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Vaccine clinical trials, a type of clinical research study, are medical studies that involve people. This is a process of evaluating the safety, immunogenicity, and protective efficacy in humans of a novel vaccine candidate before it can be licensed for use.
Clinical trials are carefully designed, reviewed, and completed, and need to be approved by the Food and Drug Administration (FDA) before they can start. People who meet the inclusion criteria can take part in clinical trials.
Vaccine development is a lengthy and a rigorous process.
Before a vaccine candidate is even tested among people, it has to pass the preclinical stage of development first where it is tested on animals to see if it will cause an immune response.
The clinical development is divided into three phases:
For phase 1, the vaccine is tested in small groups of people to assess its safety. The coverage is expanded in Phase 2 to assess the efficacy, right dosage, and ensure that the desired effects are achieved. Phase 3 covers a larger group of people to confirm its efficacy and safety when compared to other treatments.
This whole process usually takes years to complete.
- Published: 09 February 2021