COVID-19 Vaccine Update: Amid the hue and cry over ICMR setting up a near-impossible target of August 15 for a Coronavirus vaccine jointly developed by ICMR and Bharat Biotech, reports claimed that government officials told the parliamentary standing committee on science and technology on Friday that a vaccine is not possible till next year.Also Read - Omicron: South Korea Expands Entry Ban to 2 More African Countries From Dec 10
The ICMR identified 12 clinical trial sites, including medical institutions and hospitals, and has asked their principal investigators to ensure that the subject enrolment is initiated no later than July 7. Also Read - Omiron Scare: Maharashtra Reports 10 Fresh Cases of New Variant, State's Total Tally Touches 20
In a letter to medical institutions, ICMR director-general Balram Bhargava wrote, “It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials…. Also Read - Tips on How to Keep Viral And Other Infections at Bay Amidst the Changing Weather
“You have been chosen as a clinical trial site of the BBV152 COVID vaccine. In 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 the initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7,” the letter stated.
After medical experts cautioned against rushing a COVID-19 vaccine, the ICMR on Saturday defended its move to fast-track clinical trials for a planned launch by August 15, saying the process was exactly in accordance with globally accepted norms.
The premier medical research body said the letter by its Bhargava was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.
Trials will be done following the best practices and rigour, the Indian Council for Medical Research(ICMR) said in a statement, seeking to address concerns voiced by several experts who said the timeline set by the research body may not be realistic.
India’s COVID-19 vaccine candidates will go through a rigorous evaluation process that will not be compromised, the government’s Principal Scientific Advisor K VijayRaghavan has said.
Phase 1 of the human trial of any vaccine usually takes 28 days and that is followed by two other phases, Vijay Raghavan said.
“Today is 10th of the July and let’s say the phase 1 trial starts today. And they start at all the 12 sites simultaneously…(which is) unlikely.
Let us assume that they start together. Phase 1 trial involves an injection, then another injection after seven days and then an examination after 14 days and then looking at the results of that before deciding, so after 28 days..” Raghavan said.
After Phase 1, there are two other phases.