Published 19:18 IST, July 4th 2020
ICMR assures 'commitment to safety' as scientists question deadline for Covaxin launch
ICMR, on Saturday issued a press release assuring that they are committed to treating public safety as the topmost priority, amid the debate over rushed vaccine
Amid the debate over 'rushed vaccine trials', Indian Council of Medical Research (ICMR), on Saturday issued a press release assuring that they are committed to treating public safety as the topmost priority. Explaining that Bharat Biotech International ltd's (BBIL) vaccine appears to be promising, ICMR is expediting clinical trials (phases 1 and 2), as allowed by Drugs Controller General of India. Moreover, ICMR said that the process followed by the apex medical body is in 'accordance with the globally accepted norms to fast-track vaccine development'. India currently has 6,48,315 COVID-19 cases, of which 2,35,433 are active, 3,94,227 have recovered while 18,655 have succumbed to the pandemic.
ICMR assures safety in fast-tracking Covaxin
Clarifying that the stern letter issued by ICMR to 12 institutes to expedite clinical trials was meant to cut 'unnecessary red tape'. Likening the process to the approval of new indigenous testing kits, ICMR stated that it aims to complete these two phases at the earliest so that population-based trials for efficacy could be initiated without delay. Pointing out that ICMR's practices will be reviewed by a Data Safety Monitoring Board (DSMB), ICMR asked critics to not second guess its professionalism or adherence to the highest scientific rigour.
ICMR fast-tracks Covaxin trials
On Friday, ICMR fast-tracked BBIL's Coronavirus (COVID-19) vaccine - Covaxin's clinical trials. In an official statement, ICMR Director General Balram Bhargava stated that ICMR aims to launch the indigenous COVID-19 vaccine by August 15. Covaxin was approved by the DCGI recently to proceed to clinical trials after it showed promise in its pre-clinical data.
The country's apex medical body has selected 12 institutes across the country and has advised them to expedite approvals and complete recruiting for the trials by 7 July. "Kindly note that non-compliance will be viewed seriously," the letter states, adding that the institutions must treat this project on the highest priority and meet the given timelines without any lapse. Reports state that seven of the 12 institutes are medical colleges or government hospitals - including AIIMS-Delhi, SUM Hospital, Jajapur (Odisha), Gillurkar Multispecialty Hospital in Nagpur etc.
Reacting to the ICMR letter, several experts had raised fears that its safety and efficacy could be compromised. Moreover, scientists have disapproved the strict and 'nearly impossible' timeline set by ICMR with an aim to launch the vaccine by August 15. Scientists have also questioned the feasibility of mass production of the vaccine if desired results are achieved.
What is Covaxin?
Aa per BBIL website, Covaxin is an indigenous COVID-19 vaccine by Bharat Biotech, developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). Covaxin is an “inactivated” vaccine developed from eliminated COVID-19 virus particles. Injecting the 'inactivated' virus particles helps in creating antibodies against the dead virus, according to BBIL.
Updated 19:18 IST, July 4th 2020