Clinical Trial of Covid-19 Vaccine: ZyCoV-D | 17 Jul 2020
Why in News
Recently, India has started phase I/II clinical trials of Covid-19 vaccine - ZyCoV-D, designed and developed by Zydus (a pharmaceutical company) with support from the Department of Biotechnology (DBT).
- The adaptive phase I/II clinical trials will assess the safety, tolerability and immunogenicity of the vaccine.
- The other indigenously developed vaccine - Covaxin - produced by Hyderabad based Bharat Biotech is also underway to start clinical trials.
- Description: ZyCoV-D, a plasmid DNA vaccine, comes under the Vaccine Discovery Programme supported by the Department of Biotechnology under the National Biopharma Mission.
- Plasmids are circular deoxyribonucleic acid (DNA) vectors that can be used as vaccines to prevent various types of diseases.
- Pre-Clinical Phase: It was found to initiate a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits.
- The antibodies produced by the vaccine were able to neutralize the wild type virus indicating the protective potential of the vaccine candidate.
- No safety concerns were observed in repeat dose by both intramuscular (directly into muscles) and intradermal (superficial injection into skin) routes of administration.
- DNA Vaccine Platform: The development of ZyCov-D has established the DNA vaccine platform in the country which is simple to deploy, temperature stable, and consistently manufacturable- thus lowering costs and enhancing the effectiveness of a vaccine.
- It provides ease of manufacturing the vaccine with minimal biosafety requirements.
- It has shown much improved vaccine stability and lower cold chain requirements making it easy for transportation to remote regions of the country.
- Furthermore, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates.
National Biopharma Mission
- It is an industry-academia collaborative mission for accelerating biopharmaceutical development in the country.
- It was launched in 2017 at a total cost of Rs. 1500 crore and is 50% co-funded by World Bank loan.
- It is being implemented by the Biotechnology Industry Research Assistance Council (BIRAC).
- BIRAC is a Public Sector Enterprise, set up by the Department of Biotechnology (DBT), Ministry of Science & Technology.
- Under this Mission, the Government has launched Innovate in India (i3) programme to create an enabling ecosystem to promote entrepreneurship and indigenous manufacturing in the biopharma sector.
- Objectives: Development of vaccines, medical devices, diagnostics and biotherapeutics besides, strengthening the clinical trial capacity and building technology transfer capabilities in the country.