New Delhi, Aug 24 (UNI) Pune-based biotechnology firm Gennova Biopharmaceuticals Ltd has received approval from the Drug Controller General of India (DCGI) to conduct a phase II/III trial of its Covid-19 vaccine candidate in the country, the Centre informed on Tuesday.
The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III, the union government informed.
The company had submitted interim clinical data of the Phase I study of its vaccine to the Centre's Central Drugs Standard Control Organisation (CDSCO). The Subject Expert Committee (SEC) reviewed the data and found Gennova's jab, HGCO19, safe, tolerable, and immunogenic in the study participants, as per the information shared by the officials.
Gennova also submitted the proposed Phase II and Phase III study entitled "A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects" which has approved by the CDSCO, they added.
HGCO19 is the nation's first mRNA-based Covid-19 vaccine developed in partnership with the union government. It was partly funded by the Centre's Department of Biotechnology (DBT). Later on, the DBT further supported the program under its Mission COVID Suraksha, India's Covid-19 Vaccine Development programme.
Commenting on the development, Dr Renu Swarup, Secretary, DBT said that HGCO19 will be an important vaccine for both India and the world"It is a matter of great pride for India to have its own first mRNA-based Covid-19 vaccine. This is an important milestone in our indigenous vaccine development mission and positions India on the global map for novel vaccine development. We are confident that this will be an important vaccine for both India and the world," she added.
Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals said that the firm is investing in scaling up its manufacturing capacity to cater to the nation's vaccine requirement.
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