New Delhi: Facing criticism from health experts for asking scientists to speed up human trials of indigenous COVID-19 vaccine and complete it by August 15, the ICMR on Saturday said its process is in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.
In a statement, the ICMR said that the letter by DG Dr Balram Bhargawa was intended to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest. It added that since pre-clinical studies have completed successfully now, the phases 1 and 2 human trials are to be initiated.
“In the larger public health interest, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine. Faced with the unprecedented nature of the COVID-19 pandemic and the consequent dislocation of normal life, all other vaccine candidates across the globe have been similarly fast-tracked. ICMR’s 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,” ICMR said.
The ICMR said its trials will be done following the best practices and rigour, and will be reviewed by a Data Safety Monitoring Board (DSMB).
“While issues raised in the public domain from time-to-time by commentators are welcome, as they form an important part of the feedback loop, the best of India’s medical professionals and research scientists should not be second guessed for their professionalism or adherence to the highest scientific rigour. ICMR is committed to treat the safety and interest of people of India as a topmost priority,” the statement said.