Gennova Biopharmaceuticals gets DCGI nod for mRNA-based Covid booster vaccine

The Drug Controller General of India (DCGI) has granted Emergency Use Authorisation (EUA) to an Omicron-specific booster vaccine developed using the indigenous platform technology by Pune-based Gennova Biopharmaceuticals in association with the Department of Biotechnology, Government of India. The booster vaccine will be available under the name - GEMCOVAC-OM, which can be administered safely to adults of 18 years of age and older who have received two doses of either Covaxin or Covishield. The vaccine uses spike protein of the omicron variant of the SARS-CoV-2 as an antigen.

The Department of Biotechnology (DBT) has facilitated establishing Gennova's mRNA-based next-generation vaccine manufacturing for developing the platform technology from proof of concept till phase 1 clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain. The project was further supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC).

 “GEMCOVAC-OM is the first booster Covid-19 vaccine developed in India against the highly transmissible Omicron variant,” Gennova said in a release.

Like the prototype vaccine, GEMCOVAC-OM is a thermostable vaccine, which does not require ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easy for deployment pan India. It is delivered intra-dermally using a needle-free injection device system. When administered intradermally in participants as a booster, it generated significantly higher immune responses.

As per the company, the vaccine has demonstrated robust immune responses in the phase 3 clinical trial conducted at 20 centers across 13 cities in India. In phase 2 and 3 trials, approximately 3,000 individuals received GEMCOVAC-OM and the vaccine was safe and well tolerated.

Sanjay Singh, CEO, Gennova Biopharmaceuticals Limited, says, “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 realisation that 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,” adds Singh.

As per the company, 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 neutralise 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 hospitalisation and prevent future waves of the pandemic.

The company claimed that the Made-in-India GEMCOVAC-OM specifically addresses this gap. It is a lyophilised (freeze dried) vaccine, stable at 2-8 °C.

The vaccine 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.

Pune-headquartered Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, is a biotechnology company engaged in the research and development, production, and commercialisation of biotherapeutics (biologics and vaccines) to address life-threatening diseases across various indications. It has commercialised seven products; 5 biosimilars, including one pioneering – a 'first-in-the-world' product.