Stages of Vaccine Development

Bolstering the health development in India, delivering vaccines to ensure immunization is result of year’s extensive research and discovery. Minute amount of candidate vaccines progress through licensing, that adds to the Research and development cost of the immunization. Likewise, the various stages of developing vaccines help in determining its cost and the subsequent health schedule promoting global health. The stages of development can be broadly divided into two groups:

1. Pre-Clinical Development

It involves research that is carried out on animals and lab assays. The development process consists of the following steps:

• Identification and screening of the relevant antigens
• Conceptualizing and creating the vaccination concept
• Evaluation of the medicinal efficiency— testing on animals
• Manufacturing and formulation of vaccines as per the laid down standards

2. Clinical Development

The process involves testing the viability of the vaccines on humans. The clinical process of vaccine development covers four stages from initial testing trials on humans to induction and beyond. Clinical development is based on ethical principles consented from volunteers reiterating issues like vaccinum safety and its optimum efficacy. The four stages are elaborated as under:

• Phase 1 – Clinical trials to asses whether the developed vaccine is safe on humans and what sort of immune response it evokes.
• Phase 2 – trial to asses the efficacy of the drug against artificial infection or clinical disease. Aspects pertaining to vaccine safety, analysis of side-effects and efficiency optimization are addressed.
• Phase 3 – Vaccines are studied under larger lens, evaluating its performance amidst natural disease conditions, after testing the resilience of the vaccines, authorities regulate the license for market distribution.
• Phase 4 – Post-marketing surveillance, this stage strives to eliminate rare defects and long-term efficiency analysis of the vaccinum.

The Conclusion

Vaccines are developed, tested and distributed in a very similar manner like other drugs; the only difference in clinical trials is wide range of human subjects that needs to be taken care. The monitoring of the developed vaccines is closely examined by the Centers for Disease Control and FDA.