The clarification from the government’s apex medical research body comes in the wake of concerns in the medical and scientific community for ICMR setting August 15 as a target for developing a coronavirus vaccine and asking clinical trial investigators to enrol participants by July 7.
The letter was written by ICMR director general Dr Balram Bhargava. While timelines were strongly questioned by the scientific community, ICMR said the effort was to speed up recruitment for human trials and “process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel”.
Amar Jesani, editor of Indian Journal of Medical Ethics and a public health advocate, said,“Firstly, I wish today’s ICMR statement was signed by its DG because it was his letter to investigators of the vaccine that created the storm. Most of the issues raised in that letter still remain hanging without any answer. ICMR is silent on the timeline, the statement does not mention August 15. How have they arrived at this date? Do they plan to waive off Phase 3 trials? The DG must also apologise for threatening the institutions, ethics committee and the scientific community by saying that not adhering to timeline will attract action.”
Anant Bhan, researcher on biotech and ethics said, “It is good to see ICMR clarify its intent to conduct the trial scientifically. However, the concerns raised with regards to the timelines, the instructions to the sites to comply have not been clarified, including on the ethical red flags these raise.”