Vaccine Research and Development
Recognizing the importance of vaccines as the most cost-effective health intervention for controlling infectious disease burden, the Department of Biotechnology (DBT) has made concerted efforts in the past three decades, towards strengthening vaccine research and development in India.
Key initiatives to support basic and translational research for strengthening vaccine science, that are currently under implementation, includethe (i) Indo – US Vaccine Action Programme (VAP), (ii) National Biopharma Mission (NBM) (iii) Ind-CEPI Missionand (iv) Mission COVID Suraksha.
DBT Supported Vaccine Portfolio
Indo-US Vaccine Action Programme (VAP)
The Indo-US Vaccine Action Programme (VAP), is an internationally recognized flagship programme of the Department of Biotechnology,beingimplemented jointly with the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), USA, since 1987.VAP is a unique bilateral programme with an aim to support novel and innovative vaccine related research, accelerated development of candidate vaccines for which earlier leads are available, research of basic & applied nature to improvise our current understanding of vaccine science to strengthen the scientific basis for future vaccine design and to strengthen vaccine development ecosystem.
The programme has demonstrated major achievements like the low-cost Rotavirus vaccine which became part of the Universal Immunization programme &has taken major strides towards development of vaccines for diseases like Malaria, Dengue, Tuberculosis and COVID-19.
Initiatives to Strengthen Vaccine R&D:The Indo-US Vaccine Action Programme has also initiated several bilateral programmes under its fold. The major Initiatives under the Indo-US VAP are described below:
- Candidate Vaccine Advisory Committee (CVAC):Established in 2016 under the aegis of Indo-U.S. Vaccine Action Program (VAP), the Candidate Vaccine Advisory Committee (CVAC) provides oversight to research and development activities for advancing vaccine candidates approaching readiness for clinical trials. The committee comprises of vaccine research and policy experts from India and U.S., as the members including key researchers for each of the candidate vaccines that come under consideration for VAP oversight. The CVAC endorses the candidates for one of four different levels of support.In its recent meetings,CVAC has reviewed vaccine candidates of Dengue (3), Tuberculosis (2), Chikungunya (1), RSV (1), Influenza (2) and COVID-19 (11) for further support towards their advancement in the development pipeline.
Regional Prospective Observational Research in Tuberculosis (RePORT) India Initiative : a uniquebilateral collaborative effort initiated in 2013, RePORT India Initiative was conceived to promote collaborative scientific efforts, within India and with US, to foster critically important TB research that will ultimately lead to enhanced interventions to tackle the TB challenge. The initiative aims of establishing a TB consortium with PAN- India representation involving long term longitudinal cohorts of TB patients in India to strengthen tuberculosis research. RePORT India was the first consortium to be established as part of the six current global RePORT International networks of TB consortia across the world.
The broad areas of research currently being undertaken include:
- Biomarkers for TB diagnosis and prognosis
- Understanding the impact of TB on DM
- Developing and validating TB diagnostics
- Clinical development of VPM1002, as a potential vaccine candidate for Prevention of TB Recurrence
- Understanding long-term outcomes of TB
- Indo-US human immunology programme jointly with Human Immunology Project Consortium (HIPC)– The Human Immunology Project Consortium (HIPC) program was established in 2010 by NIAID to generate molecular signatures of human immune responses triggered by vaccines, adjuvants or infectious pathogens; and to develop new tools/analytical approaches for the study of human immunology. Shortly after, Indian immunologists expressed interest in conducting human immune phenotyping studies in their cohorts. This interest evolved into creation of Indo-U.S. Bilateral Collaborative Research Grants on Human Phenotyping and Infectious Diseases. The programme is designed to support research efforts as depicted below:
The goal of this funding program is to promote collaborative research between Indian and U.S.-based HIPC investigators to conduct human phenotyping in the context of infectious disease or vaccines of public health importance to both India and US. DBT and NIAID have sponsored two funding opportunities under this collaboration. In the first phase of the programme, initiated in 2013, DBT and NIAID jointly supported five projects, which were active from 2014 through 2016. The projects yielded commendable progress as evinced from the high quality publications that were generated. Taking cognizance of the same, the second phase of DBT-NIAID joint funding support was initiated in 2018/early 2019, as part of which, five projects are currently being supported. The projects are focussed on understanding diverse aspects of human immune mechanisms such as (i) exploring immune responses of Indian infants vaccinated with Typbar-TCV using a systems biological approach, (ii) determining the dynamics of B cell responses in dengue patients from India with and without severe disease in primary versus secondary infections, (iii) identifying the ideal Tfh (follicular T helper cell) subset and its positive attributes in long-term protective immunity against Japanese encephalitis virus infection or vaccination, (iv) understand the immune mechanisms that characterize HBV vaccine efficacy in neonates/infants born to HBV+ mothers, using a multi-omic strategy and (v) identifying differences in immune signatures of BCG Vaccination at birth and revaccination in young adulthood using state-of-the-art molecular techniques.
