ICMR defends August 15 Covid vaccine deadline, says process ‘as per global norms’

The official claim by the ICMR that it envisaged the “launch” of the vaccine for “public health use latest by August 15” has sparked fears that its safety and efficacy could be compromised to meet the timeline. The August 15 timeline is mentioned in a letter that ICMR director general Balram Bhargava wrote to the 12 hospitals selected for carrying out clinical trials of Covaxin, a candidate vaccine developed by Bharat Biotech, a Hyderabad-based pharmaceutical company, in partnership with Pune-based National Institute of Virology, an ICMR laboratory.

Stating that the issues raised in the public domain by commentators are welcome, the ICMR further said, “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 said it is committed to treat the safety and interest of people of India as a topmost priority.

“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,” ICMR statement added.

“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,” the ICMR said, adding that “the aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.”

“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,” it said.

A vaccine usually goes through three phases of human trials. The Central Drugs Standard Control Organisation has given approvals for phase I and II trials so far. According to details from Clinical Trials Registry of India (CTRI), the Bharat Biotech India (BBIL) in its application estimated phase I and II trials to take a year and three months, including at least a month for phase I alone. Experts have questioned how all three phases can be concluded within a month and a half.

Even AIIMS Director Randeep Guleria, the head of the clinical research group of the national task force on COVID-19, called it a “very challenging and difficult task.” “Also, if we get the desired results, the other challenge is the process of mass production of the vaccine,” he said.

While the vaccine trials can be fast-tracked, it still takes over a year to launch the product, experts said.