New Delhi|Ekta
As experts cautioned against rushing the process for developing a COVID-19 vaccine after the ICMR stated it plans to launch it by August 15, the apex health research body on Saturday clarified that it is acting in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.
In ICMR in its clarification said that the letter by director general of ICMR Balram Bhargava to principal investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.
However, the clarification letter has no mention of either the proposed launch date or start of the trial date.
All other vaccine candidates across the globe have been similarly fast-tracked, it said, adding that the Drugs Controller General of India (DCGI) has accorded permission to conduct phase 1 and 2 (human) clinical trial of ‘Covaxin’ based on in-depth scrutiny of the available data from pre-clinical studies.
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.
“The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay,” the ICMR said in a statement.
After intense characterization and review of all data from BBIL, the ICMR said that it is supporting the clinical development as the vaccine candidate appears to be promising.
In the larger public health interest, it is important for the ICMR to expedite the clinical trials with a promising indigenous vaccine, the statement stated.
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, it said.
“The 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,” it said.
Meanwhile, scientists on Saturday red-flagged the issues like vaccine’s safety and efficacy would be compromised when a vaccine’s trial is fast-tracked in just four weeks of time.
Expressing his concern over the ‘sudden’ launch of a vaccine, Director of CSIR-Centre for Cellular and Molecular Biology (CCMB) Rakesh K Mishra said, “A vaccine for COVID-19 cannot be expected before early next year as the process involves a lot of clinical trials and data testing.”
“If everything goes absolutely really like a textbook plan, then we are talking about six to eight months to think of something that now we have a vaccine as you have to test in large numbers,” he said.
On the issue, virologist Upasana Ray said that an accelerated launch or promise for launch of a vaccine against the coronavirus deserves applause but it is important to ask whether we are rushing too much.
“We must rush albeit carefully. Giving this project high priority is absolutely important. However, excess pressure might not necessarily lead to a positive product for public use,” said Ray, who is the senior scientist at CSIR-IICB, Kolkata.
As per noted experts, vaccine development is a multi-phase process. Phase 1 trials are small-scale, usually involving a few participants, to assess whether the vaccine is safe for humans. Phase 2 trials often involve several hundred subjects and mainly evaluate the efficacy.
The final phase involves thousands of people to further assess the efficacy of the vaccine over a defined period of time, and can last several months.
In another development, Serum Institute of India (SII) CEO Adar Poonawalla has claimed that the Covid-19 vaccine being developed at the University of Oxford will hit the market by the year-end.
