Phase I trials will be completed in two sites, KEM Hospital in Pune and Kohlapur government hospital for which 120 volunteers have been registered.
Gennova Biopharmaceutical’s vaccine candidate is the first mRNA-based vaccine to be produced in India. (Representative Image, IE)
After Covaxin and Covishield, now Pune-based drugmaker firm, Gennova Biopharmaceuticals is all set to start early to mid-stage human trials of its Covid-19 vaccine, HGCO19. The trials will start ‘’soon’’ and around 620 people will be enrolled for the vaccination programme in several cities in next few months.
Gennova CEO Dr Sanjay Singh talking to IE said that the firm will starts with the phase I trials soon and then present the data to the Drug Controller General of India (DGCI), before starting with the second phase and hence the regulatory authorities’ nod will determine when the trails will be completed.
Phase I trials will be completed in two sites, KEM Hospital in Pune and Kohlapur government hospital for which 120 volunteers have been registered. The enrollment process will begin soon. In phase II, 500 volunteers will be enrolled and will be conducted in six to ten sites, Singh further said.
Gennova Biopharmaceutical’s vaccine candidate is the first mRNA-based vaccine to be produced in India. Last week, the subsidiary of Emcure Pharmaceuticals, got conditional approval from DGCI for Phase I/II trials. If it passes through all the regulatory stages this will be the first vaccine that could potentially use India’s existing cold storage capacity for distribution.
Pfizer/BioNTech, Moderna vaccines that are being rolled out in the US and UK has also used the same mRNA platform to make the vaccine. Preliminary reports based on the data with respect to late-stage trails released by these two drugmakers suggest that the mRNA platform-based vaccines have 94-95 per cent efficacy.
This vaccine by Gennova can stay ‘stable’ at 2°C to 8°C for two months, says Ministry of Science and Technology. Pfizer/BioNTech vaccine on the other hand can stay stable only at -75°C and at 2°C to 8°C in refrigerated compartments for maximum five days. Moderna’s vaccine can also survive in refrigerated conditions for months.
Gennova vaccines are developed in collaboration with HDT Biotech Corporation in the US and have demonstrated immunogenicity, safety, neutralisation antibody activity in the rodent and non-human primate models, early reports suggest.