From test tubes to clinical use

There are five key stages of vaccine development: Exploratory, pre-clinical, clinical development or human tests, regulatory review and approval, and manufacturing

Clinical development

PHASE I: Small groups of people receive the trial vaccine PHASE II: For people who have characteristics similar to those who are target of new vaccine PHASE III: Vaccine given to thousands of people to test for efficacy and safety

Indian vaccines in the works Diarrhoea 100,000 children fell victim to this disease in 2015

ROTAVAC, DEVELOPER: Bharat Biotech Status: Already in the market. Government placed orders for doses

ROTASIIL, DEVELOPER: Serum Institute of India in collaboration with PATH, an international non-profit

Status: Licensed by the government, applied for prequalification from the WHO. The government seeks to incorporate it in the universal immunisation programme

Dengue 245 people in India died of this vector-borne disease in 2016

a) DEVELOPER: Technology transferred from International Centre for Genetic Engineering and Biotechnology (ICGEB) to Sun Pharmaceutical Industries Limited in Mumbai Status: Ready for clinical development b) DEVELOPER: SERUM Institute, Pune Stage: Pre-clinical animal trials

Malaria 245 deaths in 2016 were due to this disease

a) DEVELOPER: Malaria Vaccine Development Programme (MVDP), a consortium of DBT, ICGEB, Multi Vaccine Initiative (MVI), PATH, European Vaccine Initiative (earlier EMVI) and WHO-TDR. Status: Phase 1 clinical trials conducted, analysis on

b) DEVELOPER: Indian Institute of Science, Bengaluru

Status: Pre-clinical animal trials

Chikungunya 62,000 suspected cases in 2016. Diagnosis is not proper

DEVELOPER: Bharat Biotech Status: Completed pre-clinical animal trials, ready for phase-1 clinical trials

AIDS 62,000 persons were killed in 2016

DEVELOPER: AIIMS, Indian Institute of Science in Bengaluru, Translational Health Science and Technology Institute in Faridabad, YR Gaitonde Centre for AIDS Research and Education in Chennai, National Brain Research Centre in Manesar, and International AIDS Vaccine initiative

Status: Exploratory studies