Recently, the Drug Controller General of India (DCGI) has approved the two-dose mRNA vaccine – country’s first homegrown mRNA Covid-19 vaccine, for emergency use for the age group 18 and above. The vaccine – GEMCOVAC-19, developed at Pune’s Gennova Biopharmaceuticals, is stable for storage at 2-8 degree C.
- Gennova already has a CDSCO licence to manufacture and sell the vaccine and has produced 70 lakh doses at risk, but now that it has received the Emergency Use Authorisation (EUA), it can ship the material as soon as all formalities are completed.
- mRNA-based vaccines must be stored and distributed at extremely low temperatures.
- Because India already has a cold supply chain infrastructure capable of handling refrigeration conditions, the novel mRNA vaccine candidate, GEMCOVAC-19, which is stable at 2-8°C, can be distributed across the country using the existing refrigeration supply chain.
- The vaccine will be available to adults over the age of 18 and the two doses will be administered intramuscularly 28 days apart.
What is an mRNA vaccine?
- mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.
- They are highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm.
- Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, e.g., eggs or bacteria. Therefore, they can be quickly manufactured inexpensively under cGMP conditions to ensure their “availability” and “accessibility” for mass vaccination on a sustainable basis.
About the vaccine –
- Funding for the vaccine was awarded under the ‘Mission COVID Suraksha – The Indian COVID-19 Vaccine Development Mission’ by DBT’s dedicated Mission Implementation Unit at Biotechnology Industry Research Assistance Council (BIRAC).
- DBT has been hand-holding Gennova’s right from the start and has facilitated establishing Gennova’s mRNA-based next-generation vaccine manufacturing platform by providing seed funding for the development of HGCO19. Gennova, in collaboration with HDT Biotech Corporation, USA, has developed the COVID-19 mRNA vaccine – GEMCOVAC-19 (earlier called HGCO19).