India’s first mRNA based Omicron-specific booster vaccine from Gennova gets DCGI approval

The Omicron specific mRNA vaccine will be available under the name – GEMCOVAC®-OM
Adults of 18 years of age and older can take the vaccine as booster dose
· The booster vaccine can be administered safely to individuals who have received two doses of either COVAXIN® or COVISHIELD™

· It is an intradermal vaccine which is administered using a needle-free device

· The vaccine is stable at 2-8 °C

Bangalore, June 20, 2023: Gennova Biopharmaceuticals Ltd, a Pune based company, announced that its mRNA COVID-19 booster vaccine – GEMCOVAC®-OM – against the Omicron variant of SARS-CoV-2 received Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI).

GEMCOVAC®-OM is the first booster COVID-19 vaccine developed in India against the highly transmissible Omicron variant. GEMCOVAC®-OM has demonstrated robust immune responses in the phase 3 clinical trial conducted at 20 centers across 13 cities in India In Phase-II/ III trials, approximately 3000 individuals received GEMCOVAC-OM and the vaccine was safe and well tolerated.

The currently approved vaccines used as precautionary/ booster doses are designed against the ancestral strain of SARS-CoV-2. Although these will increase the antibody titers, their ability to neutralize the circulating Omicron variant of SARS-CoV-2 is limited. Developing antibodies and memory immune responses specific to the Omicron variant would reduce the probability of infection and hospitalization and prevent future waves of the pandemic. The Made-in-India GEMCOVAC®-OM specifically addresses this gap.

GEMCOVAC®-OM is a lyophilized (freeze dried) vaccine, stable at 2- 8 °C.

It is delivered intradermally using a device called Tropis®, developed by PharmaJet, USA. This is a needle-free device that obviates the disadvantages of using a needle, such as a needle phobia, sharps disposal, and needle-stick injuries, to name a few.

Dr. Sanjay Singh, CEO, Gennova Biopharmaceuticals Limited, said: “The Gennova team, as a part of the global scientific community’s endeavour to meet unmet medical needs, is geared for dealing with health emergencies. There is a realization that the COVID-19 will remain and keep mutating, and therefore we need to be prepared with vaccines to deal with emerging variants. The mRNA platform, that was developed in association with the Department of Biotechnology, Government of India, provides an opportunity for a quick turnaround for vaccine development for any variants of concern in future, if any. Vaccines have remained the best shield for mankind against deadly diseases.”

Reiterating Gennova’s pursuit of research for finding solutions for better health, Mr. Samit Mehta, COO, Gennova Biopharmaceuticals Limited, said: “Gennova has successfully developed India’s first Omicron-variant vaccine within a few months. Being aware of the accessibility challenges the world witnessed for the COVID-19 vaccines, we are happy that we are providing a vaccine based on a state-of-the-art technology, the mRNA. We are thankful to our stakeholders – medical fraternity, government, scientific community – for espousing confidence in our effort towards the mRNA technology and now the Omicron specific vaccine. The mRNA vaccine platform continues to remain a protective shield for India and the world against Coronavirus”.

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