he had been assured by FDA that safety and efficacy would remain the prime consideration. He also added that he was optimistic that the vaccine would be on the horizon by early next year. Similar concerns had been raised in India after a letter from the ICMR had set the deadline of August 15 for the release of the Covid-19 vaccine which has been developed by Hyderabad-based Bharat Biotech and currently under phase 2 clinical trials.