New Delhi: On Wednesday, the Central Drugs Standard Control Organisation allowed Pune-based Genova Biopharmaceuticals to direct Phase 1 and 2 clinical trials, alongside animal toxicity data, for its mRNA COVID-19 vaccine candidate.
It is India’s 1st messenger RNA (mRNA), COVID-19 vaccine candidate. Globally, US-situated pharma goliath Pfizer Inc has developed its mRNA vaccine.
The approval was given after the Subject Expert Committee (SEC) for vaccines recommended for grant of authorization in a review meeting on Wednesday, a document bearing the recommendations and accessed by IANS showed.
The document read, “After 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 before said it has given seed funding for the development of Genova’s novel self-amplifying mRNA-based vaccine candidate for COVID-19.
Genova has made its mRNA vaccine candidate (HGCO19) in a joint effort with HDT Biotech Corporation, US. The firm prior said that the vaccine showed safety, immunogenicity, neutralization antibody activity in the rodent and non-human primate models.
The DBT had stated in a statement earlier: “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 Genova’s novel self-amplifying mRNA-based vaccine candidate for COVID-19.”
The Union Health Ministry had said on Tuesday that upwards of 8 vaccine candidates for COVID-19 are under various stages of clinical trials and could be ready for authorization sooner rather than later.
The 8 vaccines are AstraZeneca and Oxford University made and Serum Institute of India manufactured Covishield, Covaxin by Bharat Biotech Ltd, ZyCoV-D by Zydus Cadila, NVX-CoV2373 by SII, HGCO19 by Geneva, Russian vaccine candidate Sputnik-V, and 2 unlabeled vaccines – Inactivated rabies vector platform by Bharat Biotech and the Recombinant Protein Antigen based vaccine by Biological E Ltd.
While the former five vaccine candidates are in either stage 2 or entered in stage 3 clinical trials, the last three are, as of yet, still in pre-clinical trial stages.
In the interim, two vaccine candidates- Covishield and Covaxin – are in the third phase of clinical trials. They have applied for emergency use approval to the Drug Controller General of India (DCGI). Their application is pending for authorization after the SEC discovered inadequate safety and efficacy information of the vaccines in its Wednesday review meeting.
The SEC has recommended furnishing further safety and efficacy information to both the organizations to get the emergency use authorization (EUA) of their COVID-19 vaccines.
