Vaccines, just like many other products in the United States, are subject to rigorous testing and approval procedures before they are administered. Because these processes are not widely understood, many populations are intimidated by receiving vaccination. Never fear, today we’ll be decimating all those fears as an antibody would a virus. Will there be a deal or no deal for vaccine production? Only stringent regulations may reveal.
Approval for the distribution of vaccinations starts at the level of development. According to the CDC, there are a few general stages of vaccine creation, one of which being clinical development.
Clinical Development
When vaccines are being investigated, there are several crucial phases.
First, a small group of people in initial trials will receive the vaccine. Eventually, if the first phase is deemed safe and successful, the study is expanded to a larger group of people who often share a certain trait (generally a group with the same age or physical health). Once this stage is cleared, it moves on to the third and final testing phase, where the vaccine is administered to thousands. As an additional cautionary measure, many vaccines also undergo a fourth phase of ongoing studies of the vaccine’s impacts even after the vaccination is approved and licensed.
During this entire process, vaccine developers may reference the World Health Organization’s numerous guidelines on vaccine research, ranging from considerations to make about vaccine policy to specific types of diseases (infectious, antimicrobial resistant, enteric).
Vaccine Approval
Finally, moving on to the approval process. As for many products consumed by the U.S., vaccines must undergo monitoring and regulation by the Food and Drug Administration’s Center for Biologics Evaluation and Research.
Like the process of development, the approval procedure involves several stages. First, the vaccine is investigated, given a pre-license to conduct clinical trials, followed by a Biologics License and an inspection of the developer’s facility. Finally, the FDA’s findings are presented to the Vaccines and Related Biological Products Advisory Committee to be formally approved on the basis of safety, effectiveness, and appropriate use.
Yet the FDA’s role doesn’t end there. Their commitment to ensuring the efficacy of vaccines extends beyond the approval process as they regularly monitor vaccine production and side effects.
In short, there is almost constant regulation and oversight over the creation of vaccines to ensure that they effectively keep our communities safe. So yes, we surely have a deal here.
Resources:
Comments