Bharat Biotech gets nod for Phase-III trials of Covaxin
26 Oct 2020
Vaccine Innovator, Bharat Biotech on Tuesday said it has received regulatory approval for Phase III human trials of its novel Coronavirus (Covid-19) vaccine `Covaxin’ after successful completion of Phase II human trials.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) gave its nod to Bharat Biotech to conduct Phase-III trials of Covaxin at its meeting held in New Delhi on Tuesday.
The Sec accorded approval for Phase II human trials after Bharat Biotech presented data from Phase I and II trials, along with animal challenge data in two species, including non-human primates (NHP), on its inactivated Coronavirus vaccine, along with the proposal to conduct Phase-III clinical trials.
The SEC approval for the trials is subject to an amendment in the primary efficacy endpoint for symptomatic cases. The firm would cover 28,500 subjects aged 18 and above in its trials across 19 sites in the country.
'COVAXIN' was developed and manufactured at the company's Bio-safety Level-III high containment facility at Genome Valley, using adjuvant Alhydroxiquim-II to boost immune response and longer lasting immunity.
The technology is being used under licensing agreement with Kansas-based ViroVax LLC.
‘Covaxin’ is an inactivated vaccine derived from a strain of SARS-CoV-2 virus, isolated at the National Institute of Virology (NIV), Pune, an Indian virology research institute. The inactivated virus is formulated with ViroVax’s adjuvant to produce the vaccine candidate.
“Adjuvants 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,” says Dr Krishna Ella, chairman and managing director of Bharat Biotech
“The widely used adjuvant Aluminium hydroxide in the development of SARS CoV-2 vaccines is known to induce a Th2 based response (which are important for eradication of extracellular parasites and bacterial infection). The Th2 based response has a theoretical risk of vaccine associated enhanced respiratory diseases (VAERD or ADE). We have used Imidazoquinoline class of adjuvants (TLR7/8 agonists), which are known to induce Th1 based response which further reduces the risk of ADE (Anti Body Dependent Enhancement),” according to Dr Ella.
Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications.
Located in Genome Valley, the hub for the global biotech industry, the company has built a world-class vaccine and bio-therapeutics, research and product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution facility.