India’s first mRNA-based COVID antibody ‘safe’, gets DCGI gesture for Phase 2/3 preliminary

KEY STORY 

• India’s first mRNA-based COVID-19 vaccine has received a nod from the Drugs Controller General of India (DCGI) to move into Phase II/III trial.

• The mRNA-based vaccine HGCO19, developed in partnership with Department of Biotechnology (DBT)-Biotechnology Industry Research Assistance Council (BIRAC), has been found to be safe and immunogenic.

• Gennova Biopharmaceuticals Ltd., the Pune-based biotechnology company, working on the mRNA-based vaccine, submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Centre’s National Regulatory Authority (NRA).

• Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study, according to the government.

• Gennova 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 was approved by the office of the DCGI, CDSCO, a press release said.

• The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study, the released added.

• Gennova’s mRNA-based COVID-19 vaccine development program was partly funded by the DBT, Centre under Ind CEPI, way back in Jun 2020.

• Later on, the DBT further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.

CONCLUSION

• Renu Swarup, Secretary, DBT and chairperson, BIRAC said that “It is a matter of great pride that country’s first mRNA-based vaccine is found to be safe and the Drugs Controller General of India DCGI has approved Phase II/III trial.

• We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the global map for novel vaccine development.”

• Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd., said that “After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in Phase I clinical trial, Gennova’s focus is to start Phase II/III pivotal clinical trial. In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation’s vaccine requirement.”