π Topic 03 of 6 Β· Chapter 07 Β· Health Technology & Pharmaceuticals
Vaccine Development & Clinical Trials
Phases of clinical trials, cold chain, UIP, GAVI β complete notes for UPSC & PSC exams.
π 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) | β | Months |
| Phase IV | Post-market surveillance; long-term effects | General population | Ongoing |
π Universal Immunisation Programme (UIP)
- India’s national immunisation programme β 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) β intensified immunisation drive; targets unvaccinated children
- India eradicated Polio in 2014 β last case in 2011
- India eradicated Smallpox in 1977
π Cold Chain & GAVI
- Cold Chain β system of refrigerated storage and transport to keep vaccines at 2-8Β°C from manufacturer to patient
- India has one of the world’s largest cold chain networks
- GAVI (the Vaccine Alliance) β provides vaccines to developing countries at affordable prices; founded 2000; India’s SII is major supplier
- COVAX β GAVI’s COVID-19 vaccine initiative; India supplied vaccines to 95+ countries
β Key Facts:
β’ Vaccine development: Preclinical β Phase I (safety) β Phase II (efficacy) β Phase III (large-scale) β Approval β Phase IV (post-market)
β’ UIP = Universal Immunisation Programme = 12 vaccine-preventable diseases
β’ Mission Indradhanush (2014) = intensified immunisation
β’ India eradicated Polio (2014) and Smallpox (1977)
β’ GAVI = Vaccine Alliance = India’s SII is major supplier
β’ Vaccine development: Preclinical β Phase I (safety) β Phase II (efficacy) β Phase III (large-scale) β Approval β Phase IV (post-market)
β’ UIP = Universal Immunisation Programme = 12 vaccine-preventable diseases
β’ Mission Indradhanush (2014) = intensified immunisation
β’ India eradicated Polio (2014) and Smallpox (1977)
β’ GAVI = Vaccine Alliance = India’s SII is major supplier