In Haryana, Post Graduate Institute of Medical Sciences in Rohtak will go for clinical trial of Covaxin vaccine prepared by Bharat Biotech for Novel Corona virus in coordination with Indian Council of Medical Research and National Institute of Virology.The other trial sites included are AIIMS, New Delhi, AIIMS, Patna and SRM Medical College Hospital and Research Centre in Tamil Nadu

The Government of India has granted permission to 13 medical institutes in the country including PGIMS, Rohtak after successful clinical trial on animals. Giving this information, the Vice Chancellor of Health University, Rohtak Dr. O. P. Kalra said that the clinical trial will be done on 375 persons in the first phase and on 750 persons in the second phase. He said that the registration for it will start next week.

Dr Kalra said that this is first vaccine prepared in India, for which permission of clinical trial has been given. He said that Professor of Pharmacology Department Dr Savita Verma have been given the responsibility of Principal Investigator for the trial of vaccine, while State Nodal Officer for COVID-19 Dr Dhruv Chaudhary and and Dr Ramesh Verma of Community Medicine Department will be the investigator in her team.

Dr Kalra said, the trial would be done on healthy persons with no morbidity and the effect of vaccine would be observed firstly after one week and second time after 28 days. He said that the full data base of the trial would be prepared by the institute.Meanwhile,  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.” Also Read - After India's Ban, TikTok Predicts Over USD 6 Billion Loss, Says Report

“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.

With Inputs from ; India.com