Covid-19 vaccine: No necessary process will be skipped, says ICMR

ICMR said on Friday it was attempting to launch the world’s first Covid-19 vaccine on August 15, triggering disbelief in the scientific community.

The Indian Council of Medical Research (ICMR) said on Saturday that its attempt to speed up the development of a potential coronavirus disease (Covid-19) vaccine was aimed at cutting red tape, a remark that came after its plan of a mid-August launch invited condemnation from experts for setting an impractical target not in line with rigorous scientific standards.

Globally, 18 experimental Covid-19 vaccines are in various phases of human trials.(Vipin Kumar/HT file photo)

Experts said the premier biomedical research body’s clarification on Saturday that the move was meant to cut red tape did not address how the accelerated timeline could be achieved. The timeline appeared unrealistic even by the best global standards and involved potential risks, they said.

ICMR said on Friday it was attempting to launch the world’s first Covid-19 vaccine on August 15, triggering disbelief in the scientific community. The plan was disclosed in a letter by ICMR to 12 institutes where human trials are to be held for the vaccine, Covaxin, ordering them to secure necessary approvals from internal committees and recruit people for clinical tests by July 7 with a warning that “non-compliance will be viewed very seriously”.

The vaccine has been jointly developed by ICMR and Hyderabad-based Bharat Biotech (BBIL), with the latter itself previously indicating that a vaccine could take more time. In a report on Wednesday, Bharat Biotech chairman and managing director Krishna Ella said that if clinical trials of Covaxin met safety and efficacy standards, the vaccine could be available for mass use by early 2021.

On Saturday, ICMR said: “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... ICMR is committed to treat the safety and interest of people of India as a topmost priority.” This statement mentioned neither the August 15 deadline, nor the July 7 one .

The statement followed widespread condemnation for ICMR for appearing to abandon clinical trial safeguards and putting the lives and safety of people at risk in its rush to produce an indigenous vaccine by Independence Day, a feat that is impossible if scientific protocols for trial and data review are followed.

In the letter, dated July 2, ICMR director general Dr Balram Bhargava said that the first indigenous vaccine being developed by India was one of “the top priority projects which is being monitored at the topmost level of the Government”.

“ln view of the public health emergency due to Covid-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than 7 July 2020. Kindly note that non-compliance will be viewed very seriously,” said the ICMR-DG.

In the statement issued on Saturday, the apex research organisation said: “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.”

“Our trials will be done following the best practices and rigour, and will be reviewed, as required, by a Data Safety Monitoring Board (DSMB)... ICMR is committed to treat the safety and interest of people of India as a topmost priority,” it said.

Bharat Biotech chairman Krishna Ella, who was copied on Dr Bhargava’s letter, declined to comment on ICMR’s timeline of clinical trials, but said previously that if clinical trials of Covaxin were successful, the vaccine would be ready for mass use by early 2021. Bharat Biotech is among seven Indian firms working on Covid-19 vaccines and was the first to get the regulatory nod to begin Phase 1 and Phase 2 human trials on Monday to test the vaccine for efficacy and safety.

“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 ICMR statement said.

Trials for vaccines can take several years. Several countries have allowed the development processes to be fast-tracked to tackle the unprecedented health emergency but even the leading efforts are estimated to conclude the development process only by the end of the year.

Clinical trials involve inoculating people with an experimental vaccine to test whether it is safe and effective, a process that, on average, takes at least 10 years.

Experts say ICMR’s timeline for Covaxin is scientifically implausible even by the global fast-tracked standards, as the vaccine is yet to begin human clinical trials. Globally, 18 experimental Covid-19 vaccines are in various phases of human trials.

“There is no sensible scientific way that makes it possible to announce that a potential vaccine will be ready without three months of phases 1 and 2 trial data to indicate whether it will work at all. Even with fast-tracking and planning phase 3 trial in anticipation of the first two phases being successful, the trial can begin only after data from the first two trials is analysed and certified, which takes at least three months. You need at least six months for preliminary data on how effective and safe the vaccine is; how can you do it in six weeks?” asked Dr T Jacob John, virologist and former professor at the Christian Medical College, Vellore, Tamil Nadu.

A researcher, who works with the government and did not wish to be named, said: “Never ever has such an end timeline to develop a vaccine or drug been given for a new antigen. Science depends on clinical outcomes; it doesn’t follow deadlines. The definitive language in the letter is problematic.”

ICMR’s Saturday letter had a response to such criticism too.

“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.”

Dr Bhargava did not respond to repeated calls and text messages seeking comment.