The Indo-US Vaccine Action Programme (VAP) is a bilateral program of the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India; and the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), under implementation since July 1987. It has been recognized internationally and considered as a model bilateral programme in biomedical research. The oversight to the programme is provided by the Joint Working Group comprising of the scientists and policy makers from both sides that meets annually. The programme was renewed for another term of five years till April, 2022 through formal signing of the VAP Joint Statement in April 2017, between Secretary, DBT and Director, NIAID, NIH.
One of the major achievements under VAP is the development of ROTAVIRUS VACCINE (ROTAVAC®). This is the first indigenous rotavirus vaccine, developed from an Indian strain by an Indian company, and tested by Indian investigators in an effort led by the Indian government and supported by several national and global partners. The vaccine has been developed by a unique social innovation of public-private sectors along with institutional collaboration. The programme was initially supported at AIIMS, New Delhi in collaboration with CDC, Atlanta, USA. The vaccine is manufactured in India by M/s Bharat Biotech International Limited, Hyderabad under cGMP conditions. The company announced a price of US$ 1.00/dose (or approximately INR 54/dose). ROTAVAC® is a more affordable alternative to the rotavirus vaccines already on the market. The vaccine is commercialized and based on the recommendations of NTAGI; ROTAVAC® was introduced into our national immunization programme during 2016, with 35 million doses delivered till date.
The ROTAVAC®) has been prequalified by WHO that paves the way for health and humanitarian organizations such as UNICEF, GAVI and Pan-American Health Organization to procure it for public health vaccination programmes across the world. It is a great success to Make in India. Rota vaccine is a tremendous boost. The development of ROTAVAC is also an evidence of a growing vaccine development sector in India, a country previously known for remaking existing drugs in generic form.
DBT has also been supporting development of novel Dengue vaccine focusing on a tetravalent candidate suitable for all population including affected and non-affected pediatric adult and travelers at International Centre for Genetic Engineering & Biotechnology (ICGEB), New Delhi. Several candidates for Dengue are at advance stage of clinical trials, however, the development of a safe, affordable and efficacious dengue vaccine still faces major challenge. Under the study at ICGEB, team has developed a tetravalent Dengue Subunit VLP (DSV4) based vaccine candidate, expressed using the methylotrophic yeast Pichia pastoris. The ICGEB has conducted pre-clinical studies on Dengue over the past seven years. With collaborative efforts ICGEB jointly with Sunpharma is developing an affordable and improved Dengue vaccine of significant health importance to India and rest of the world.
In addition to this Department also supported Malaria vaccine development programme at International Centre for Genetic Engineering & Biotechnology. ICGEB, New Delhi along with its translational research partner “Multi Vaccines Development Program” earlier known as “Malaria Vaccine Development Program” (a not-for-profit society formed and registered under the Societies Registration Act) has advanced the development of blood-stage vaccines for P. falciparum and P. vivax malaria over the last decade. Funding support through Vaccine Grand Challenge Program of Department of Biotechnology, Biotechnology Industry Research Assistance Council (BIRAC) and multiple international agencies including Malaria Vaccine Initiative (MVI), PATH and European Vaccine Initiative (EVI) has been received. These recombinant protein-based adjuvant Malaria vaccines advanced through the translational development pathway of GMP production, pre-clinical immunogenicity testing, GLP compliant toxicity testing and Phase I trial after receiving all necessary regulatory approvals. All these translational development activities have been done with Indian partners or collaborators or through an out-sourced model. JAIVAC-1 (P. falciparum vaccine candidate), JAIVAC-2 (Second generation P. falciparum vaccine candidate, PvDBPII (P. vivax vaccine candidate) the three vaccine candidates which have undergone development beyond lab.
R&D is also a key pillar of the global response to TB. With this global uptake in R&D efforts, the goal to end TB is well within sight. DBT has partnered in the multi-organizational collaborative effort designed to advance regional basic and clinical tuberculosis (TB) science in India, strengthen TB research capacity and infrastructure, and foster research collaboration within India and with other countries through RePORT Initiative.
During its 30 years of implementation, VAP has evoked considerable enthusiasm in the biomedical scientific community in both the countries. A good number of Indian scientists’ especially young scientists and clinicians have been trained in leading institutions in USA and considerable infrastructure and other facilities have been established under the programme in the collaborating Indian institutions for advanced R&D. A number of research leads for potential diagnostics and vaccines have also been obtained. The collaborative programme has attracted good amount of funding for major vaccine projects such as Rotaviral Diarrhoea, Malaria, dengue and tuberculosis from International Vaccine Research funding organizations.
Inputs from : Dr. Jyoti M Logani, Scientist ‘E’, Department of Biotechnology