Challenges and Controversies in Immunization Safety
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