Mission COVID Suraksha

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20-Jun-2023: Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology

The Department of Biotechnology (DBT) has announced that the Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology by Gennova Biopharmaceuticals Ltd. and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC), has got a nod from the office of the Drug Control General of India (DCGI) for Emergency Use Authorization (EUA).

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 trial of the prototype mRNA-based vaccine developed against the Wuhan strain. The project was further supported under the 'Mission COVID Suraksha'. The Indian COVID-19 Vaccine Development Mission' by DBT's dedicated Mission Implementation Unit at Biotechnology Industry Research Assistance Council (BIRAC), for further clinical development and Scale up of the prototype vaccine, which received EUA on 29th June 2022. The platform technology developed was used to develop an Omicron-specific booster vaccine for COVID-19.

GEMCOVAC®-OM is an Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology by Gennova in collaboration with DBT. 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. The clinical outcome demonstrates the need for variant-specific vaccines for desired immune response.

Dr. Jitendra Singh, Union Minister (IC), Ministry of Science and Technology, commended the efforts of team DBT and said, that "I take great pride in DBT fulfilling its mission yet again – 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 in line with the Prime Minister’s vision of Aatmanirbharta. Minster also said, "Infrastructure to deploy vaccine in India, including LMICs, at 2‑8°C exist today & this innovation is tailored for the existing established supply-chain Infrastructure. The vaccine does not need ultra-low temperature conditions for transport and storage."

Dr Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC 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 said.”

Speaking on the development, CEO of Gennova Biopharmaceuticals Ltd, Dr. Sanjay Singh, said, "When we started the development of this platform technology and took the proposal to DBT, the Government believed in our capability to develop an mRNA technology platform, and we did it. GEMCOVAC®-OM's getting EUA from the office of the DCG(I) 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. I am proud that my team has worked tirelessly over the last two years to develop the nation's first mRNA vaccine. This is a team effort & without the guidance of the Subject Expert Committee of CDSCO and the Vaccine Expert Committee of BIRAC monitoring the project, it would not have been possible."

About DBT: The Department of Biotechnology (DBT), under the Ministry of Science & Technology, promotes and accelerates the development of biotechnology in India, including the growth and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment, and industry.

About BIRAC: Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, set up by the Department of Biotechnology (DBT), Government of India, as an Interface Agency to strengthen and empower the emerging Biotech enterprises to undertake strategic research and innovation, addressing nationally relevant product development needs.

About Gennova: Gennova Biopharmaceuticals Ltd., headquartered in Pune, India, is a biotechnology company dedicated to the research and development, production, and commercialization of biotherapeutics (biologics and vaccines) to address life-threatening diseases across various indications. To find out more, visit https://gennova.bio

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20-Jun-2023: Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology

The Department of Biotechnology (DBT) has announced that the Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology by Gennova Biopharmaceuticals Ltd. and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC), has got a nod from the office of the Drug Control General of India (DCGI) for Emergency Use Authorization (EUA).

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 trial of the prototype mRNA-based vaccine developed against the Wuhan strain. The project was further supported under the 'Mission COVID Suraksha'. The Indian COVID-19 Vaccine Development Mission' by DBT's dedicated Mission Implementation Unit at Biotechnology Industry Research Assistance Council (BIRAC), for further clinical development and Scale up of the prototype vaccine, which received EUA on 29th June 2022. The platform technology developed was used to develop an Omicron-specific booster vaccine for COVID-19.

GEMCOVAC®-OM is an Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology by Gennova in collaboration with DBT. 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. The clinical outcome demonstrates the need for variant-specific vaccines for desired immune response.

Dr. Jitendra Singh, Union Minister (IC), Ministry of Science and Technology, commended the efforts of team DBT and said, that "I take great pride in DBT fulfilling its mission yet again – 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 in line with the Prime Minister’s vision of Aatmanirbharta. Minster also said, "Infrastructure to deploy vaccine in India, including LMICs, at 2‑8°C exist today & this innovation is tailored for the existing established supply-chain Infrastructure. The vaccine does not need ultra-low temperature conditions for transport and storage."

Dr Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC 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 said.”

