India’s apex medical body ICMR said Friday that it aims to launch the world’s first COVID-19 vaccine, the indigenously developed Covaxin, by August 15, and has told select medical institutions to fast-track its clinical trial approvals. But experts said such a timeline may not be realistic.
The Indian Council of Medical Research(ICMR) has identified 12 clinical trial sites, including medical institutions and hospitals, and has asked their principal investigators to ensure that the subject enrolment is initiated no later than July 7. The trial sites included AIIMS, New Delhi, AIIMS, Patna and SRM Medical College Hospital and Research Centre in Tamil Nadu.
COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech International Limited(BBIL) in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drug Controller General of India(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.
The vaccine candidate, ZyCoV-D, showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus said.
In its letter to principal investigators of the 12 sites, ICMR Director General Dr Balram Bhargava noted that the clinical trial of Covaxin is one of the “top priority projects which is being monitored at the top-most level of the government”.
“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, final outcome will depend on the cooperation of all clinical trial sites involved in this project,” Bhargava said in the letter. 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.