The Drugs Controller General of India (DCGI) has given Pune-headquartered Gennova Biopharmaceuticals the green light to start early- to mid-stage human testing of its Covid-19 vaccine candidate. If successful, the candidate may be the first indigenously developed vaccine using mRNA technology that could potentially use India’s existing cold chain capacity.
This is the same platform used by Pfizer and BioNTech as well as Moderna and the US National Institutes of Health (US NIH) to make their vaccines. Preliminary information released by the two companies on late stage trials of their vaccines show that they have an efficacy of around 94-95 per cent, which means they have the potential to cut down symptomatic Covid-19 cases by up to 95 per cent among those vaccinated.
Gennova’s candidate, known as HGCO19, is “stable” at 2°C to 8°C for two months, according to the Ministry of Science and Technology. On the other hand, Pfizer and BioNTech’s vaccine requires deep freeze technology to be stored at around -75°C and can be kept in 2°C to 8°C refrigerated units for up to five days. Moderna’s candidate with the National Institute of Allergy and Infectious Diseases under the US NIH can survive in these refrigerated temperatures for up to a month.
“Gennova has completed all preliminary work and should be initiating the Phase I/II Human clinical trial soon since the approval from the DCGI office has been received,” said the Ministry. The candidate was supported with a seed grant under the Ind-CEPI mission of Department of Biotechnology under the Ministry of Science and Technology. It was developed in collaboration with Seattle-based HDT Biotech Corporation.
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