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

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.

Parent Information Brochures

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



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