Clinical Trials Knowhows for Novel Vaccine Development

Vaccination, by saving millions of lives, is unquestionably one of the biggest triumphs in the history of medicine. Numerous efforts and substantial amount of research are focused on producing an efficacious and qualified vaccine for the current pandemic of COVID-19. Leading pharmaceutical companies have started promising clinical trials worldwide recruiting healthy human volunteers to contribute and become a partner in scientific discovery. The clinical trials process includes human studies for acceptable safety and reactogenicity of a potential vaccine in Phase I trial and ensuring the proof-of-concept of the vaccine in Phase II. The final step in clinical evaluation is Phase III trial intended to provide a conclusion needed for license and marketing approval. We, in this article, have tried to address the clinical trials and evaluation process required to define the safety profile, monitoring, licensing and approval of a new vaccine candidate.