The Indian Council of Medical Research’s (ICMR) announcement that the COVID-19 vaccine will be available for use by August 15 has drawn sharp criticism. Experts say that the deadline violates the timeline needed to conduct human trials and other measures before the vaccine can be ready for use.
The vaccine that has received permission for clinical trials is COVAXIN, developed by Bharat Biotech, in association with Pune-based National Institute of Virology, which comes under the ICMR. The August 15 deadline mentioned in a letter that ICMR Director General Balram Bhargava wrote to the 12 hospitals selected for carrying out clinical trials of COVAXIN is what has caused a furore.
“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 July 7, 2020,” Bhargava said in the letter. He also warned that higher authorities are monitoring the process, and ‘non-compliance will be viewed very seriously’. “You are advised to treat this project on highest priority and meet the given timelines without any lapse,” he stated in the letter.
ICMR spokesperson Rajinikanth Srivastava also confirmed that the ICMR has made a request to ‘fast-track’ the vaccine trials. The 12 hospitals selected for clinical trials include Delhi AIIMS and Patna AIIMS.
Ahmedabad-based pharmaceutical company Zydus Cadila has also received permission for human trials of its COVID-19 vaccine contender. The pre-clinical trials of the company’s ZyCov-D were successful, and the company hopes to finish clinical trials in three months.
