Pune-based Gennova Biopharmaceuticals became the first pharmaceutical in India to use messenger RNA (mRNA) COVID-19 vaccine candidate, after the Central Drugs Standard Control Organisation on Wednesday approved it to conduct Phase 1 and 2 clinical trials, along with animal toxicity data. Globally, US-based pharma giant Pfizer Inc and Moderna have developed its mRNA vaccine. However, the approval was granted with a condition.
The permission was granted after the Subject Expert Committee (SEC) for vaccines recommended for grant of permission in a review meeting on Wednesday, a document carrying the recommendations and accessed by IANS showed.
"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 document read.
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.
"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 DBT had said in a statement earlier.
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 for 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.