Top Medical Body ICMR Gives Clarification Over August 15 COVID-19 Vaccine Deadline

NEW DELHI: A day after facing criticism over the Indian Council of Medical Research's (ICMR) decision to fast-track India’s first vaccine candidate for Covid-19 and set a deadline for August 15, the ICMR on Saturday said the process is "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”. COVAXIN was developed by Hyderabad based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

ICMR said that the letter sent by its Director General Dr Balram Bhargava to the investigators of the clinical trial sites was meant to cut unnecessary red tape without bypassing any necessary process, and speed up recruitment of participants. The launch of novel coronavirus vaccine by Independence Day sparked fears that its safety and efficacy could be compromised and also gave rise to accusations by the opposition that the date was set only to help Modi's government.

ICMR in its statement said that, "Just as red tape was not allowed to become a hindrance in the fast-track approval of new indigenous testing kits or to the introduction of related Covid-19 drugs in the Indian market, the indigenous vaccine development process was also sought to be insulated from slow file movement." The main of ICMR is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.

ICMR further added 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 is committed to treat the safety and interest of people of India as a topmost priority."

After a vaccine undergoing three phases of human research it will be released into the market. The Central Drugs Quality Control Organization has so far given approvals for Phase I and Phase II trials. According to the reports from the Indian Clinical Trials Registry (CTRI), the Bharat Biotech India (BBIL) said that estimated phase I and phase II trials will take at least one year and three months, including at least one month for phase I alone. Experts wondered how all three stages could be completed within a month and a half. AIIMS Director Randeep Guleria, the head of the Clinical Research Group of the National Task Force on COVID-19, called it as unrealistic and difficult task. He further added that, "Even if we get the best results, the next challenge is the method of mass development of the vaccine."