NEW DELHI, Oct 12
Covaxin, the vaccine candidate developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) is in Phase 2 clinical trial in the country. And now the makers have sought approval from drug regulators to start the third phase clinical trial. As per reports, the Drugs Controller General of India (DGCI) has asked Bharat Biotech to submit "complete safety and immunogenicity data of the phase II trial" and some clarifications before proceeding for the next stage.
The results of their animal-based trial of the vaccine were found to be favourable. "The vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus."
The vaccine candidate has been tested in 12 hospitals across India, where volunteers between the ages of 18 and 55 participated in the trial. These volunteers had no co-morbidities. The places where the trial took place include Hyderabad, Delhi, Goa, Rohtak, Patna, Kancheepuram and Bhubaneswar, among other places.
The science behind the vaccine
Covaxin falls under the category of inactivated vaccines. For the unversed, this means that the virus pathogen is ‘deactivated’ to disable it from causing infection, however, some parts of the virus can be identified by the immune system, leading to an immune reaction.
Bharat Biotech took a strain of isolated coronavirus from the National Institute of Virology, Pune to develop the inactivated vaccine at its Hyderabad facility, Genome Valley.
The previous week, the firm shared that Covaxin will make use of ViroVax’s adjuvant Alhydroxiquim-II to boost immune response in the body and provide longer lasting immunity. "There is critical need for development and availability of adjuvants that elucidate mechanisms of action inducing greater antibody responses to vaccine antigens, thus resulting in long-term protection against pathogens. Adjuvants also enhance the sustainability of the global vaccine supply on account of their antigen-sparing effect," shared Krishna Ella, Chairman and Managing Director of Bharat Biotech. As per official statement from Bharat Biotech, once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves the immune system as a dead virus and mounts an antibody response towards the virus.
Phase 3 for Covaxin
To kickstart the phase 3 trial, Bharat Biotech will be enrolling 28,500 volunteers who will be older than 18 years. The trial will be carried out in 10 Indian States including Mumbai, Delhi, Patna and Lucknow.
As per reports from PTI, a dose of 0.5 ml on day 0 and 28 will be the administered dose for volunteers.
What to expect
Once the trials are done, Bharat Biotech will be targeting a manufacturing capacity of 300 million doses.
India is the largest vaccine producing country in the world and if India is able to produce an indigenous vaccine, it will help in fighting the capacity and managing the delivery capacity. ICMR has said that the vaccine candidate will follow all global norms to produce the most effective vaccine, which may take sometime. Times of India