Indian Council of Medical Research (ICMR) had issued a memo on July 2 and has set a target date of August 15 to develop a coronavirus vaccine this created a backslash from both medical experts and the opposition.
Giving a reply to all the criticism ICMR in their press release said that “ICMR process to develop a vaccine to fight COVID 19 pandemic as per globally accepted norms of fast-tracking. Safety and interest of people are the topmost priority”.
“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” reads the press release.
Now that preclinical studies have been completed successfully, the phases 1 and 2 human trials are to be initiated. The letter by 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.
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.
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 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.
Though a large number of vaccines are under various stages of development all across the world, it is also important to promote indigenous vaccine development while at the same time ensuring safety, quality, ethics, and adherence to all regulatory requirements.