In a major development, the Indian Council of Medical Research (ICMR), the apex body for the medical research in the country, on Thursday said that it will launch the coronavirus vaccine COVAXIN™ for the public use by August 15.
The country’s first coronavirus vaccine, which is developed in by ICMR in partnership with Hyderabad-based Bharat Biotech could be released by August 15 for the public use.
Hyderabad-based Bharat Biotech successfully developed COVAXIN™ in collaboration with the ICMR and National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech for the effort.
ICMR chief writes letter to all stakeholders
In a letter written to Bharat Biotech and principal investigators of medical colleges, ICMR Chief Balram Bhargava has asked for fast-tracking of the indigenous vaccine with an aim to launch by August 15.
“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.
The ICMR has asked a total of 12 institutes to fast track clinical trials of the vaccine as it is being considered among the highest 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 enrollment is initiated no later than 7, July 2020,” stated Dr Bharagava in a letter addressed to the clinical trial sites.
The ICMR in its letter to the selected institutes said that BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project.
Reportedly, the indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India. Last week, Bharat Biotech had received approval from the Drug Controller General of India (DCGI) to conduct phase I and II human clinical trials.