The Indian Council of Medical Research (ICMR) has issued a clarification following criticism over its claim of plan to release a Coronavirus vaccine by 15 August while starting human trials for the same in July. ICMR has said that while it aims to expedite clinical trials of COVAXIN, developed in collaboration with Bharat Biotech, all globally accepted norms for vaccine development will be followed. ICMR has clarified that it has asked the clinical study sites only to cut red tape related to the trial for the Coronavirus vaccine, and not to bypass any clinically necessary step.
On July 3, ICMR’s letter to 12 medical intuitions selected for human trial of the vaccine had appeared in media. In the letter, the medical body had asked the institutions to expedite the process and complete the enrolment by subjects by July 7, so that the vaccine can be released to the public by August 15. Mention of this date had created a controversy, as many believed that it is too early for a trial which has not started yet. Several media houses had reported that scientists are troubled by this deadline set by ICMR, and questioned the entire process of developing a vaccine for Coronavirus in India. Media had reported researchers and virologists quoting that completing the trial in such a short period is not possible, and advising ICMR to be careful.
After the growing criticism over particularly the deadline, ICMR in a statement issued on July 4 has clarified that it has asked the study sites chosen for the trial to cut red tape to complete the trial as soon as possible. The medical body also said that all other Coronavirus vaccine development efforts across the globe have been fats-tracked in the similar manner. ICMR has confirmed that it has tried to ensure that the vaccine is not stuck in files, and also will conduct multiple steps in the development process simultaneously, like human and animal trials.
“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”, the statement says.
ICMR informs that the pre-clinical studies on COVAXIN have been completed successfully, and now phase 1 and 2 human trains for the same will start.
“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”, ICMR adds.
In phase 1 of a clinical trial, a drug under development is tested on small number of healthy volunteers to check its safety, while in phase 2, it is tested on a small number of patients of the disease to check its efficacy. After both the phases, phase 3 is conducted on a larger number of patients to determine its efficacy level
The Country’s apex body on medical research confirmed that the “trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB)”.
They also slammed the media reports for questioning the efforts to develop the virus by saying that “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.” ICMR also confirmed that it is committed to treat the safety and interest of people of India as a topmost priority.