Squeezing the total time from earlier estimates of around 15-18 months to recently declared one month is the main bone of contention according to the health experts.
Covaxin launch to be launched on August 15? The sudden announcement made by Indian Council of Medical Research (ICMR) regarding the public launch of the Covid-19 vaccine by August 15 has given a ray of hope to people but also triggered concerns with health professionals. They have raised questions over the possibility of the quick launch of the vaccine. The cause of bewilderment for the health experts is the fact that even the first stage of human trials has not been commenced in the country. Also, the world pharma leaders leading the race to produce the vaccine are also aiming at the public launch of the vaccine not before the fag end of the year, despite having started the third phase of human trials.
Dr Balram Bhargava, head of the ICMR has written to all the twelve sites involved in the development of the vaccine to wrap up all the clinical trials by August 15. The company which is leading the development of the vaccine Bharat Biotech India Limited (BBIL), which had earlier planned to complete the enrolment of the trials by July 13 will also have to prepone its schedule as per the announcement made by ICMR and conclude the enrolment of trials by July 7, according to an IE report. The company in its application submitted to the Clinical Trials Registry of India (CTRI) has cited the date July 13 for the completion of the enrolment of the trials.
Typically the development of any vaccine has to pass three phases of human trials. According to the information provided by CTRI, BBIL had in its application estimated that the first and second phases of human trials would alone take more than 15 months while the first phase was expected to take a month, according to the IE report. Squeezing the total time from earlier estimates of around 15-18 months to recently declared one month is the main bone of contention according to the health experts.
Even the most advanced companies which are in their advanced phase have a longer time frame, Dr Anant Bhan, Researcher, Global Health, Bioethics and Health Policy told IE. The announcement raises several questions and it would be very surprising if it is done, he added. Dr Shashank Joshi, Dean of the Indian College of Physicians also concurred and told IE that the development of the vaccine should not be hurried at the cost of efficacy and safety.
Some experts acknowledged that there are ways by which the vaccine trials could be fast-tracked but even then it takes at least a year to complete the process. If the data from the first two phases of the human trials is compelling enough then the third phase could be curtailed and emergency use approval given, another expert on the condition of anonymity told IE.