20-Aug-2021: DBT-BIRAC supported ZyCoV-D developed by Zydus Cadila Receives Emergency Use Authorization
Zydus Cadila has received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today i.e. 20/08/2021, the world’s first and India’s indigenously developed DNA based vaccine for COVID-19 to be administered in humans including Children and adults 12 years and above. Developed in partnership with the Department of Biotechnology, Government of India under the ‘Mission COVID Suraksha’ and implemented by BIRAC, ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for Preclinical studies, Phase I and Phase II Clinical Trials and under the Mission COVID Suraksha for Phase III Clinical Trial. This 3 dose vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring.
Interim results from Phase-III Clinical Trials, in over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far in India for COVID-19. This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).
Vaccine Technology Centre (VTC), vaccine research centre of the Zydus group, Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT and Interactive Research School for Health Affairs (IRSHA), Pune, GCLP Lab set up under the Department of Biotechnology - National Biopharma Mission (NBM) also played a vital role in this success story.
Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said that “It is a matter of great pride that today we have the EUA for the world’s first DNA COVID-19 vaccine ZyCoV-D by Zydus developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha. The Indian Vaccine Mission COVID Suraksha was launched under the Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is aimed at the development of safe and efficacious COVID-19 vaccines for public health. 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”
Speaking on the development, Chairman of the Zydus Group, Mr. Pankaj R. Patel said, “We are extremely happy that our efforts to put out a safe, well tolerated and efficacious vaccine to fight COVID-19 has become a reality with ZyCoV-D. To create the world’s first DNA vaccine at such a crucial juncture and despite all the challenges, is a tribute to the Indian research scientists and their spirit of innovation. I’d like to thank the Department of Biotechnology, Government of India for their support in this mission of Atma Nirbhar Bharat and Indian Vaccine Mission COVID Suraksha.”
About DBT: The Department of Biotechnology (DBT), under the Ministry of Science and Technology, promotes and improves biotechnology development in India through its development and implementation in agriculture, healthcare, animal sciences, the environment, and industry.
About BIRAC: A non-for-profit Public Sector Enterprise, Biotechnology Industry Research Assistance Council (BIRAC), has been set up by the Department of Biotechnology (DBT), Government of India, which acts as an interface agency to enhance and encourage the evolving biotechnology industry to implement strategic research and development activities in regards to the product development needs of the Nation.
4-Jun-2021: DBT-NII Receives Trademark for India’s First Indigenous Tumour Antigen SPAG9
Cancer kills8.51 lakh people in India every year (International Agency for Research on Cancer, 2020,Globocan). As per World Health Organization (WHO), one in 10 Indians will develop cancer during their lifetime, and one in 15 will die of cancer. Therefore, it is all the more critical to make extraordinary breakthroughs and innovations for this deadly disease. To successfully implement innovation newer modalities for cancer treatment, researchers at the New Delhi-based National Institute of Immunology (NII), an Autonomous Institute of Department of Biotechnology (DBT),and clinicians at Cancer Institute, Adyar, Chennai have been working together to translate new scientific discoveries into improved care for cancer patients. Over the past two decades, this team has been engaged in translating breakthrough that promises to add a highly potent weapon to the armoury against cancer especially employing targeted cancer Immunotherapy. India's first indigenous tumour antigen SPAG9 was discovered by Dr Anil Suri in 1998who is heading the Cancer Research Program at NII. In a recent development, theSPAG9 antigen has received the trademark ASPAGNIITM. Currently, ASPAGNIITM is being used in dendritic cell (DC) based immunotherapy in cervical, ovarian cancer and will also be used in breast cancer.
Immunotherapy is a new approach that exploits the body’s inner capability to put up a fight against cancer. With this approach, either the immune system is given a boost, or the T cells are “trained’’ to identify recalcitrant cancer cells and kill them. In this personalised intervention, those patients expressing SPAG9 protein can be treated with DC-based vaccine approach. In DC-based vaccine, patient’s cells called monocytes from their blood are collected and modified into what are called dendritic cells. These dendritic cells are primed with ASPAGNIITM and are injected back to the patient to help the ‘fighter’ cells, or T-cells, in the body to kill the cancer cells. DC-based immunotherapy is safe, affordable and can promote antitumor immune responses and prolonged survival of cancer patients.
