Remember a few days ago when we talked about the organizations involved in vaccine use and safety? Ya know, the World Health Organization (WHO), the Center for Disease Control (CDC), and the American Academy of Pediatrics (AAP)? Well, there is one other organization that is specifically involved in making sure that vaccines are safe and effective.
The Food and Drug Administration (FDA) is a government organization that is responsible for approving the use of all foods and medications in the United States. There is a three-step process for a new medication (or vaccine) to be approved for use. These “clinical trials” happen in three phases, an a medication can only move on to the next phase if it is considered safe
- 20-100 volunteers. First stage in finding out whether the medication is safe, whether it works, and if there are serious side effects
- 100s of volunteers. Once a vaccine passes the first phase, researchers as for more people to try it out. In phase 2, the researchers are looking for the most common side effect of the medication (because almost every medication has some type of side effect). They are also looking to see how the volunteer’s immune systems are responding to the medication (or vaccine) dose.
- 100s-1,000s of volunteers. For the last phase, the researchers want an even BIGGER group of people. This is the final check to see if the medication (or vaccine) is safe and effective, what side effects people might have, and what the difference is between people who get the medication (or vaccine) and people who don’t.
Only when a medication (or vaccine) passes all of these tests can it be considered for use. The studies must show that the vaccine is safe and that it works (effective).
We said before that almost every medication has some type of side effect, so how do we decide if that side effect is worth it? That’s were we look at the RISK versus the BENEFIT. Sometimes the risk means the risk of getting the disease. And sometimes the risk means the risk of side effects.
The FDA has to determine that the BENEFIT outweighs any RISKs.
Every single time a manufacturer makes a batch (or “lot”) of a vaccine, they have to check that batch to make sure it is safe, pure, and potent. The FDA checks their work for safety and quality.
As we look at what happens when someone becomes sick with a vaccine preventable disease, you should be feeling pretty confident that vaccines are MUCH safer than the disease itself.