Vaccine Safety

Vaccines are the best way to prevent serious illness and death from many infectious diseases. The Food and Drug Administration (FDA) adheres to rigorous testing standards before licensing vaccines.

The FDA uses computers to predict how a new vaccine will work. Researchers then test the vaccine on animals. If the vaccine completes these tests successfully, the FDA allows it to be tested on people during clinical trials. People who participate in clinical trials understand the risks and choose to receive the vaccine. After reviewing clinical trial results and the proposed vaccine label, inspecting the plant where the vaccine will be made, and reviewing the vaccine production process, the FDA may decide to license the vaccine.

Once licensed, vaccines continue to be closely monitored through the national Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD) Project. Anyone can report a health problem to VAERS. Any problem with a vaccine may prompt further investigation by the Centers for Disease Control and Prevention and the Food and Drug Administration.

Leaders in the field of public health, such as the Centers for Disease Control and Prevention, the Public Health Service, and the nation's physicians (e.g., the American Academy of Pediatrics, the American Medical Association, and American Academy of Family Physicians continue to recommend vaccines for children, adolescents, and adults to prevent disease.

Trusted sources of information

People with questions or concerns about vaccine safety should contact their healthcare providers. Information found online should not replace the information given by a healthcare provider. However, there are several trusted organizations that parents and patients can turn to for additional information.