New Delhi: The Indian Council of Medical Research (ICMR) DG Balram Bhargava has written a letter to Bharat Biotech and principal investigators of medical colleges to complete the trial procedure of indigenous COVID-19 vaccine in a fast track method, so that results of a clinical trial can be launched by August 15.
Bharat Biotech had recently received a nod for a clinical trial of its vaccine – Covaxin. “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 Institute of virology. Pune- ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine,” the letter read. A total of 12 institutes have been asked by the ICMR to fast track clinical trials of the vaccine as it is being considered the topmost priority projects which are being monitored by the government.
“You have been chosen as a clinical trial site of the BBV152 COVID Vaccine. 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 enrolment is initiated no later than 7, July 2020,” stated Dr Bharagava in a letter.
It is worth noting that earlier a letter from the ICMR DG to Bharat Biotech leaked out claimed that the vaccine would be ready by August 15. However, when asked ICMR clarified that the purpose of the letter was to expedite trials so that results could be available by August 15, the vaccine would need more time for public use. “Kindly note that non-compliance will be viewed very seriously, therefore you are advised to treat this project on the highest priority and meet the given timelines without any lapse,” the letter added.