Vaccine development and distribution is not as easy as it sounds. It is a very complicated and time-consuming process. Depending upon what researchers are tying to accomplish, it can take decades to bring a vaccine to market. When it comes to vaccine development, public as well as private involvement is required.
Well, we are living in the 21st century where scientists follow a standardized process to develop, test, and regulate vaccines. But you might be surprised to know that this process was developed in the 20th century.
Many vaccines have been developed over the prior 100 years. Vaccines have been used to help manage the plague, rabies, smallpox, typhoid, cholera, and many more. It was in 1902 when the U.S. Congress passed a new regulation. It was about the selling serums, viruses, analogous products, and toxins. Later, it was considered as the Biologics Control Act. It was the first attempt by the U.S. government to keep the quality of drugs under control. There was a reason behind the emergence of this law. It was inextricably associated with the 1901 contamination event that happened in St. Louis. The Hygienic Laboratory had been built under this law in order to supervise the production of biological drugs. Later, it became the National Institutes of Health.
As per the United States Public Service Act, the federal government will have the authority to issue a license for biological products. It also included vaccines. The Division of Biological Standards had been developed after the poliovirus accident in 1954. It was known as DBS, but, now, it is renamed as the Bureau of Biologics. The Bureau of Biologics is an inextricable part of the Food and Drug Administration.
Stages of Vaccine Development
When it comes to vaccine development, there are several stages that scientists have to follow. These are as follows:
Laboratory and Animal Studies
This stage consists of the following steps:
- Exploratory stage.
- Pre-clinical stage.
- IND application.
Clinical Studies With Human Subjects
It is the second step where scientists have to follow the below-mentioned steps:
- Phase I vaccine trial.
- Phase II vaccine trial.
- Phase III vaccine trial.
Post-Licensure Monitoring of Vaccine
Here, phase IV trials have been done. It is a kind of optional study and it can be done after the release of the vaccine.
After that, the vaccine Adverse Event Reporting System established by the FDA and CDC study the vaccine to find out the adverse events inextricably associated with the vaccine.