What is the Safety Testing Process for Vaccines?


Before you ever receive a vaccine from your doctor, the vaccine must first be approved by the U.S. Food and Drug Administration (FDA). As part of the approval process, the FDA analyzes scientific studies of clinical trials regarding the safety and effectiveness of the particular vaccine. The FDA also performs on-site inspections of the facilities where the vaccines are manufactured.


The clinical trials of vaccines under development involve three phases. The first phase involves giving the vaccine to a small number of healthy volunteers. If there are no serious side effects from the vaccine, phase two of the clinical trial involves giving the vaccine to several hundred volunteers. Lastly, in the third phase of the clinical trial, thousands of volunteers are involved to better assess the impact, safety, and effectiveness of the vaccine on a larger cross section of patients.

Once vaccines are approved for use, the FDA initially provides close monitoring of the vaccinations to determine whether there may be side effects from the vaccine that were not readily apparent in the smaller clinical trials. Negative reactions to vaccines are monitored through the Vaccine Adverse Event Reporting System (VAERS), a nationwide system which collects reports from negative reactions to vaccines.

It’s important that if you or a loved one experience a negative reaction to a vaccine that you ensure your doctor submits a Vaccine Adverse Event Report to VAERS. The reports are often important to making sure you can recover compensation for a vaccination injury under the National Vaccine Injury Compensation Program.

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