In a consequential move, Indian Council of Medical Research (ICMR), has partnered with Bharat Biotech International Limited (BBIL) to fast-track clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID Vaccine). It 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, says ICMR in a statement.
The ICMR DG in his letter urged investigators of medical colleges to treat the project on the highest priority and meet the given timelines without any lapse.
“In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to the initiation of the clinical trial and ensure that the subject enrollment is initiated no later than 7 July 2020,” Bhargava said in the letter.
“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials,” he added.
The vaccine is derived from a strain of SARS COV-2 isolated by ICMR-National Institute of Virology, Pune, ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine
Most experts are sceptical of the possibility of fast-tracking trials to such an extent that all three phases can be concluded within a month and a half.
“I would find it very surprising if it is done. Even the most ambitious companies in the world that are in more advanced stages of development for their Covid-19 vaccines have a longer time-frame,” said Dr Anant Bhan, Researcher, Global Health, Bioethics and Health Policy. “It also sounds unlikely, because the vaccine candidate is only moving to phase I and phase II trials right now.”
Currently, there are more than 100 vaccine candidates at different stages of trials across the world.