Vaccine Development

Developing a vaccine against several diseases remains a challenge. Vaccine Research & Development is very complex and costly because a vaccine is a biological product that is made from the living microorganisms. Therefore, its development cycle is quite different from the other pharmaceutical products. There are so many microbes that can cause disease, and the goal for a vaccine is to protect against all of them. There is limited understanding of how severe disease occurs and how the microbes interacts with the immune system. Several vaccine candidates are in clinical stages of development. The pre-clinical development stage is the first step to identify a vaccine candidate that determines a vaccine’s ultimate safety profile. Phase I trials is the stage where the researchers test the candidate vaccine for the first time in humans to evaluate its safety, safe dosage range, and vaccine-related side effects. Phase II trials is the stage where the candidate vaccine is administered to a larger group of people for the evaluation of its immunogenicity and safety. The goal of phase III is to conduct a large-scale safety and efficacy study on a relevant patient population. It is really very complex to market a new vaccine and once it has been marketed, pharmacovigilance activities take place in order to conduct a strict safety supervision of that vaccine.