Speaking on the development, CEO of Gennova Biopharmaceuticals Ltd, Dr. Sanjay Singh, said, "When we started the development of this platform technology and took the proposal to DBT, the Government believed in our capability to develop an mRNA technology platform, and we did it. GEMCOVAC®-OM's getting EUA from the office of the DCG(I) 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. I am proud that my team has worked tirelessly over the last two years to develop the nation's first mRNA vaccine. This is a team effort & without the guidance of the Subject Expert Committee of CDSCO and the Vaccine Expert Committee of BIRAC monitoring the project, it would not have been possible."

About DBT: The Department of Biotechnology (DBT), under the Ministry of Science & Technology, promotes and accelerates the development of biotechnology in India, including the growth and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment, and industry.

About BIRAC: Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, set up by the Department of Biotechnology (DBT), Government of India, as an Interface Agency to strengthen and empower the emerging Biotech enterprises to undertake strategic research and innovation, addressing nationally relevant product development needs.

About Gennova: Gennova Biopharmaceuticals Ltd., headquartered in Pune, India, is a biotechnology company dedicated to the research and development, production, and commercialization of biotherapeutics (biologics and vaccines) to address life-threatening diseases across various indications. To find out more, visit https://gennova.bio

2021

24-Aug-2021: India’s First COVID-19, mRNA vaccine developed in partnership with DBT-BIRAC under Mission COVID Suraksha

Gennova Biopharmaceuticals Ltd., the Pune-based biotechnology company, working on the nation's first mRNA-based COVID-19 vaccine, submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India's National Regulatory Authority (NRA).

Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study.

Gennova submitted the proposed Phase II and Phase III study entitled "A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects" which was approved by the office of the DCG(I), CDSCO.

The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study.

Gennova's mRNA-based COVID-19 vaccine development program was partly funded by the Department of Biotechnology (DBT), Govt. of India under Ind CEPI, way back in Jun 2020. Later on, the DBT further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.

Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC said that “It is a matter of great pride that Nation’s first mRNA-based vaccine is found to be safe and the Drugs Controller General of India DCG(I) has approved Phase II/III trial. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development.”

Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd., said that “After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in Phase I clinical trial, Gennova’s focus is to start Phase II/III pivotal clinical trial. In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation's vaccine requirement.

13-Aug-2021: Indian Immunologicals receive manufacturing license under Department of Biotechnology - Mission Covid Suraksha Project for Augmentation of Manufacturing Capacity for COVAXIN

Department of Biotechnology and BIRAC under the Mission Covid Suraksha announced by the Government of India, under Atmanirbhar Bharat 3.0 to accelerate the development and production of Indigenous COVID Vaccines, have launched a project to augment production capacities of Covaxin.

Indian Immunologicals limited, Hyderabad, is the first site under this project to receive from CDSCO, a loan license for supplying Covaxin Drug Substance produced at its repurposed facility to Bharat Biotech. Indian Immunologicals will supply the first lot of commercial Covaxin Drug Substance to Bharat Biotech on 13th August 2021. The facility will produce 2-3 million doses per month initially, and another 4-5 million doses from its new facility at Karkapatla, in next few weeks.

Speaking on this achievement Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, ‘’The government has worked relentlessly to provide all possible support for ramping up Covaxin production in the country and speed up Covaxin inoculation drive. The loan license agreement by CDSCO for Indian Immunologicals to produce Covaxin Drug Substance is a major milestone, achieved in a very short span of time. The DBT-BIRAC support under Mission Covid Suraksha aims to meet the Covid-19 vaccine requirement of our country. I congratulate the team for the efforts put in for this achievement.”

15-May-2021: Government Supports Augmentation of Manufacturing Capacity for COVAXIN production under Mission COVID Suraksha

Under Atmanirbhar Bharat 3.0 Mission COVID Suraksha was announced by the Government of India, to accelerate the development and production of Indigenous COVID Vaccines. This is being implemented by Department of Biotechnology, Govt. of India at Biotechnology Industry Research Assistance Council (BIRAC), New Delhi.

To augment the capacity of Indigenous production of Covaxin under the Mission, the Department of Biotechnology, Government of India in April, 2021 provided financial support as Grant to vaccine manufacturing facilities for enhanced production capacities, which is expected to reach more than 10 crore doses per month by September, 2021.