- India-U.S. Collaborative Research Grants on Vaccine Adjuvant Development- In August 2019, DBT issued a joint funding opportunity announcement with NIAID for collaborative adjuvant research projects to bring together researchers in India and the US. Under the initiative, 4 projects are being supported presently, for developing novel adjuvants for Mtb, RSV, Flaviviruses, and Foot-and-Mouth Disease.
- Initiative on Bioethics under Indo-US VAP
Noting the importance of bioethics in the successful conduct of clinical research, the Indo-US VAP Joint Working Group recommended the implementation of a new Initiative to strengthen capacities in biomedical research ethics under the auspices of Indo-US VAP. DBT along with the Department of Bioethics of the NIH Clinical Center is supporting the strengthening clinical research ethics competencies in India. Under this collaboration, the National Biopharma Mission had organized a series of 4 webinars on Clinical Research Ethics:
- Scientific and Ethical Standards of Clinical Research in Public Health Emergencies.
- Navigating Ethical Issues in Large Community based Vaccine field Trials
- Challenges in Conducting Human Challenge Studies: Policy Perspectives from India and United States
- Ethical Perspectives in Planning and Conducting Clinical Trials for Cell and gene Therapies.
The webinars were attended bymore than 1900 attendees The implementation of a Fellowship programme is under consideration.
The Department is also implementing three major mission programmes to support Vaccine Research & Development. These programmes have been critical in strengthening the end-to-end vaccine development ecosystem providing a strong foundation for development of effective interventions in combating the COVID-19 pandemic. The missions are as under:
The National Biopharma Mission (NBM) is an Industry-Academia collaborative Mission, for accelerating early development of biopharmaceuticals. The mission titled “Innovate in India (i3) – Empowering biotech entrepreneurs & accelerating inclusive innovation” was approved by the Cabinet Committee on Economic Affairs in May 2017. This ambitious Mission of the Department of Biotechnology (DBT) is being funded by the Government of India at a total project cost of Rs 1500 Crores for five years on a 50% cost sharing basis via World Bank loan and is being implemented at the Biotechnology Industry Research Assistance Council (BIRAC) - a Public Sector Undertaking of DBT. The Mission is designed in alignment with the key components of the National Missions such as “Make in India” and “Start-up India” and also aims to take forward the commitments made by DBT in the National Biotechnology Development Strategy. The availability of affordable and accessible vaccines in India is one of the priority areas of the Mission and support is being extended for vaccine candidates at different stages of development. More information on the Mission may be accessed at: https://birac.nic.in/nationalbiopharmamission.php.
The Department of Biotechnology is supporting the implementation of the Ind-CEPI Mission aligned with the global initiative of the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI is an innovative global partnership between public, private, philanthropic, and civil society organizations. CEPI’s endeavour is to accelerate the development of vaccines against emerging infectious diseases caused by viruses such as Ebola, Zika, Chikungunya, Nipah and SARS viruses, in alignment with the priority list established by the WHO in its “R&D Blueprint for action to prevent epidemics”.
The Ind-CEPI Mission was approved on March 27, 2019, for a period of five years and is part of a broader Initiative called the ‘Atal Jai Anusandhan Biotech Mission - Undertaking Nationally Relevant Technology Innovation (UNaTI)’, which is expected to transform Health, Agriculture and Energy sectors during the next 5 years. The Ind-CEPI Mission aims to support vaccine development for potential outbreak threats and enhance inter-ministerial co-ordination for rapid vaccine development. More information on the Mission may be accessed at: https://birac.nic.in/desc_new.php?id=635.
In the wake of the COVID-19 pandemic, the Department of Biotechnology is leading the implementation of ‘Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission’. The mission was announced as part of the third stimulus package, Atmanirbhar Bharat 3.0, for promoting research and development of Indian COVID-19 vaccines. The mission is being implemented by Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking (PSU) of DBT, at a total cost of Rs. 900 Cr. for 12 months. The Mission has been intended to be a National Mission with a focus on bringing to the citizens of the country a safe, efficacious, affordable and accessible COVID-19 Vaccine, at the earliest with a focus on Atma Nirbhar Bharat. The goal of the Mission is to accelerate the development of at least 5-6 COVID-19 vaccine candidates and ensure that some of these are brought closer to licensure and introduction in the market for consideration of regulatory authorities and for introduction in public health systems.
Contacts Concerned Officer for more information
|Programme Head||Dr Alka Sharma, Scientist G|
|Programme Officer||Dr Jyoti Malik Logani, Scientist E|
|Attached Officer||Dr. Kamakshi Chaithri P, Scientist C|