mRNA Covid-19 vaccine: The Pune-based biotechnology company had submitted the interim clinical data of the Phase-I study to the Central Drugs Standard Control Organisation (CDSCO).
New Delhi: On Tuesday, India’s first mRNA-based Covid-19 vaccine got the green light from India’s Comptroller General of Medicines (DCGI) to move to phase 2 and 3 trials. Reports show the Center informed that the vaccine developed by Genova Biopharmaceuticals Ltd. had been found to be safe and had been given the green light for phase II / III trials.
The Pune-based biotech company had submitted provisional clinical data from the Phase I study to the Central Drugs Standard Control Organization (CDSCO), the government’s national regulatory authority (NRA).
The Expert Committee on Vaccinated Subjects (SEC) reviewed interim data from Phase I and found that HGCO19 was safe, tolerable, and immunogenic in study participants, the Department of Science and Technology said. Technology in a press release.
Genova submitted the phase II and phase III study project entitled “A Prospective, Multicentric, Randomized, Active-Control, Observer-blind, Phase II study into seamlessly followed by a phase III study to assess safety, the safety, and immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects “which has been approved by the office of DCGI and CDSCO.
According to information shared by the Center, the Phase 2 study will be conducted in India at approximately 10-15 sites, while the Phase 3 study will be conducted at 22-27 sites.
Genova plans to use the sites of the DBT-ICMR clinical trials network for this study.
“Having established the safety of our HGCO19 mRNA-based COVID-19 vaccine candidate in Phase I clinical trial, Genova’s goal is to begin the pivotal Phase II / III clinical trial. At the same time, Genova is investing in increasing its manufacturing capacity to meet the country’s vaccine needs, ”said Dr. Sanjay Singh, CEO of Genova Biopharmaceuticals.
“It is with great pride that the country’s first mRNA-based vaccine has been proven to be safe and that India’s Controller General of Medicines DCG (I) has approved the Phase II / III trial. We are confident that this will be an important vaccine for This is an important milestone in our indigenous vaccine development mission and positions India on the global map of new vaccine development, ”said Dr. Renu Swarup, Secretary, DBT and President, BIRAC.
Genova’s mRNA-based coronavirus vaccine development program was partially funded by the Department of Biotechnology (DBT) of the Indian government under the Ind CEPI in June 2020. Later, the DBT has also supported the program as part of the COVID Suraksha – The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.
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