India's first mRNA Covid vaccine candidate gets nod to start phase 1 trials

The Covid-19 vaccine candidate is being developed by Gennova Biopharmaceuticals, a Pune-based firm, in collaboration with HDT Biotech Corporation, USA.

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India's first mRNA Covid vaccine candidate gets nod to start phase 1 trials
The Department of Biotechnology has provided seed funding for development of Gennova's novel self-amplifying mRNA-based vaccine candidate for Covid-19. (Photo: Reuters)

The Drugs Controller General of India (DCGI) has given conditional approval for Phase 1 and 2 clinical trials of India's first mRNA Covid-19 vaccine candidate -- HGCO19 -- that is being developed by Gennova Biopharmaceuticals.

Gennova Biopharmaceuticals, a Pune-based firm, is developing the vaccine candidate in collaboration with HDT Biotech Corporation, USA.

The conditional approval for human clinical trials were given after the recommendation of India's Subject Expert Committee (SEC) on Covid-19. The committee deliberated upon the proposal submitted by the firm for grant of permission to conduct phases 1 and 2 clinical trials, along with animal toxicity study data. Following the assessment by SEC, DCGI gave its approval for the clinical trials.

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"After detailed deliberation, the committee recommended for grant of permission to conduct phase 1 and 2 clinical trial subject to the condition that the interim results of phase 1 study shall be submitted to the committee before proceeding to the next phase," the SEC recommendations stated.

The Department of Biotechnology has provided seed funding for the development of Gennova's novel self-amplifying mRNA-based vaccine candidate for Covid-19.

Quoting the department about the vaccine, PTI reported Gennova has developed an mRNA vaccine candidate, with demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models.

(With PTI inputs)

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