Gennova Biopharmaceuticals Ltd on Tuesday announced that its mRNA COVID-19 booster vaccine have recieved Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI).
According to a press statement, the vaccine, GEMCOVAC-OM is approved against the Omicron variant of SARS-CoV-2.
The company stated that 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.
“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,” Dr. Sanjay Singh, CEO, Gennova Biopharmaceuticals Limited, said in a statement.
According to Samit Mehta, COO, Gennova Biopharmaceuticals Limited, 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,” Mehta said on Tuesday.
