ICMR assures 'commitment to safety' as scientists question deadline for Covaxin launch

Amid debate over 'rushed vaccine trials', Indian Council of Medical Research (ICMR), on Saturday issued a press release assuring that y are committed to treating public safety as 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 process followed by apex medical body is in 'accordance with globally accepted rms 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 pandemic. 

ICMR fast-tracks Bharat Biotech's 'Covaxin' Covid vaccine; enviss launch by August 15

ICMR assures safety in fast-tracking Covaxin

Clarifying that stern letter issued by ICMR to 12 institutes to expedite clinical trials was meant to cut 'unnecessary red tape'. Likening process to approval of new indigeus testing kits, ICMR stated that it aims to complete se two phases at 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 t second guess its professionalism or adherence to highest scientific rigour.

Assam to revise COVID-19 testing pattern after ICMR advice; plasma rapy to start soon

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 indigeus COVID-19 vaccine by August 15. Covaxin was approved by DCGI recently to proceed to clinical trials after it showed promise in its pre-clinical data.

country's apex medical body has selected 12 institutes across country and has advised m to expedite approvals and complete recruiting for trials by 7 July. "Kindly te that n-compliance will be viewed seriously," letter states, adding that institutions must treat this project on highest priority and meet given timelines without any lapse. Reports state that seven of 12 institutes are medical colleges or government hospitals - including AIIMS-Delhi, SUM Hospital, Jajapur (Odisha),  Gillurkar Multispecialty Hospital in Nagpur etc.

Reacting to ICMR letter, several experts had raised fears that its safety and efficacy could be compromised. Moreover, scientists have disapproved strict and 'nearly impossible' timeline set by ICMR with an aim to launch vaccine by August 15. Scientists have also questioned feasibility of mass production of vaccine if desired results are achieved.

What is Covaxin?

Aa per BBIL website, Covaxin is an indigeus COVID-19 vaccine by Bharat Biotech, developed in collaboration with Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). Covaxin is an  “inactivated” vaccine developed from eliminated COVID-19 virus particles. Injecting 'inactivated' virus particles helps in creating antibodies against dead virus, according to BBIL.