KEY POINTS
■ Health care providers who care for children should have a thorough grasp of the complex issues—such as safety, adherence, cost, and scheduling—that may hinder successful implementation of immunization programs.
■ The CDC recommends vaccination against 13 diseases—hepatitis B infection, rotavirus infection, diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib) infection, pneumococcal disease, polio, measles, mumps, rubella, chickenpox, and hepatitis A infection—by age 18 months.
■ Additional recommended vaccines are the adolescent/adult formulation of the diphtheria, tetanus, and pertussis vaccine, the meningococcal vaccine, and the human papillomavirus vaccine (for females) at ages 11 to 12 years. All children should receive the seasonal flu vaccine annually from age 6 months until their 19th birthday.
■ Recent evidence overwhelmingly rejects a causal relation between the measles-mumps-rubella vaccine and autism.
Immunization is a cornerstone of health care policy and a key component in infectious disease prevention. The savings in lives and money are almost incalculable. Vaccines have reduced mortality from diseases such as smallpox, polio, diphtheria, and measles by 99.9%.1 The seven recommended routine childhood vaccines save an estimated $10 billion in direct costs and $43 billion in societal costs in the United States alone.2
Although the benefits of vaccines are overwhelmingly positive from economic and medical science perspectives, complex issues—such as safety, adherence, cost, and scheduling— hinder the implementation of immunization programs. Health care providers who care for children should have a thorough grasp of these potential complications and be prepared to educate parents appropriately so that barriers to adherence can be minimized. This paper reviews evidence on the safety of the recommended childhood vaccines and discusses methods that can improve adherence to immunization programs.
IMMUNIZATION RECOMMENDATIONS
The CDC recommends that children in the United States be immunized against 13 diseases—hepatitis B infection, rotavirus infection, diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib) infection, pneumococcal disease, polio, measles, mumps, rubella, chickenpox, and hepatitis A infection—by age 18 months.3 Separate vaccinations are not required for all 13 diseases and some are administered in a series; therefore, completion of the recommended regimen requires 25 injections.
At age 11 to 12 years, children should receive the adolescent/ adult formulation of the diphtheria, tetanus, and pertussis (DTP) vaccine and meningococcal vaccine; females should also receive the three-dose series against human papillomavirus (HPV).4 An annual infl uenza vaccination is recommended for all children from age 6 months until their 19th birthday,5 and certain high-risk children may need immunization against additional diseases.
Safety monitoring All vaccines in the United States must undergo extensive computer trials, animal trials, and clinical trials before they are licensed by the FDA. Manufacturers also must submit samples of each vaccine lot to the FDA before the vaccines are released for administration to the general public.
The National Childhood Vaccine Injury Act requires health care providers to report adverse events that occur subsequent to vaccination. The Vaccine Adverse Event Reporting System (VAERS) was established by the CDC and FDA to manage this information. VAERS reports can be made by anyone, but most reports are made by vaccine manufacturers (42%) or health care providers (30%). Reportable events are those deemed by the manufacturer to be a contraindication for subsequent doses or an event listed in the vaccine injury table (eg, the reportable events for the tetanus vaccine are anaphylaxis, brachial neuritis, and any acute complications or sequelae of these events).6 The complete table is available at www.hrsa.gov/vaccinecompensation/table.htm.
VAERS is a passive surveillance system; therefore, its limitations include underreporting, variability in report quality, and uncertainty of causality.7 The Vaccine Safety Datalink (VSD) addresses some of these weaknesses. The VSD project is a collaborative effort between the CDC and eight large managed-care organizations in which comprehensive medical and immunization histories of 5.5 million people are compiled. This large quantity of data allows for both planned vaccine safety studies and timely analysis of developing hypotheses.6