New Delhi: Amid doubts over ICMR’s claim to launch the COVID-19 vaccine by August 15, the Indian Council of Medical Research has written to the hospitals selected for a clinical trial of the vaccine to not delay the process. “Non-compliance will be viewed very seriously,” ICMR Director-General Dr Balram Bhargava wrote in his letter.

Mentioning that this is one of the top priority projects, the ICMR chief wrote, “Covaxin is being monitored at the top-most level of the government.”

The trial sites included AIIMS, New Delhi, AIIMS, Patna and SRM Medical College Hospital and Research Centre in Tamil Nadu.

“It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” Bhargava said in the letter.

“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.”

COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the DCGI.

Separately, Zydus, which is part of Cadila Healthcare Ltd., said in a statement on Friday that it has received approval from authorities to start human trials for its COVID-19 vaccine contender.

However, it is not clear how the clinical trials can be completed and the vaccine released on August 15 when the normal period for a vaccine to be approved is 12 to 18 months. Many experts said it is impossible to start clinical trial recruitment on July 7 as its pre-clinical development is still ongoing. Also, how the efficacy of it can be decided within a month is being questioned.

What is COVAXIN?

Covaxin is a vaccine candidate that was developed by BBIL in collaboration with the National Institute of Virology (NIV) for the treatment of highly infectious and deadly disease COVID-19.