Q. How are vaccines tested to make sure they're safe?

Baby Article

Vaccines are researched extensively for an average of 15 years before being approved for use.

A pharmaceutical company conducts medical research trials in a series of stages. Once safety is proven, the vaccine is tested in several thousand volunteers to make sure the vaccine actually works. These volunteers are followed for at least one year to be sure that no serious side effects occur.

Nothing in this world is 100% foolproof, including vaccine science. But the research trials that occur before licensing are very rigid. If you think there are a lot of vaccines on the market, imagine how many didn’t make it through the research phase of development.

The Food and Drug Administration (FDA) governs this whole process. The FDA is the watchdog for any medication that is sold over-the-counter or by prescription. There are extremely high standards that must be met before any product is allowed for human use.

After a vaccine is approved for use, long-term follow-up studies are done to assess for side effects, adverse reactions, and potency over a lifetime.

Reality Check

Given the FDA’s mixed track record, you may be skeptical about trusting the government when it comes to vaccine safety. But in truth, the system is in place to protect consumers. Although conspiracy theorists might disagree, the FDA really is on our side.

To improve drug and vaccine safety, the Institute of Medicine has called for an overhaul of how the FDA works—in the future, the FDA will do more ongoing safety reviews of medicines and make all clinical study results public. This should help boost public confidence in the FDA and vaccine safety.