ICMR in a letter has asked hospitals and health institutes conducting human clinical trials to fast track process.
The Drugs Controller General of India on Monday approved Bharat Biotech to conduct phase I and II of human clinical trials of its Covaxin vaccine. (Photo: The Financial Express)The Indian Council of Medical Research (ICMR) has written to hospitals and health institutions to “fast-track” the human clinical trials of Covaxin, India’s first Covid-19 vaccine candidate to get approval for human trials, as it aims to launch the vaccine for public use latest by August 15.
Leading biotech firm Bharat Biotech has developed Covaxin in collaboration with the National Institute of Virology (NIV). The Drugs Controller General of India (DCGI), the country’s drug regulator, on Monday had approved Bharat Biotech to conduct phase I and II of human clinical trials of its Covaxin vaccine.
ICMR director general Balram Bhargava, in a letter to hospitals selected for conducting the clinical trials, has said it is one of the “top priority projects,” adding “in view of a public health emergency,” all the stakeholders are being “strictly advised to fast track all approvals related to the initiation of the clinical trial, and ensure that the subject enrolment is initiated no later than July 7, 2020.”
According to the letter, ICMR aims to launch the vaccine for public use latest by August 15 after completion of all clinical trials.
However, health experts are of the view that the deadline set by ICMR is “totally unrealistic if not entirely impossible”.
“August 15 is a completely unrealistic target, said Vineeta Bal, an immunologist and a visiting professor at the Indian Institute of Science Education and Research (IISER) in Pune, as reported by the Indian Express. Bal said she is unable to comprehend how the vaccine could be ready so soon, which is still under trial.
“There are several processes involved, and even in the best-case scenario, considering that we are in an emergency situation, the August 15 timeline seems totally unrealistic, if not entirely impossible,” she said.
Anant Bhan, who works on bioethics, also raised his concern about the August 15 deadline. “For a vaccine for which pre-clinical development is still ongoing, as per (ICMR’s) letter itself, how can clinical trial recruitment be starting on July 7?,” Bhan said on his tweet, as reported by The Indian Express.
“And that the vaccine would be launched on August 15? A vaccine trial completed in little over a month, efficacy pre-decided?,” Bhan said.
According to health experts, these trials usually take months to complete. And these trails need to be followed by data analysis and verification. Then the outcome usually gets published in a peer-reviewed journal before the vaccine is cleared for public use; though some of these processes can be expedited, or even bypassed, but not all.
However, ICMR scientist Lokesh Sharma, Scientist said that not to consider August 15 as the deadline. “This is our aim, which depends on the cooperation of institutes”.
”If we are going to start work, we should do so with an aim and it should be of success. Our expectation and aim is that the trial will be complete. Anyway, the product is ready. Hence, we are going into trials, he added.