Bharat Biotech Ltd. has started its first phase of human clinical trials for the COVID-19 vaccine candidate Covaxin. The indigenous vaccine is developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research-Pune based National Institute of Virology (NIV).
As per the ICMR official, volunteers at 14 locations across the country have been undergoing what is termed as 'safety and screening' study in order to check all the parameters, which includes liver functions, infections, or possible exposure to COVID-19.
Bharat Biotech International Limited (BBIL) and Indian Council for Medical Research (ICMR) had earlier announced that the indigenous Covaxin vaccine will be launched by August 15, 2020. It will be the first indigenous vaccine for the treatment of COVID-19.
The first phase of human clinical trials for Covaxine starts:
The senior official of ICMR has informed that after an all-clear from the 'safety and screening' study, the subjects participating in the trial will be given a 'naive' status, which means that they can be administered small doses of the vaccine.
Currently, ICMR-NIV added an additional protocol of conducting an antibody test on the volunteers which will help further in knowing whether the person has been infected by the virus. If they have, they will not be able to participate in the further stages of the trial.
The trials will have a considerable sample size of 1,500 people. The locations for the trials include Kanpur, Patna, Chennai, New Delhi, Gorakhpur, Goa, Rohtak, Bhubaneshwar, Hyderabad, and Vishakhapatnam.
ICMR and Bharat Biotech set to launch Covaxine on August 15:
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.
The officials had informed that both ICMR and Bharat Biotech have been jointly working for the preclinical as well as the clinical development of this vaccine.
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 Covaxine 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.
Covaxine developed 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.
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