India’s first indigenous vaccine against COVID-19 is likely to be launched by August 15.
The dramatic disclosure has come in the form of a signed note written late on Thursday (July 2) night by Dr Balram Bhargava, Director General of ICMR to medical institutes and universities that have been chosen as clinical trial sites.
If India succeeds in the effort it would be a major breakthrough in finding a cure for the pandemic that is tormenting the world affecting millions of lives.
Indian Council of Medical Research (ICMR) has set India’s Independence Day as the deadline for the launch of the anti-COVID-19 vaccine for public use.
ICMR is the apex body in India for the formulation, coordination and promotion of biomedical research and is one of the oldest medical research bodies in the world.
ICMR has tied-up with Bharat Bio-tech International Limited (BBIL), a Hyderabad based private sector company to fast track the clinical trials of BBV152 COVID vaccine.
Dr Bhargava in his letter has described it as 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 would be jointly working for the preclinical as well as clinical trials of the vaccine.
The note advises the chosen trial sites to “fast track all approvals related to the initiation of the clinical trial and ensure that the subject enrolment os initiated no later than July 7th, 2020.”
Dr Balram has also warned that “non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on highest priority and meet the given deadlines without any lapse”.
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.
The vaccine has already got permissions from the Drug Controller General of India, Central Drugs Standard Control Organisation and ministry of Health and Family Welfare to initiate Phase-I and II human trials following results submitted by the company obtained through preclinical studies. This has demonstrated the vaccine’s safety and immunity response.
Twelve institutions from all over India have been selected for the trails. The letters have been sent to Ethics Committee of All India Institute of Medical Sciences, Delhi and Patna; IMS and SUM hospitals, Odisha, King George Hospital Vishakhapatanam, PGIMS,Rohtak; NIMS Hyerabad; and SRM College Hospital and Research Centre, Tamil Nadu.