The Indian Council of Medical Research (ICMR), on Wednesday, wrote to 12 hospitals, including the All India Institute of Medical Sciences (AIIMS), Delhi, to fast-track clinical trial of the Covid-19 vaccine candidate BBV152, developed by Bharat Biotech International Limited
The Indian Council of Medical Research (ICMR), on Wednesday, wrote to 12 hospitals, including the All India Institute of Medical Sciences (AIIMS), Delhi, to fast-track clinical trial of the Covid-19 vaccine candidate BBV152, developed by Bharat Biotech International Limited, a Hyderabad-based vaccine manufacturer. ICMR has set a deadline of July 7 for recruitment for the trial, stating that a launch for public health use is being targeted by August 15.
ICMR envisages a 5-6 week period for the completion of the trial of Covaxin (the vaccine candidate’s brand name). This is a significantly shorter timer-frame from WHO’s projection that a vaccine may only be available in the next 12-18 months. “At the moment, we don’t have a proven vaccine, but if we are lucky there will be one or two successful candidates before the end of this year,” WHO’s chief scientist Soumya Swaminathan had recently said in a virtual conference.
Covid 19 vaccine developers AstraZeneca, which is working with the University of Oxford, is already in Phase 3 of human trial — where a drug/vaccine is observed for therapeutic effect and adverse effects over a longer period than the previous phases — for its vaccine candidate.
US-based Moderna (in collaboration with federal research institutions) last month started Phase 2 trials for its candidate. Clinical trials for both candidates had started in late-March/April this year. Both developers have announced that their products could hit the market in the last quarter of this year. When Moderna had announced its trial in March, it had spoken of a two-dose schedule 28 days apart, with the vaccine’s efficacy and safety observed over 12 months from the second dose. Even with regulatory easing, the vaccine would take 7-8 months from the commencement of trial to hit the market.
Bharat Biotech’s application with the Clinical Trial Registry of India (CTRI) shows that it will be conducting Phase 1 and 2 trials involving 1,125 participants over 30 days. As of Thursday, the CTRI website showed that the trial had received ethics committee approval from six of the 12 hospitals.
ICMR has warned the hospitals where the trials will be conducted that the vaccine is one of the “top priority projects which is being monitored at the topmost level of the government”, and “non-compliance will be viewed very seriously”.