Vaccine trial

Subject: Science and tech

Context:

Phase 2 human clinical trials of the Oxford University-AstraZeneca vaccine candidate for Covid-19, manufactured by Serum Institute of India, will begin in the coming week.

Concept:

• The general stages of the development cycle of a vaccine are:
  • Exploratory stage
  • Pre-clinical stage
  • Clinical development
  • Regulatory review and approval
  • Manufacturing
  • Quality control
• Clinical development is a three-phase process.
• During Phase I, small groups of people receive the trial vaccine.
• In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
• In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
• In India, Central Drugs Standard Control Organisation gives approvals for clinical trials.