Challenges and Controversies in Immunization Safety

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Immunizations ranked among the greatest public health accomplishments during the 20th century in the United States.11, 12 Advances in biotechnology offer substantial promises in additional disease control through new vaccines, 36 especially when combined with new funding mechanisms for the developing world.66 Increasing public concern about vaccine risks and vaccine safety, both real and perceived, however, has cast a shadow over these achievements and possibilities (Fig. 1). Vaccines are being linked to diseases ranging from autism to multiple sclerosis.45, 96 In an era of virtual eradication of vaccine-preventable diseases (VPDs) (Table 1), such safety concerns make it increasingly difficult to convince the populace to accept immunizations, raising the spectre of resurgence of VPDs.41 Aside from smallpox and polio, however, few other VPDs are likely to be eradicated globally in the near future. The continued control of VPDs generally will require continued immunizations at as high a coverage as possible. To make this possible, a greater investment is needed in the scientific study of these purported vaccine risks to identify which are truly attributable to vaccines.26 Should such an attribution be established, then further research is needed to identify the magnitude of the risk, the risk factors, the pathophysiology, and, hopefully, a safer vaccine.27 This article reviews methods used to understand vaccine safety better and summarize recent developments and controversies (Table 2).

Section snippets

Prelicensure

Vaccines are tested for safety and efficacy in the laboratory, in animals, and in phased human clinical trials before licensure. Due to their experimental design (i.e., randomization, placebo-control, blinding), inferences on the causal relationship of an adverse event with the vaccine in such trials are relatively straightforward. Unfortunately, although helpful in providing data on common acute vaccine reactions (e.g., fever, swelling), prelicensure trials usually cannot provide data on rare

Rotavirus Vaccine and Intussusception

Tetravalent rhesus-based rotavirus vaccine (RRV-TV) was licensed by the Food and Drug Administration (FDA) on August 31, 1998 and recommended for routine childhood immunization.1, 17 In prelicensure studies, intussusception occurred in 5 of 10,054 vaccine recipients and in 1 of 4633 controls but the difference was calculated not to be statistically significant.79 The Advisory Committee on Immunization Practices (ACIP) recommended postlicensure surveillance for intussusception.17 During

VACCINE RISK COMMUNICATIONS

Vaccine safety controversies have posed challenges in communicating with the public and partners about vaccine risks.3 Understanding how the public perceives vaccine risks can have public health consequences. During the 1970s and 1980s, several countries lost confidence in the whole cell pertussis vaccines with subsequent resurgence of pertussis disease.41 Persons claiming religious and philosophical exemptions to measles vaccination had a 35-fold increased risk of measles during the 1989–1991

FUTURE CHALLENGES

Just as health and life expectancy has improved as never before in the United States (and many other countries), 11 paradoxically, one of the major tools to attain this public health success—immunizations—has come under close scrutiny as never before. This paradox is more understandable if one examines the surveillance data for number of vaccine-preventable diseases and vaccine adverse events reported (see Table 1). To the modern parent, and increasingly to health providers, the relative

ACKNOWLEDGMENT

The authors thank Anne Huang, MPH, for her assistance in preparing the manuscript and Georges Peter, MD, for his helpful comments.

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    Address reprint requests to Robert T. Chen, MD Vaccine Safety and Development Activity (MS-E61) National Immunization Program Centers for Disease Control Atlanta, GA 30333 [email protected]

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    Vaccine Safety and Development Activity, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia

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