Bharat Biotech-ICMR collaborates to launch COVID vaccine by August 15
Bharat Biotech and ICMR will be jointly working for the preclinical as well as the clinical development of this vaccine.
Bharat Biotech International Limited (BBIL) and Indian Council for Medical Research (ICMR) can now launch the indigenous Covaxin vaccine by August 15, 2020. ICMR and BBIL will be jointly working for the preclinical as well as the clinical development of this vaccine.
In an official statement, General Balram Bhargava, ICMR Director stated that ICMR aims to launch the COVID-19 vaccine for public health use by August 15 after the completion of all the clinical trials. He added that Bharat Biotech has been working expeditiously to meet the target.
ICMR has selected 12 institutes for the clinical trial of India's first indigenous COVID-19 Vaccine. ICMR also issued a letter to these institutes and asked them to fast track the clinical trials of the vaccine as this is a top priority project that is being monitored at the topmost level of the government.
DGCI approved Bharat Biotech Vaccine for human trials:
The Drug Controller General of India (DGCI) had earlier given its approval to the Indian vaccine manufacturer Bharat Biotech’s COVID vaccine. Bharat Biotech can now initiate phase-I and Phase-II human clinical trials for the COVID-19 vaccine candidate.
In a statement released by the company, the human clinical trials have been scheduled to start across India in July 2020.
DGCI granted permission for the human clinical trials after the vaccine make headquartered in Hyderabad submitted results that were generated from the preclinical studies which demonstrated immune response and safety.
Development of Vaccine by Bharat Biotech:
Bharat Biotech Chairman Dr. Krishna Ella announced the development of the first indigenous vaccine candidate Covaxin and mentioned that the collaboration with NIV and ICMR was instrumental in the vaccine development.
The SARS-CoV-2 strain was isolated in the National Institute of Virology and was transferred to Bharat Biotech. The company then developed the indigenous and inactivated vaccine at its Biosafety level- 3 high containment facility which is located in Genome Valley in Hyderabad Outskirts.
Bharat Biotech on getting approval from DGCI:
Krishna Ella stated that the guidance and proactive support from the Central Drugs Standard Control Organisation enabled the approvals to the project. He added that Bharat Biotech’s Research and Development and manufacturing teams have worked tirelessly to deploy proprietary technologies towards this platform.
The company further added that the results from the pre-clinical trial studies were promising and showed effective immune responses and extensive safety.
The Joint Managing Director Suchitra Ella mentioned that the company’s ongoing research and activities enabled in successfully manufacturing a vaccine for the H1N1 pandemic. She also added that the company created the only BSL-3 containment facilities for manufacturing and testing in India.
Other vaccines developed by Bharat Biotech:
The Vaccine producer headquartered in Hyderabad has developed several vaccines with the use of Vero Cell culture platform technologies. These vaccines developed by the company are Rotavirus, Polio, Rabies, Japanese Encephalitis, Zika, and Chikungunya.