Hyderabad firm to start human trials of vaccine candidate soon
Leading vaccine maker Bharat Biotech yesterday said that it has successfully developed Covaxin, India’s first vaccine candidate for Covid-19, in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) and will begin its human trials in July.
The Sars-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.
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 in Hyderabad, the company said in a statement.
The Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO), of the Health Ministry granted permission to start Phase I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
Human clinical trials are set to start across India next month.
“We are proud to announce Covaxin, India’s first indigenous vaccine against Covid-19. The collaboration with the ICMR and the NIV was instrumental in the development of this vaccine. The proactive support and guidance from the CDSCO has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” Dr Krishna Ella, chairman and managing director of Bharat Biotech said.
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies.
Results from these studies have been promising and show extensive safety and effective immune responses.
A Covid-19 seroprevalence screening is underway for a group of doctors, nurses and frontline workers at the J J Hospital, St Georges Hospital and G T Hospital in Mumbai, Eyebetes Foundation, one of India’s largest charitable initiatives for diabetes and blindness, said yesterday..
The foundation collaborated with the J J Group of Hospitals for the study, which began on June 23.
As part of the study, 200 doctors, 300 nurses and 300 frontline workers, including paramedical staff, cleaners, security personnel and administrative staff with patient contact, will undergo a simple blood test which will then be analysed for the presence of antibodies.
The study has been structured so that half the tests are conducted at J J Hospital, which is a non-Covid hospital, and half in dedicated covid hospitals such as St Georges Hospital and G T Hospital.
Establishing seroprevalence, the proportion of people previously infected, is essential to understand the true spread of Covid-19 in the community and then plan strategies to prevent further spread and more importantly, to plan policies for relaxing lockdown and related restrictions in a planned and phased manner.
The ICMR recently recommended the use of serological tests to evaluate the burden of the Covid infection in certain populations like frontline workers, nurses, doctors and other high-risk groups.
The blood test is not to diagnose an acute Covid-19 infection, but to evaluate past Covid-19 exposure.
“This is the largest study looking at seroprevalence in one of the most vulnerable groups - doctors, nurses and frontline workers working in Covid and non-Covid hospitals. Every study furthers our understanding of the disease,” Nishant Kumar, a trustee of the Eyebetes Foundation, said.
This study will also evaluate if people with a previous infection with Covid-19 who have antibodies can yet test positive for the disease.