tracted media coverage and further stimulated public fears about vaccine safety, even though little is known about the biological origins of autism. Further research has been recommended on this subject, but the scientific groups responsible for vaccine recommendations have also urged the continued use of the MMR vaccine in the absence of research or clinical evidence that would establish a convincing connection between vaccine use and the emergence of this disorder.

Vaccine safety concerns related to other disorders (e.g., childhood diabetes and multiple sclerosis) have also drawn large amounts of media attention. When claims are made about possible links between specific health and behavioral disorders and vaccine use, extensive efforts are required to determine the strength of the evidentiary base that supports each claim. Future additions to the vaccine schedule may contribute to concerns about vaccine safety, increase the likelihood of adverse events, and necessitate more resources for surveillance and for such efforts to investigate claims of health risks at both the national and local levels.

Federal Role. Before vaccines reach the market, private manufacturers implement rigorous measures designed to ensure the safety of their products. Vaccine manufacturers are required to document and report in the clinical trials literature any adverse health effects that are detected prior to the approval and licensing of a new vaccine product. Once a vaccine is in widespread use, health providers that administer vaccines and vaccine manufacturers are expected to report any adverse effects to DHHS.

There are two federal programs related to vaccine safety: the Vaccine Adverse Events Reporting System (VAERS) and the National Vaccine Injury Compensation Program (VICP). Following the passage of the National Childhood Injury Act of 1986 (P.L. 99–66), DHHS established VAERS to accept all reports of suspected adverse events among all age groups after the administration of any U.S. licensed vaccine in the public or private sector. Operated jointly by the Food and Drug Administration and CDC, VAERS was created primarily to serve as a signaling system for adverse events not detected during premarket testing (Food and Drug Administration, 1998).

VAERS currently receives 800–1,000 reports each month. About 85 percent of the reports concern relatively minor adverse events, such as swelling at the injection site and ordinary fevers. The remaining 15 percent involve serious side effects, such as high fever, seizure, life-threatening illness, or death. Upon analysis of VAERS reports, the Food and Drug Administration has the authority to recall a vaccine if it represents a risk to the American public. Only three batches of vaccine have been recalled during the last 10 years (Food and Drug Administration, 1999).

The National Childhood Injury Act of 1986 also established VICP,

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement