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This segment describes how vaccines are evaluated for safety before they are made available to the public.
In this video series, physicians at The Children's Hospital of Philadelphia explain how vaccines work and how they are made. The video also describes several vaccines and the diseases they prevent. Families share their stories of children affected by vaccine-preventable diseases.
Paul A. Offit, MD: Another question parents ask is, "How do we know vaccines are safe?" Vaccines are evaluated for safety in three ways: First, vaccines cannot be given to any child in the United States until they are first approved or licensed by the Food and Drug Administration. In order to be licensed, a vaccine must be evaluated in a laboratory and then in thousands and thousands of children over a period of many years. Because vaccines are intended for healthy children, they are held to the highest standards of safety.
Georges Peter, MD: The next step in the approval process for these vaccines is the recommendations. These recommendations are made by three different groups who work closely together. For more than 20 years I have worked with two of these groups. And I can tell you that when the doctors and public health professionals and scientists study and analyze the information, we ask three basic questions: First, does the vaccine work? In other words, does it prevent the disease? Secondly, is the vaccine safe? Third, do we have all the information we need to answer these questions of vaccine safety and effectiveness? But the guiding principle, the bottom line, is would we give this vaccine to our patients, our children, and our grandchildren? If the answer is "yes," then we recommend the vaccine.
Benjamin Schwartz, MD: Although vaccines are usually tested in tens of thousands of children before approval, that still may not be enough to detect very, very rare side effects. For that reason, we do something called post licensure monitoring. The Centers for Disease Control and the Food and Drug Administration regularly send out a reporting form to doctors and nurses, which they can use to report any health problems that they think might be caused by a vaccine. This is called the Vaccine Adverse Events Reporting System or VAERS. Parents also can report to VAERS. But VAERS and other studies are only two of the many ways by which the safety of vaccines is monitored.
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