Question

11. Outline the general stages of a development cycle of a vaccine.

Answer 1

According to CDC there are 6 general stages of development of a vaccine.

1.Exploratory : It's a research-intensive phase of the vaccine development process is designed to identify “natural or synthetic antigens that might help prevent or treat a disease or virus.

2.Pre-clinical : Here basically researchers in private industry use tissue-culture or cell-culture systems and animal testing to determine whether the candidate vaccine will produce immunity against the disease.

3.Clinical development : Here a sponsor, usually a private company, submits an application for an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) Once the proposal has been approved, the vaccine must pass three trial stages of human testing.

4.Regulatory review and approval : If a vaccine passes through all three phases of clinical development, the vaccine developer submits a Biologics License Application (BLA) to the FDA.

5.Manufacturing : Major drug manufacturers provide the infrastructure, personnel and equipment necessary to create mass quantities of vaccines.

6.Quality control : Vital step The approval and distribution is far from the end of the line. Vaccine is distributed and made public .