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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. It is India's first messenger RNA (mRNA), Covid vaccine candidate. Globally, US-based pharma giant Pfizer Inc has developed its mRNA vaccine.
The permission was granted after the Subject Expert Committee (SEC) for vaccines recommended for grant of permission in a review meeting on Wednesday.
In a document, the DCGI had stated that, after a detailed deliberation, the committee recommended for grant of permission to conduct Phase 1/2 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 Department of Biotechnology had earlier said it has provided seed funding for the development of Gennova's novel self-amplifying mRNA-based vaccine candidate for Covid-19.
Gennova has developed its mRNA vaccine candidate (HGCO19) in collaboration with HDT Biotech Corporation, US. The firm earlier said that the vaccine demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models.
In an earlier statement, the DBT has stated that "DBT-BIRAC has facilitated the establishment of the first-of-its-kind mRNA-based vaccine manufacturing platform in India. DBT has provided seed funding for the development of Gennova's novel self-amplifying mRNA-based vaccine candidate for COVID-19."
The Union Health Ministry had on Tuesday said that as many as eight vaccine candidates for Covid-19 are under different stages of clinical trials and could be ready for authorisation in the near future.
The eight vaccines include Astrazeneca and Oxford University developed and Serum Institute of India manufactured Covishield, Covaxin by Bharat Biotech Ltd, ZyCoV-D by Zydus Cadila, Russian vaccine candidate Sputnik-V, NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabeled vaccines -- the Recombinant Protein Antigen based vaccine by Biological E Ltd and Inactivated rabies vector platform by Bharat Biotech.
While the former five vaccine candidates are in either phase 2 or entered in phase 3 clinical trials, the latter three are still in pre-clinical trial phases.
Meanwhile, two vaccine candidates -- Covishield and Covaxin - are in the third stage of clinical trials. They have applied for emergency use authorisation to the Drug Controller General of India (DCGI). Their application is pending approval after the SEC found inadequate safety and efficacy data of the vaccines in its Wednesday review meeting.
The SEC has recommended furnishing further safety and efficacy data to both the firms to receive the emergency use authorisation (EUA) of their Covid vaccines.
(With inputs from IANS)
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