๐ Topic 03 of 6 ยท Chapter 07 ยท Health Technology & Pharmaceuticals
Vaccine Development & Clinical Trials
Phases of clinical trials, cold chain, UIP, GAVI โ complete notes for UPSC & PSC exams.
๐ Phases of Vaccine Development
| Phase | Purpose | Participants | Duration |
|---|---|---|---|
| Preclinical | Lab and animal testing; safety and immune response | Animals (mice, monkeys) | 1-2 years |
| Phase I | Safety testing; dosage determination | 20-100 healthy volunteers | Several months |
| Phase II | Efficacy and side effects; immune response | Hundreds of volunteers | Several months to 2 years |
| Phase III | Large-scale efficacy and safety; compare with placebo | Thousands of volunteers | 1-4 years |
| Regulatory Approval | Review by drug regulator (CDSCO in India) | โ | Months |
| Phase IV | Post-market surveillance; long-term effects | General population | Ongoing |
๐ Universal Immunisation Programme (UIP)
- India’s national immunisation programme โ covers 12 vaccine-preventable diseases
- Vaccines: BCG (TB), OPV/IPV (Polio), DPT (Diphtheria, Pertussis, Tetanus), Hepatitis B, Hib, Pneumococcal, Rotavirus, Measles, Rubella, JE (Japanese Encephalitis), Typhoid
- Mission Indradhanush (2014) โ intensified immunisation drive; targets unvaccinated children
- India eradicated Polio in 2014 โ last case in 2011
- India eradicated Smallpox in 1977
๐ Cold Chain & GAVI
- Cold Chain โ system of refrigerated storage and transport to keep vaccines at 2-8ยฐC from manufacturer to patient
- India has one of the world’s largest cold chain networks
- GAVI (the Vaccine Alliance) โ provides vaccines to developing countries at affordable prices; founded 2000; India’s SII is major supplier
- COVAX โ GAVI’s COVID-19 vaccine initiative; India supplied vaccines to 95+ countries
โญ Key Facts:
โข Vaccine development: Preclinical โ Phase I (safety) โ Phase II (efficacy) โ Phase III (large-scale) โ Approval โ Phase IV (post-market)
โข UIP = Universal Immunisation Programme = 12 vaccine-preventable diseases
โข Mission Indradhanush (2014) = intensified immunisation
โข India eradicated Polio (2014) and Smallpox (1977)
โข GAVI = Vaccine Alliance = India’s SII is major supplier
โข Vaccine development: Preclinical โ Phase I (safety) โ Phase II (efficacy) โ Phase III (large-scale) โ Approval โ Phase IV (post-market)
โข UIP = Universal Immunisation Programme = 12 vaccine-preventable diseases
โข Mission Indradhanush (2014) = intensified immunisation
โข India eradicated Polio (2014) and Smallpox (1977)
โข GAVI = Vaccine Alliance = India’s SII is major supplier