摘要：The National Immunization Program of the Centers for Disease Control and Prevention is responsible for controlling infectious diseases through vaccination, but the program also plays a key role in postlicensure vaccine safety assessment. The time has come to separate postlicensure vaccine safety assessment from vaccine risk management as recommended by the National Research Council of the National Academy of Sciences. The National Transportation Safety Board offers a useful model for developing an independent National Vaccine Safety Board that would have the authority to leverage resources and expertise of various government agencies, academia, and industry to oversee postlicensure vaccine safety investigations. Such a board would have been useful in recent vaccine safety concerns, and its independence from government programs would ensure optimal vaccine safety and enhance public confidence in vaccines. VACCINES SAVE THOUSANDS of lives every year, but may cause side effects (e.g., mild fever, localized reactions) and rare serious adverse events (e.g., anaphylaxis, vaccine-associated paralytic polio). Vaccines are held to a higher safety standard than other biologics because vaccines are given to healthy persons and are required for school attendance. 1 Most of the safety questions that arise almost every year about licensed vaccines—such as hypotheses about vaccines causing diabetes, multiple sclerosis, and other chronic diseases—prove to have little or no scientific basis. But new adverse events are discovered from postlicensure investigations such as intussusception following rhesus rotavirus vaccine 2 and Guillain–Barré syndrome associated with the 1976 swine influenza vaccine. 3, 4 Other concerns may indicate the need for changes in products or policy even when definitive data on causal associations may be absent, for example, removal of thimerosal from vaccines administered to infants and children because of theoretical risks. 5, 6 The debate about the reintroduction of smallpox vaccine has heightened public awareness of safety issues because this vaccine causes more serious adverse events than other routinely administered vaccinations. 7, 8 The public must know that vaccine safety concerns are taken seriously and investigated by independent professionals whose primary responsibility is safety, not financial gain, public image, or program goals.
