Vaccine Development, Testing & Regulation

Vaccine development and testing includes basic research, clinical studies, side effects and adverse reactions, vaccines of the future, and the vaccine product approval process.

Clinical improvement is a three-stage process. Phase I included small groups of individuals get the trial immunization. In Phase II, the clinical examination is extended and immunization is given to individuals who have qualities, (for example, age and physical wellbeing) like those for whom the new antibody is directed. In Phase III, the immunization is given to a great many individuals and tried for adequacy and safety. Numerous immunizations experience Phase IV formal, continuous investigations after the antibody is endorsed and authorized.

The U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States.

The CDC and FDA established Vaccine Adverse Event Reporting System in 1990. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the CDC.


  • Basic Vaccinology
  • Vaccines discovery, development & formulation
  • Vaccine clinical trials
  • Vaccine Management & Quality Assurance
  • Vaccine Immunoinformatics
  • Therapeutic vaccination for auto immune diseases
  • Vaccine Research in Europe
  • Ebola outbreak

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