India plans to launch a vaccine for Covid-19 by August 15, said the head of a premier state-run medical research organisation, referring to a disease that has killed 625,544 people till now in the country.
The vaccine could be the world's first and is being developed in collaboration with the Bharat Biotech, said Dr Balram Bhargava, chief of Indian Council of Medical Research (ICMR) in a letter to research groups, prompting criticism from other companies and public health experts.
“This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the Government. The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National lnstitute of Virology, Pune,” said Bhargava. SARS-CoV-2 is the virus that causes Covid-19.
”ICMR and BBIL (Bharat Biotech International) are jointly working for the preclinical as well as clinical development of this vaccine. It is envisaged to launch the vaccine for public health use latest by August 15, 2020, 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,” he said.
ICMR could not be reached immediately and Bharat Biotech refused to 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 approvals for both phase 1 and phase 2 human trials from the drug regulator of India.
It also mentioned a list of clinical trial sites that include the All India Institute of Medical Sciences (AIIMS) in Delhi. Despite repeated attempts, Randeep Guleria, director of AIIMS, could not be reached.
ICMR has asked these institutions 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. Therefore, advised to treat this project on the highest priority and meet the given timelines without any lapse," said Bhargava’s letter.
The letter has created a furore in the scientific community. A representative of company in the fray to make a Covid-19 vaccine said that it is next to impossible to expedite clinical trials to that extent. "We wish them all the luck, as it can be India's first Covid19 vaccine. But, we seriously do not understand the science behind this," he said.
Public health expert Anant Bhan said on Twitter: "For a vaccine for which pre-clinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on 07th July? And that the vaccine will be launched on 15th August? A vaccine trial completed in little over a month, efficacy pre-decided?"
He questioned the eligibility criteria used to select the clinical sites mentioned in ICMR’s appendix. "Some of these seem to be small nursing homes/hospitals- are they the apt place to run a pandemic #vaccine trial?" Bhan's tweet said.