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Gennova gets DCGI nod to conduct Phase 2,3 trials of its mRNA COVID-19 vaccine

The study will be conducted in India at 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 the study.

August 24, 2021 / 05:53 PM IST
Representative image.

Representative image.

Gennova Biopharmaceuticals, the Pune-based biotechnology company which is developing India's first mRNA-based COVID-19 vaccine HGCO19, on August 24 received approval from the Drug Controller General of India (DCGI) to conduct Phase 2 and Phase 3 clinical trials.

Gennova submitted the proposed Phase II and Phase III study titled 'A Prospective, Multicentre, Randomised, 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.

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 company submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India's National Regulatory Authority (NRA).

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

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Gennova's mRNA-based COVID-19 vaccine development programme was partly funded by the Department of Biotechnology (DBT), under Ind CEPI, way back in June 2020.

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

“It is a matter of great pride that Nation’s first mRNA-based vaccine is found to be safe and the Drugs Controller General of India DCG(I) has approved Phase II/III trial," said Renu Swarup, Secretary, DBT and Chairperson, BIRAC.

Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd., said: “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."
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Aug 24, 2021 05:53 pm

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