The Department of Biotechnology has funded Cancer Research Program. Dr Anil Suri said, “we are thankful to DBT for giving us the platform and the necessary support to work all these years. ”Dr Suri’s collaborator Dr. T Rajkumar, MD, DM, head of molecular oncology, is conducting clinical trials in cervical cancer patients at Cancer Institute, Adyar, Chennai. Dr T Rajkumar has been funded by the Department of Science and Technology, Government of India, to establish the Centre for Cancer Immunotherapy and to undertake these cancer trials. Also, Dr Suri and Dr T Rajkumar have been funded to undertake clinical trials using Dendritic cell-based vaccine in 75 recurrent/metastatic ovarian cancer stage IV patients employing ASPAGNIITM funded by the India Council of Medical Research (ICMR). Further with the funding support of the Department of Biotechnology in future, employing ASPAGNIITM, a phase 2 randomised controlled clinical trial to evaluate the role of metronomic chemotherapy and dendritic cell vaccine in recurrent hormone receptor-negative breast cancer will also be initiated at Cancer Institute, Adyar.
The ASPAGNIITM is a true example of translational cancer research and the Atmanirbhar Bharat spirit. It will eventually be helpful to patients in India and the world. This will be a real morale boost in affordable, personalised, and indigenous products for cancer treatment.
28-Dec-2020: Dr Harsh Vardhan inaugurates Country’s First Pneumococcal Conjugate Vaccine
Dr Harsh Vardhan, Union Minister for Health and Family Welfare today inaugurated India’s first pneumococcal conjugate vaccine (PCV). The vaccine “Pneumosil” has been developed by the Serum Institute of India Private Limited (SIIPL) in collaboration with partners like the Bill and Melinda Gates Foundation.
Recognizing SIIPL as the world’s largest manufacturer of vaccines by number of doses and its contribution to India’s economy, Dr. Harsh Vardhan remarked that Serum Institute’s Vaccines are used in 170 countries and every third child in the world is immunized with the manufacturer’s Vaccine. He reminded the audience that SIIPL developed and got license of first indigenous Pneumococcal Conjugate Vaccine (PCV) from Government of India during COVID-19 pandemic lock-down in line with Prime Minister Sh. Narendra Modi ji’s vision of ‘AatmaNirbhar Bharat’. He also mentioned about the extraordinary efforts of Ministry of Health & Family Welfare in this endeavour to make India self-reliant in PCV.
Detailing the achievements of SIIPL in tailoring a vaccine for India’s needs, Dr. Harsh Vardhan said, “Serum Institute’s first Indigenous Pneumococcal Conjugate Vaccine will be available in the market under brand name “Pneumosil” at an affordable price in single dose (vial and pre-filled syringe) and Multidose (vial) presentations. Pneumosil has been extensively evaluated in 5 randomized controlled clinical trials and has demonstrated comparable safety and immunogenicity against licensed pneumococcal vaccines across diverse populations of India and Africa, where Pneumosil was administered to adults, toddlers and infants using different vaccination schedules.” “During clinical trials, Pneumosil was found to be safe and effective in the prevention of Pneumonia disease and based on which Pneumosil has been licensed by Drugs Controller General (India) in July 2020 after approval from Subject Expert Committee (SEC),” he added.
Speaking on the Prime Minister’s commitment of AatmaNirbhar Bharat and his vision of ‘Making In India for the World’, Dr. Harsh Vardhan noted, “Pneumosil is an example of India's capability in Research & Development & manufacturing high end sophisticated Vaccines. In fact, it is matter of pride for our country for this historical milestone during COVID-19 Pandemic because till now we are fully dependent on Pneumococcal Conjugate Vaccine manufactured by Foreign Manufacturers which are available at very high prices.” He took the occasion to remind the audience that Pneumonia is the single largest infectious cause of death among children under five years of age worldwide, accounting for nearly 10 lakhs deaths globally.
Congratulating the country’s scientific and medical fraternity, the minister said, “I am sure that the team of Serum Institute of India and others in the entire scientific and medical community will continue their endeavour to develop many more life-saving vaccines in future.”
Dr. Manohar Agnani, Additional Secretary (MoHFW) and other senior officials of the Ministry were present at the event.
Dr. Cyrus Poonawalla, Chairman, Poonawalla Group of Industries and Founder, Serum Institute of India Private Limited (SIIPL), Shri Adar Poonawalla, Chief Executive Officer, SIIPL were also present.
13-May-2017: Pneumococcal Conjugate Vaccine(PCV) to be part of immunisation drive
India rolls out the long-awaited anti-pneumonia vaccine as part of the government’s Universal Immunisation Programme (UIP). The vaccine will protect children against severe forms of pneumococcal disease, such as pneumonia and meningitis.
The three-dose pneumococcal conjugate vaccine (PCV) will be rolled out in Mandi, Himachal Pradesh, six districts of Uttar Pradesh and 17 districts of Bihar as a part of the first phase. The vaccine will give protection against 13 types of pneumococcal bacteria which cause pneumonia disease.