Covaxin, India’s first COVID-19 vaccine candidate has got the drug regulator’s approval to start the large scale phase III clinical trial in the country.
The Drugs Controller General of India asked the vaccine maker Bharat Biotech to submit the “complete safety and immunogenicity data of the phase II trial” and also urged for clarifications before proceeding for the next stage.
Indian Council of Medical Research (ICMR) has developed ‘Covaxin’ in collaboration with Bharat Biotech and it is in phase II clinical trial currently.
Hyderabad-based Bharat Biotech earlier released the animal study results of Covaxin saying, “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.”
Covaxin has been tested in 12 hospitals across the country, in the early stage of human trials. The vaccine trial took place in Hyderabad, Rohtak, Patna, Kancheepuram, Delhi, Goa, Bhubaneswar, and Lucknow among other places, including volunteers between the ages of 18 to 55 with no co-morbidity conditions who have participated in the trial.
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Last week the firm informed that Covaxin will use adjuvant Alhydroxiquim-II to boost immune response and to provide long lasting immunity. Under a licensing agreement with Kansas-based ViroVax the technology is being used, said Bharat Biotech.
Krishna Ella, chairman and managing director of Bharat Biotech said, “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.”
How does Covaxin work?
Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune. “Inactivated” vaccine at its high-containment facility at Genome Valley in Hyderabad has been developed by 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 to the immune system as a dead virus and mounts an antibody response towards the virus,” Bharat Biotech said.
The drugmaker plans to enroll 28,500 volunteers aged 18 years and above for the phase III trial and will be conducted across 10 states including Delhi, Mumbai, Patna and Lucknow. A dose of 0.5 ml on day 0 and 28 has been proposed in the phase III clinical trial application.
COVID-19 vaccine candidates in India
India’s coronavirus vaccine production and delivery capacity will help all humanity in fighting the pandemic, said Prime Minister Narendra Modi at the United Nations General Assembly last month.
“As the largest vaccine producing country of the world, I want to give one more assurance to the global community today. India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis,” he added.
Besides, Bharat Biotech, another vaccine candidate developed by Zydus Cadila Ltd is in the phase II of the human clinical trials.
Serum Institute of India has partnered with AstraZeneca for manufacturing the COVID-19 vaccine candidate developed by the University of Oxford.
Pune-based drugmaker is conducting Phase II and III human clinical trials of the candidate in India.