Indian Council of Medical Research (ICMR) has released a statement defending its target to launch a vaccine by August 15, 2020. It declared, “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 the 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.”
It informed that the letter by Dr Balram Bhargava, DG-ICMR to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants. It stated, “Just as red tape was not allowed to become a hindrance in the fast track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement. The aim is to complete these phases at the earliest so that population-based trials for efficacy could be initiated without delay.”
ICMR’s statement also said, “Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB). While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of 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.”
The statement comes in the wake of fears, scepticism and criticism over the August 15 deadline for the launch of the COVID-19 vaccine, which is being developed in collaboration between, Bharat Biotech and ICMR-NIV. Many experts from the scientific community have cautioned that hasty measures could impair the efficacy and safety of the vaccine and hurt India’s credibility.