Background and Scope of the Problem

Recent surveys have demonstrated that 85% of U.S. pediatricians encountered immunization refusal during the preceding 12 months,¹ only 77% of 3-year-olds had received all recommended vaccines,² and 25% of parents believe a theory that the total number of vaccines and number administered simultaneously harm the immune system.³ This is difficult for physicians because prevention is an important aspect of pediatric care, and immunization is a cornerstone of prevention. If parents disagree with the physician about immunization, trust, which is so important in a productive physician-patient relationship, is undermined. Some physicians may fear legal repercussions from failing to immunize, or worry about resurgence of disease. Frustration, disappointment, and even anger may result when physicians are unable to provide this critical aspect of well child care.

Approach to Vaccination Refusal

Some physicians dismiss families who decline vaccination. Because children need access to health care for reasons other than immunization, the American Academy of Pediatrics (AAP) discourages dismissal unless a substantial level of distrust or philosophical differences has developed.⁴

The first step in dealing with vaccine refusal is to explore with the family their basis of concern or reservation about vaccines. Their vaccine fears may be based on relatively weak conceptual grounds, which may be overcome with education. Some families have more deep-seated belief systems, often rooted in dubious information and recommendations. The clinician must understand the belief system in order to confront it. To simply dismiss the family’s concerns will cause some to seek another health-care provider who will acquiesce to their requests or demands. The physician should be honest about what is known (and not known) about risks and benefits of immunization.⁴ The family should be counseled about disease prevalence, both in the United States and globally, because of increased international travel. Counseling should include estimates of potential morbidity and mortality should the child become infected.

Most modern-day parents have never seen the diseases that currently available vaccines prevent. The U.S. vaccination program may be a victim of its own success. Some parents now wonder why their children must receive shots to prevent diseases that they perceive do not even exist. Parents may be aware of vaccine preservatives, adjuvants, other additives, or residual substances from the production process. Gelatin and egg proteins may be present in quantities sufficient to cause severe hypersensitivity reactions, but these are quite rare. Minute amounts of other substances, including thimerosal, formaldehyde, aluminum, antibiotics, and yeast proteins have never been shown to be harmful in either experimental animals or humans.⁵

Parents are often influenced by misinformation. Sources of misleading information include well-meaning friends and family members, books devoted to the hazards of vaccines, and even some antivaccination health-care practitioners. The Internet is a major vehicle for dissemination of antivaccination material that may sound official. Many sources refer to dubious scientific studies, whereas others emphasize heart-wrenching personal testimonies about children who were allegedly harmed by vaccines, and others decry health-care conspiracies.

To address parental concerns, physicians should understand the considerable effort and multiple steps are required to develop safe, effective vaccines and put them into routine use. This complex process initially involves animal and human safety testing followed by large-scale testing for efficacy, immunogenicity, and safety in the target population, followed by Food and Drug Administration (FDA) approval and licensure. The Advisory Committee on Immunization Practices (ACIP) advises the Centers for Disease Control and Prevention (CDC), and the candidate vaccine is recommended for addition to the immunization schedule. Next, independent professional organizations (e.g., the AAP) release their recommendations with modifications as appropriate. Finally, public and private insurance companies approve vaccine coverage and put it into action in the community.

Vaccine safety is of paramount importance for the ACIP, professional organizations, practitioners, and parents. However, “safe” does not imply “risk free.” All vaccines have potential adverse reactions that are usually discovered before licensure. Minor side effects such as injection site pain may be fairly frequent with some vaccines. Major adverse events must be very uncommon for a vaccine to ever achieve licensure. Sometimes rare but important side effects are captured only by postmarketing surveillance. Physicians should know and remind parents that reports of adverse events associated with vaccinations are continuously reviewed by the FDA.

For parents (and sometimes children), immunizations are a memorable event such that, if a child develops a condition in temporal relationship to receipt of a vaccine(s), they may assume a causal relationship, when the timing may be a chance coincidence. There are several well-publicized “associations” that lack credible evidence.