Gennova’s mRNA-based COVID-19 vaccine gets approval for Phase 2/3 clinical trials


PTI, Aug 24, 2021, 5:12 PM IST

New Delhi: India’s first mRNA-based COVID-19 vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been granted approval for Phase 2/3 clinical trails, the Department of Biotechnology (DBT) said on Tuesday.

The Pune-based biotechnology company had submitted the interim clinical data of the vaccine”s Phase 1 study to the Central Drugs Standard Control Organisation (CDSCO), it said.

The Vaccine Subject Expert Committee (SEC) reviewed the interim Phase 1 data and found that the HGCO19 vaccine was safe, tolerable, and immunogenic in the participants of the study.

“Gennova submitted the proposed Phase 2 and Phase 3 study entitled ”A Prospective, Multicentre, Randomised, Active-controlled, Observer-blind, Phase 2 study seamlessly followed by a Phase 3 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 DCG(I), CDSCO,” the DBT said.

The study will be conducted in the country at approximately 10-15 sites in Phase 2 and 22-27 sites in Phase 3. Gennova plans to use the DBT-ICMR clinical trial network sites for this study, it said.

Gennova”s mRNA-based COVID-19 vaccine development programme was partly funded by the DBT under Ind CEPI in June 2020.

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

Renu Swarup, Secretary of DBT and Chairperson of Biotechnology Industrial Research Assistance Council (BIRAC), said this is an important milestone in the country”s indigenous vaccine development mission, and it positions India on the global map for novel vaccine development.

Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd, said, “After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in Phase 1 clinical trial, Gennova”s focus is to start Phase 2/3 pivotal clinical trial.

“In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation”s vaccine requirement,” he said.

Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.

Top News

Fishing vessel collides with naval platform off Goa coast; 2 fishermen missing

‘Nation First’ key to India’s progress, says President Murmu

Karnataka BJP chief Vijayendra slams Cong govt over Waqf notices to farmers, fund crunch

Man declared dead wakes up before cremation, 3 doctors suspended in Rajasthan

Teen stabs man to death at railway station in Mumbai after quarrel over local train seat

BJP stages protest against Karnataka govt over Waqf properties row

Youth attempts suicide after being humiliated in public for wearing ripped jeans in Belthangady

Related Articles More

Fishing vessel collides with naval platform off Goa coast; 2 fishermen missing

Cal HC stays demolition of illegal constructions in Mandarmoni

Delhi LG praises CM Atishi, calls her ‘thousand times better than her predecessor’

Kharge confident of Cong and allies coming to power in Maharashtra, Jharkhand

‘Nation First’ key to India’s progress, says President Murmu

MUST WATCH

Christmas Cake Fruit Mixing

DK Shivakumar

Rose Cultivation

Geethotsava

Naxal Operation


Latest Additions

Fishing vessel collides with naval platform off Goa coast; 2 fishermen missing

BGT Day 1: Bumrah leads India’s spectacular bowling comeback after batting no-show

Cal HC stays demolition of illegal constructions in Mandarmoni

Delhi LG praises CM Atishi, calls her ‘thousand times better than her predecessor’

Centre releases 15th Finance Commission grant for rural local bodies in Karnataka

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.