Indian Council of Medical Research (ICMR) head Dr Balram Bhargava on July 2 wrote to all 12 trial sites for the Covid-19 vaccine candidate, Covaxin, that all clinical trials had to be completed by August 15, in time for a public launch. Bioethics experts, however, have questioned how all three phases of testing for a vaccine candidate yet to even begin human trials can be crunched into a timeframe of a month.
Is ICMR serious? The August 15 deadline given by the Indian Council of Medical Research (ICMR) for the launch of the indigenous Covid-19 vaccine being jointly developed by Bharat Biotech International (BBIL) — called Covaxin — has raised a storm within the scientific and medical community about the unrealistic timeline. That apart, it appears even the company may be unable to meet the target. Here’s why:
What ICMR wants: The ICMR has written a letter to 12 select hospitals across the country, practically warning them that “non-compliance will be viewed very seriously” if they failed to enrol human test subjects by next week Tuesday. The country’s governing body for medical research said that this measure was being taken “in view of the public health emergency due to Covid-19 pandemic” and that BBIL was “working expeditiously to meet the target”.
Really now? However, BBIL CMD Dr Krishna Ella, in an interview to The New Indian Express said on Thursday that he expects the “vaccine to be available early 2021“. In fact, BBIL, in its filing to the Clinical Trial Registry of India (CTRI) has stated that follow-ups for the clinical trial will be conducted on the 14th, 28th, 104th and 194th day — which clearly means a timeline of beyond 6 months. Additionally, the company lists the date of enrolment for the first phase of clinical trials from July 13 — almost a week after the ICMR’s deadline for enrolment.
Scrunch & crunch: Vaccine development is a long drawn process, usually spread over a number of years to determine any side-effects. Human clinical trials are a three phase process — starting from a small batch of healthy humans, usually between 40-50, moving on to a larger pool of over 100 with variations on dosage and frequency before the final phase, wherein randomly selected thousands or perhaps hundreds of thousands of volunteers are administered the vaccine.
Under fire: While independent experts have been aghast at the ICMR’s vaccine-by-deadline approach, the governing body’s chairperson of ethics advisory committee Vasantha Muthuswamy conceded (as reported by Scroll) that “a month to decide whether to release a vaccine is a very short time” and that even if the vaccine was fast-tracked, “it will take a minimum of one year“.