The Drug Controller General of India (DCGI) on June 29 granted permission to Bharat Biotech to initiate Phase I and II human clinical trials of its novel coronavirus, or COVID-19 vaccine.
The permission to conduct human trials was granted after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
"Results from these studies have been promising and show extensive safety and effective immune responses," the management said.
Human clinical trials are scheduled to start across India in July.
Bharat Biotech is developing a COVID-19 vaccine in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.
The indigenous, inactivated vaccine has been developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility located in Genome Valley, Hyderabad.
“The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” said Krishna Ella, Chairman and Managing Director of Bharat Biotech.
The vaccine was expedited through national regulatory protocols.Bharat Biotech said it has proven track record in developing vero cell culture platform technologies in several vaccines for polio, rabies, rotavirus, Japanese encephalitis, chikungunya and zika.