July 3, 2020 / 8:15 AM / a month ago

Short timeline for India vaccine test raises doubts among health experts

NEW DELHI/BENGALURU, July 3 (Reuters) - The chief of India’s top clinical research agency said in a leaked letter circulated on Friday it envisaged launching a novel coronavirus vaccine by Aug. 15, prompting derision from some health experts who questioned the timeline.

Dozens of vaccine candidates are at various stages of development around the world to control the coronavirus pandemic.

One candidate, from India’s Bharat Biotech, which is being developed with the Indian Council of Medical Research, was this week approved for Phase I and Phase II clinical trials.

“It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of all clinical trials,” ICMR Director General Balram Bhargava said in the letter, dated July 2 and addressed to institutions involved in the trials.

Phase I and Phase II trials typically test the safety of a drug before it enters Phase III trials that test its efficacy.

Each phase can last months, if not years, but regulators globally have been fast-tracking trials on medicines and vaccines aimed at tackling the cornavirus, which has infected more than 10.89 million people globally and killed more than 520,066​, according to a Reuters tally.

The Indian vaccine project was being monitored “at the topmost level of the government”, Bhargava said in the letter, which was widely circulated on social media.

A Bharat Biotech spokesman declined to comment but an ICMR official, who asked not to be identified, said the letter was a private communication and was being misinterpreted.

Anant Bhan, a doctor and public health researcher, questioned the speed of the trial suggested in the letter and asked if its efficacy was being decided in advance.

“To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries,” Bhan said on Twitter.

“Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process.”

Several other health experts also questioned the proposed launch date of the vaccine.

The ICMR official said the aim was to complete all trials on the vaccine candidate by Aug. 15. He did not say exactly when he thought the vaccine might be launched for public use.

“The letter is something and interpretation is something (else),” the official said. (Reporting by Sachin Ravikumar and Devjyot Ghoshal; Writing by Zeba Siddiqui Editing by Euan Rocha, Robert Birsel)

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