The success of the childhood immunization initiative in the United States is clearly demonstrated by the low incidence of vaccine-preventable diseases. With the widespread use of vaccines in the United States and the near-eradication of many childhood diseases that were common just a generation ago, parental concern has shifted from the harm and suffering caused by vaccine-preventable diseases to possible adverse events associated with vaccination.
Policies have changed over the past two years to enhance vaccine safety, as seen on the Recommended Childhood Immunization Schedule.1 These changes include removal of thimerosal from infant doses of hepatitis B and Hib vaccines, use of the all-inactivated poliovirus vaccine series for poliomyelitis prevention, removal of rotavirus vaccine due to the risk of intussusception, and use of acellular diphtheria and tetanus toxoids and acellular pertussis vaccine instead of whole-cell diphtheria and tetanus toxoids and pertussis vaccine. Family physicians can take several measures to help with vaccine safety and preserve the public's confidence in vaccines.
First, provide patients or their legal guardian with the most current Vaccine Information Statement (VIS) before vaccination. Under the Public Health Service Act, health care providers who administer any vaccine containing diphtheria, tetanus, pertussis, measles, mumps, rubella, poliovirus, varicella, hepatitis B or Haemophilus influenzae type b antigens are required to provide a copy of the relevant VIS to the patient before vaccination. Every available VIS may be viewed and downloaded in multiple languages from the following Web sites:http://www.cdc.gov orhttp://www.immunize.org/vis/index.htm. For vaccines that have no VIS available, physicians should provide information about the risk of the disease, the protection afforded from vaccination, the risk of vaccine adverse events and what to do if a serious adverse event occurs.
Second, report any adverse reactions temporally related to vaccination. Health care providers are required by federal law to report certain adverse events and should report any adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS). VAERS forms and instructions may be obtained by calling 800-822-7967. This system received reports of cases of intussusception following rotavirus vaccination; this led to an investigation by the Centers for Disease Control and Prevention, which revealed the reaction and ultimately led to its withdrawal from the market.
Third, document the manufacturer, lot number, administration date and person administering the vaccine (including name, title and address) whenever a vaccine is administered. The ability to track vaccine failures or adverse events by lot number will enable authorities to determine whether incidents are lot-dependent or not.
As physicians, we can take comfort in the Vaccine Injury Compensation Program (VICP), which provides for no-fault compensation that can be awarded for specified injuries that are temporally related to administration of vaccinations against measles, mumps, rubella, diphtheria, tetanus, pertussis, poliovirus, hepatitis B, varicella or H. influenzae type b. For vaccines covered by the VICP, the program has reduced the risk of litigation for providers and vaccine manufacturers following adverse events. Information about specific adverse events that are covered is available from the Health Resources and Services Administration by telephoning 301-443-6593.