As a part of this augmentation plan, capacities of Bharat Biotech Limited, Hyderabad as well as other public sector manufactures are being upgraded with required infrastructure and technology. Financial support is being provided as grant from GoI to the tune of approx. Rs 65 Cr to Bharat Biotech’s new Bangalore facility which is being repurposed to increase the capacity of vaccine production.

The following three public sector companies are also being supported to increase the capacity of vaccine production.

  1. Haffkine Biopharmaceutical Corporation Ltd, Mumbai-a State PSE under State Govt of Maharashtra. Financial support of Rs. 65 crores as grant from GoI is being provided for this facility to make it ready for manufacturing. The facility will have a capacity of 20 million doses per month, once functional.
  2. Indian Immunologicals Limited (IIL), Hyderabad –A facility under National Dairy Development Board is being provided a grant of Rs. 60 crore and
  3. Bharat Immunologicals and Biologicals Limited (BIBCOL), Bulandshahr a CPSE under Department of Biotechnology, Government of India is being supported with a grant of Rs. 30 crores to prepare their facility to provide 10-15 million doses per month.

Further, Gujarat Biotechnology Research Centre, Department of Science and Technology Govt. of Gujarat along with Hester Biosciences and OmniBRx has also firmed up its discussions with Bharat Biotech to scale up the COVAXIN technology and to produce minimum 20 million doses per month. Technology transfer agreement have been finalized with all manufacturers.

About DBT: The Department of Biotechnology (DBT), under the Ministry of Science & Technology, promotes the use and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment and industry. It is focused on attaining new heights in biotechnology research, shaping biotechnology into a premier precision tool of the future for creation of wealth and ensuring social justice – specially for the welfare of the poor. www.dbtindia.gov.in

About BIRAC: Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, set up by Department of Biotechnology (DBT), Government of India as an Interface Agency to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.www.birac.nic.in

16-Apr-2021: Augmentation of Manufacturing Capacity for COVAXIN production under Mission COVID Suraksha

Under Atmanirbhar Bharat 3.0 Mission COVID Suraksha was announced by the Government of India, to accelerate the development and production of Indigenous COVID Vaccines. This is being implemented by Department of Biotechnology Govt of India.

Under the Mission the Department of Biotechnology Govt of India is providing financial support as Grant to vaccine manufacturing facilities for enhanced production capacities. The current production capacity of indigenously developed Covaxin vaccine will be doubled by May-June 2021 and then increased nearly 6-7 fold by July - August 2021 i.e. increasing the production from 1 crore vaccine doses in April, 2021 to 6-7 crore vaccine dose/month in July – August. It is expected to reach nearly 10 crore doses per month by Sep 2021.

Few weeks back, Inter-ministerial teams had visited the sites of 2 main vaccine manufacturers in India to get their inputs on how production can be ramped up. In this period, there have been extensive reviews and feasibility studies on the plans being discussed with vaccine manufacturers.

As a part this augmentation plan, capacities of Bharat Biotech Limited, Hyderabad as well as other public sector manufactures are being upgraded with required infrastructure and technology. Financial support is being provided as grant from GoI to the tune of appx Rs 65 Cr to Bharat Biotech’s new Bangalore facility which is being repurposed to increase the capacity of vaccine production.

3 public sectors companies are also being supported to increase the capacity of vaccine production.

Haffkine Biopharmaceutical Corporation Ltd , Mumbai –a State PSE under State Govt of Maharashtra. Financial support as grant from GoI to the tune of appx Rs 65 Cr will be provided for this facility to be made ready for manufacturing. The Haffkine Biopharmaceuticals Ltd had asked for around 12 months to complete this task. However, the Central government has asked them to expedite and complete the task urgently within 6 months. The facility will have a capacity of 20 million dozes per month, once functional.

Indian Immunologicals Limited (IIL), Hyderabad –A facility under National Dairy Development Board and Bharat Immunologicals and Biologicals Limited (BIBCOL) , Bulandshahr  a CPSE under Department of Biotechnology ,Govt of India will also be supported to prepare there facility to provide 10-15 million dozes per month by Aug - Sep 2021.