India's First Indigenous Omicron-Specific Booster Vaccine Approved

In a major step towards its fight against COVID-19, the government has approved the emergency use of an Omicron-specific mRNA-based booster vaccine, named GEMCOVAC®-OM, developed using the indigenous platform technology, the first such vaccine made in the country.

The revolutionary vaccine uses a stable mRNA platform, similar to the prototype vaccine developed against the Wuhan stain. However, what sets it apart is its ability to generate a robust immune response specifically targeting Omicron variant. This is a critical step in tackling the evolving nature of the virus, thereby safeguarding public health.

The Department of Biotechnology (DBT) announced that the Drug Control General of India (DCGI) has given green signal for the vaccine that was developed by Pune-based domestic firm Gennova Biopharmaceuticals, supported under the Mission COVID Suraksha and implemented by Biotechnology Industry Research Assistance Council (BIRAC).

One remarkable feature of this vaccine is its thermostable nature, which means it does not require ultra-cold chain infrastructure for storage and distribution. Unlike some other mRNA-based vaccines, GEMCOVAC®-OM can be stored and transported at temperatures ranging from 2 to 8 degree Celsius, leveraging existing infrastructure and making it easily deployable across the country.

During the clinical trials conducted as a booster shot, this vaccine demonstrated significantly higher immune responses when administered intradermally using a needle-free injection device. The clinical outcome demonstrates the need for variant-specific vaccines for desired immune response.

The DBT has facilitated establishing Gennova's mRNA-based next-generation vaccine manufacturing for developing the platform technology from proof of concept till Phase-I clinical trials. The project was further supported under 'Mission COVID Suraksha' and 'Indian COVID-19 Vaccine Development Mission' of DBT's dedicated Mission Implementation Unit at BIRAC, for further clinical development and scale-up of the prototype vaccine, as per an official release.

Speaking on the development, Gennova CEO Dr. Sanjay Singh, said, "GEMCOVAC®-OM's getting DCGI authorisation is a testimony of our efforts to initiate, nurture and enable this 'pandemic-ready' technology. India has now developed not one but two mRNA vaccines against COVID-19 using this rapid-disease-agnostic platform technology."

Commending the efforts of the DBT team, Union Minister of Science & Technology Dr. Jitendra Singh said, "Yet again, DBT has fulfilled its mission -- enabling technology-driven entrepreneurship through creating this indigenous mRNA-platform technology. We have always supported technology-driven innovation towards the creation of a 'future-ready' technology platform."

"Infrastructure to deploy vaccine in India, including LMICs, at 2-8 degree C exists today and this innovation is tailored for the existing established supply-chain infrastructure. The vaccine does not need ultra-low temperature conditions for transport and storage," he added.

DBT Secretary and BIRAC Chairperson Dr. Rajesh Gokhale said that strategic infusion of funds is essential to drive and create an ecosystem for technological innovation, and DBT did just that when it provided support for the development of the nation's first mRNA-based platform technology.

This is a disease-agnostic platform and can be used to make other vaccines in a relatively short developmental timeline. Clinical Trial Networks with Consortia of Hospitals was supported by NBM-DBT and the same sites were used for the mRNA vaccine clinical trials, he added.