Risk Communication and Vaccination: Workshop Summary (1997)

goals of risk communication are probably not well-served by either of these extreme positions. A statistician and public health policy analyst suggested that overconfidence about risk estimates that are later shown to be incorrect contributes to a breakdown of trust between public health officials, vaccine manufacturers, and the public.

A political scientist noted that many scientific studies on vaccine adverse events yield only a recommendation for further study. "The inquiry of science is never ultimately finished," he said. Public policy, therefore, is always made in the absence of final information. "Politics is about decisionmaking in the absence of complete information," he said.

In the United States, the main sources of information about vaccine risks or benefits are vaccine information statements issued by CDC, manufacturers' package inserts that accompany vaccines, oral communications from health care providers, and publicity provided by a variety of nonprofit organizations.⁵

Vaccine information Statements (VISs) are produced by the technical, educational, and legal staff of CDC, with input from specialists in education and low-literacy reading, physicians, and parents. Public and private providers are required by law (P.L. 99–660) to give VISs each time that a vaccine is administered. These statements, written at a fifth- to seventh-grade reading level, attempt to describe concisely the benefits and risks of vaccines. They also include a description of the National Vaccine Injury Compensation Program, information about the federal Vaccine Adverse Event Reporting System (VAERS), and other relevant information. Each VIS is one sheet of paper. VISs are available in 13 languages. (See Appendix B for an example of a VIS.)

VISs were not intended to substitute for provider knowledge or for parent-provider communication, but rather to make such communication easier, according to a physician who coordinated the development of the VISs. Studies show that some knowledge is gained from reading VISs in an ideal setting, in which the research interviewer minds the child and the parent reads at his or her leisure. "However, even under these optimal circumstances, immediate and long-term recall is far from impressive," she said. One study showed that only 54 percent of parents coming to a clinic with an infant or toddler knew that there were two types of polio vaccine, a statement that appears in a large, bold heading on the front of the polio VIS (Humiston et al., 1996).

The target audience for VISs is a diverse group with a wide range of interests and abilities. The statements have been criticized by some as having too high a reading level. The statement about the polio vaccine, for example, requires a reading level beyond the capability of 57 percent of an inner-city Philadelphia clinic population (Melman, et al., 1995). In contrast, some criticize the VISs for not providing enough information. For parents who wish to know more than is provided in a VIS, a notation on each states, "If you want to learn more, ask your doctor or nurse. She/he can give you the vaccine package insert or suggest other sources of information."

The primary tool for communicating the risks and benefits of a vaccine to health care providers is the manufacturer's vaccine package insert. This insert includes statements on efficacy, contraindications, warnings, precautions, and adverse events associated with use of the vaccine. The information in the package insert comes from clinical trials conducted with the vaccine, postmarketing studies, spontaneous adverse events reported to the manufacturer, and adverse events reported to VAERS and in relevant medical journals. Package inserts are regulated by the FDA, which determines the type of information that must be included and reviews and approves each package insert prior to marketing and whenever changes are made. Factual statements in a package insert must be supported by data from clinical studies and references to scientific literature.

The contraindications section of the insert discusses situations or conditions, such as known or suspected severe egg allergy, for which a vaccine should not be used because the risks apparently outweigh the benefits. The warnings section describes serious adverse events and potential safety hazards, as well as limitations in the use of the product and steps that should be taken if these limitations occur.

For example, giving an intramuscular injection to a child with a coagulation disorder would generally be excluded, but, in the face of an epidemic, it might be considered. The precautions section includes special care to be given for the safe and effective use of the product. For example, epinephrine should be available to counter any unexpected anaphylactic reactions that occur at the time of injection.

The adverse events section lists undesirable effects associated with the use of the products that may occur as part of the action of the product. The section includes estimates of the risk of common local and systemic reactions, as well as (wherever possible) estimates of the risk of rare or unusual reactions such as vaccine-associated polio after vaccination with the oral polio vaccine or Guillain-Barré syndrome after vaccination with the tetanus vaccine. According to a pharmaceutical company representative, litigation concerns dictate that this section also must list events that are not generally thought by scientists to be caused by the vaccine. Sudden infant death syndrome (SIDS) after vaccination with the diphtheria and tetanus toxoids and pertussis vaccine (DTP), for instance, for which several studies and an Institute of Medicine (IOM) report have found that there is evidence of no causal association (Institute of Medicine, 1991), is still mentioned. This legal necessity undercuts the ability of these statements to communicate clearly the risks of vaccines.

Advertising and other promotional materials generated by a vaccine manufacturer about its products are also heavily regulated by FDA, which requires that the materials provide a fair balance of safety and effectiveness information, make specific claims, and be supported by properly referenced data. Manufacturers must submit advertising for FDA review and approval prior to use for products that are not yet licensed, products for which licensure is pending, and products within the first 120 days after licensure.

Vaccine manufacturers also publish informational brochures for parents; these brochures usually do not specify a product brand name. According to a vaccine manufacturer's representative, these brochures provide information about the disease, state that a vaccine exists to protect against the disease, that there may be side effects from the vaccine, that not all people should receive the vaccine, and that vaccine usage should be discussed with a physician. The brochures are intended by the manufacturers to facilitate communication about vaccines between

patient or parents and provider. Some other participants suggested that the brochures are a form of advocacy for vaccine use, in addition to providing such information.

A number of nonprofit organizations communicate vaccine benefits and risks to the public. Organizations that promote immunization include the Children's Defense Fund, the Children's Action Network, Kiwanis International, and the American Academy of Pediatrics. A consumer advocate indicated that most of these organization are funded by corporations or by the U.S. government and most do not discuss the risks associated with immunizations in their promotional materials. Organizations whose goal is to inform consumers about vaccine risks include the National Vaccine Information Center, Parents for Freedom of Choice, and Vaccine Information and Awareness. Many of these organizations are funded by individual donations and put their emphasis on the risk side of the equation.

Communication between health care providers and parents or patients is often limited, noted a practicing pediatrician, because the time that doctors have to spend with patients during an office visit is restricted. When communicating vaccine risks and benefits, consequently, practitioners often rely on materials such as the VISs, educational videos, or information provided by ancillary personnel. The speaker said he often gives parents the VISs at the first well-child visit, before the child is scheduled to receive any immunizations. This allows parents time to review the information in the statements and generate any questions before their next visit, during which the immunizations are administered. Although he does discuss some potential adverse events, the speaker acknowledged that he tends to emphasize the decreased risk of disease provided by the vaccine, often giving examples of the morbidity and mortality associated with the diseases against which the vaccines are protective.