“The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune,” said Bhargava.
SARS-CoV-2 is the virus that causes Covid-19.
Health experts, however, are sceptical about this. A senior doctor, who is a researcher in a public institute listed as a site for the clinical trials, said: “If the date is August 15, 2021, it is workable. Recruiting patients has not started. We will follow the due process, and are talking of human trials here. It is a serious business,” he said, adding that he was surprised the letter had come from a “man of science”.
The medical fraternity and vaccine developers suspect the letter has been written under “government pressure”. In fact, vaccine manufacturers expressed concern that they might be required to stick to similar timelines.
Globally, two vaccine candidates — Oxford University-AstraZeneca’s and Moderna’s — are considered to be frontrunners, but both are still a long way from a commercial launch.
AstraZeneca has started phase III human trials, while Moderna’s vaccine is set to begin final stage trials this month.
“We wait to see how it unfolds. Probably other vaccine projects would not be required if we can get a vaccine so quickly,” said a vaccine maker.
A doctor at one of the sites said the company had been in talks with them regularly. And it has done animal trials (including larger animals).
“The data from the animal trials showed promise and that is why the rush for the human trials,” he said.
Bhargava’s letter said the ICMR and Bharat Biotech were jointly working on the preclinical as well as the clinical development of this vaccine.
The ICMR could not be reached for a comment.
Earlier this week the company said it had completed pre-clinical trials (or animal trials) for its vaccine candidate Covaxin, and would start human trials in July. The company has approval for both phase 1 and phase 2 human trials from the drug regulator.
It also mentioned a list of clinical trial sites, which include the All India Institute of Medical Sciences (AIIMS), New Delhi.
The ICMR has asked these institutes to enable subject enrolment by the first week of July. “You are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7, 2020. And non-compliance will be viewed very seriously,” Bhargava’s letter said.
Public health experts have expressed shock at the way the letter has been written.
Anant Bhan, doctor and public health researcher, noted on twitter: “Let’s come to the tone of the letter. This reads more like a threat than a letter. ‘Get everything done by 07 July (in a letter dated 02 July) and start clinical trial participant recruitment’. Otherwise, non-compliance will be viewed seriously. By whom? The ICMR? Under what powers?”
Typically, vaccines take 5-10 years to develop. In this pandemic, the process has been expedited. Even then, experts say that phase 1 human trials, which test primarily the toxicity of a vaccine candidate on a small population, usually take a month, and phase 2 trials, which look at efficacy and determine the dosage, may take six months. Then the vaccine goes to phase 3, when it is tested on a much larger population and both safety and efficacy are tested. This takes another six to nine months.