A letter from Dr Balram Bhargava of India’s ICMR informed that it envisaged launching a novel coronavirus vaccine by August 15. This has prompted scepticism from some health experts who questioned the short timeline.
“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,” Anant Bhan, a doctor and public health researcher, said on Twitter.
“Even with accelerated timelines, this seems rushed, and hence with potential risks, inadequate attention to the process.” Several other health experts also questioned the launch date proposed in the letter, which was widely shared on social media.
The COVID-19 vaccine being developed by Bharat Biotech and Indian Council of Medical Research (ICMR), was approved for Phase I and Phase II clinical trials early this week. 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, and although regulators globally have been fast-tracking trials on medicines and vaccines to treat the novel coronavirus, the timeline envisaged in the letter would be unprecedented.
An ICMR official, who asked not to be identified, said the letter was a private communication and was being misinterpreted. The official said the aim was to complete all trials on the vaccine candidate by August 15 and did not say when he thought it might be launched for public use.
In an emailed statement to Reuters, Bharat Biotech’s Managing Director Krishna Ella said the company had a target to produce up to 300 million doses of the vaccine per year if it succeeds in clinical trials.
“Enrollment of the cohort for the phase I is underway,” Ella said, adding the company was awaiting approvals for human clinical trial vaccine batches from the Indian regulator.