September 26, 2023
22-0001-010 (7002015)

Gennova Biopharmaceuticals Launches Gemcovac, the First Indigenous mRNA-Based Vaccine for Omicron Variant”

In a significant milestone for India’s fight against the Omicron variant of COVID-19, Pune-based Gennova Biopharmaceuticals has successfully launched Gemcovac, the country’s first indigenously developed mRNA-based vaccine. The booster vaccine, specifically targeting the Omicron variant, was unveiled by Union Minister of State (I/C) Science & Technology, Jitendra Singh, during a ceremonial event held in New Delhi.

Distinguishing itself from the globally known mRNA shots produced by Pfizer and Moderna, Gemcovac utilizes the mRNA method in a unique manner. Although efficacy data for the vaccine is yet to be released by the manufacturers, Gennova Biopharmaceuticals has previously stated that an earlier version of the vaccine, which underwent clinical trials, demonstrated no decrease in immune response compared to other approved doses in the country.

Expressing his pride in the Department of Biotechnology (DBT) for enabling technological advancements through indigenous mRNA-platform technology, Minister Jitendra Singh emphasized the accomplishment of the DBT’s mission in promoting technology-driven entrepreneurship.

Gemcovac, developed with the support and funding from the DBT and Biotechnology Industry Research Assistance Council (BIRAC), has obtained emergency use authorization from the Drug Control General of India. The DBT played a crucial role in assisting Gennova Biopharmaceuticals in navigating the entire process, from proof of concept to the initial phase of clinical trials. The utilization of mRNA technology facilitates faster vaccine development and production scale-up.

An advantage of Gemcovac lies in its elimination of the need for ultra-cold chain infrastructure, which is typically required for other mRNA-based vaccines. This feature makes distribution across India significantly easier. The vaccine is administered through a needle-free injection device, delivering it under the skin.

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The DBT noted that Gemcovac, when administered as a booster via intradermal injection, generated substantially higher immune responses in participants. This clinical outcome underscores the importance of variant-specific vaccines for achieving the desired immune response.

Amid the rise of the Omicron variant, research institutions worldwide have been striving to develop variant-specific vaccines, bivalent vaccines, and variant-proof vaccines, aiming to enhance immunity against emerging strains. Last year, British authorities granted approval for a Moderna dose adapted to provide protection against the Omicron variant, marking the first redesigned COVID vaccine. Other companies, including Pfizer, AstraZeneca, and Novavax, have also made progress in developing updated COVID vaccines with improved efficacy against emerging variants.

Minister Jitendra Singh credited the steady investments made by the Indian government in creating a robust entrepreneurship and startup ecosystem, which greatly facilitated the country’s response to mitigating the COVID-19 pandemic.

The launch of Gemcovac represents a significant achievement for India’s biopharmaceutical industry and reinforces the nation’s commitment to developing indigenous solutions to combat the challenges posed by evolving COVID-19 variants. With the introduction of Gemcovac, India takes a significant step forward in its vaccination efforts against the Omicron variant, offering renewed hope in the ongoing battle against the pandemic.