COVID-19 update | Gennova's indigenous mRNA vaccine HGCO19 gets nod for Phase I, II human trials

The Drug Controller General of India (DCGI) on December 12 approved the Phase I and II human clinical trial initiation for indigenous mRNA vaccine candidate HGCO19. The vaccine has been developed by Pune-based firm Gennova Biopharmaceuticals, the Ministry of Science and Technology stated.

Earlier, Gennova had claimed that its first messenger ribonucleic acid (mRNA) platform-based vaccine remained stable at 2-8 degrees Celsius.

The firm has received conditional permission for Phases 1 and 2 human clinical trials. The subject expert committee (SEC) has deliberated on its proposal before giving the conditional nod.

The way ahead for COVID-19 vaccine development and distribution in India

India’s first indigenous mRNA vaccine candidate has received approval from Indian Drug regulators to initiate Phase I/II human clinical trial. The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova, Pune: Ministry of Science & Technology

COVID-19 Vaccine

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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.

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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.

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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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— ANI (@ANI) December 11, 2020

The firm had submitted the application for clinical trial permission along with data from the animal toxicity study. However, the SEC observed that only after submitting the interim results of the Phase 1 study that the firm can proceed to the next phase trial. The DCGI has given permission for Phase I and II trials on similar conditions, Business Standard quoted.

For developing the vaccine, the Indian pharma firm has collaborated with Seattle-based HDT Biotech Corporation and received seed funding from the Department of Biotechnology.