Saturday, July 7, 2012

Immunization laws

Our son - nose, lips, chin, and cheek.
I started this blog to discuss childhood immunizations but I've spent the last six months discussing vaccines and pregnancy, adult vaccines, and some immunization principles. Our son will born soon - very soon - so it's time for me to shift gears.

A number of surveys of adults have found that the majority of parents vaccinate their children according to the recommended immunization schedule and consider their health care providers to be reliable sources of immunization information (Gust et al., 2008; Kennedy et al., 2011). Although most parents of young children in the U.S. do not remember epidemics of vaccine-preventable diseases, most parents recognize that vaccines are an important way to prevent diseases (Freed et al., 2010; Gust et al., 2005). I suspect that, other than when they register their children for school and must present their children's immunization records, most parents don't give much thought to school immunization laws. Nevertheless, given some of the comments I hear from parents as well as news stories about mandated vaccines, I think there is some confusion about vaccine laws in the U.S.

First, school immunization laws are state laws. There are no federal immunization laws.

There are two operating divisions of the U.S. Department of Health and Human Services that are involved with regulating and recommending vaccines. The Food andDrug Administration (FDA) approves and licenses vaccines marketed in the U.S. The Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) publishes immunization recommendations. Occasionally, there are some differences between what the FDA approves and what the ACIP recommends. For example, the FDA approved herpes zoster (shingles) vaccine for persons 50 years of age and older while the ACIP recommends shingles vaccines for persons 60 years of age and older.

Neither the FDA nor the CDC mandate vaccines. In fact, the CDC is not a regulatory agency.

In Jacobson v. Massachusetts (1905), the U.S. Supreme Court affirmed states' authority to mandate vaccines. The court recognized the duty of the state to preserve the safety of the general public. Each state has its own school immunization laws and the requirements for school entry differ from state to state. In general, the states follow the ACIP recommendations; however, some vaccines recommended by the ACIP are not required by every state. One example is human papillomavirus (HPV) vaccine. The ACIP recommends HPV vaccine for males and females ages 9 through 26 years. Currently, the only state to require HPV vaccination for school entry is Virginia (6th grade, girls only).

All states require DTaP/Tdap, MMR, polio, and varicella (chickenpox; documentation of immunity from natural infection may be acceptable) immunizations for school entry. The number of doses required varies between states as do the requirements for other vaccines such as hepatitis B, hepatitis A, meningococcal, and pneumococcal vaccines.

Just as the school immunization laws vary between states, immunization exemption laws also vary between states. There are three types of immunization exemptions: medical, religious, and personal/philosophical. Children for whom an immunization is contraindicated may obtain a medical exemption, which usually requires documentation of the reason for the exemption from a medical provider. All 50 states allow medical exemptions. Forty-eight states allow religious exemptions and 20 states allow personal/philosophical exemptions.

The requirements for obtaining an exemption vary between states. Some states require only a parent's signature on an exemption forum to obtain either a religious and/or personal/philosophical exemption. Other states have additional requirements. Last year, the Washington State legislature changed the requirement for obtaining a person/philosophical requirement. Prior to 2011, a parent or guardian could simply sign an exemption form. ESB 5005 requires the signature of a licensed health care professional who has counseled the parent on the benefits of vaccinating and the risks of not vaccinating.

Not surprisingly, states in which exemptions are easily obtained tend to have higher exemption rates (Rota et al., 2001). Several studies have concluded that nonmedical exemptions increase the incidence of vaccine-preventable diseases and increase the risk of those diseases in babies too young to have been immunized, people with medical contraindications to vaccines, and those who received the vaccine but did not develop adequate immunity (primary vaccine failure) or lost their immunity (secondary vaccine failure) (Feikin et al., 2000; Glanz et al., 2009; May & Silverman, 2003; Omer, Engler, et al., 2008; Omer, Pan, et al., 2006; Omer, Salmon, et al., 2009).

Students with immunization exemptions may be excluded from school during an outbreak of a vaccine-preventable disease (NNII, 2011). In Washington State, a local (county) health officer may require non-immunized students to be excluded from school during an outbreak (WAC 246-110-020).

Parents of infants and school-age children should review the immunization requirements for the state in which you live. See additional information below.

The ACIP recommends a dose of hepatitis B vaccine at birth, so that will be the topic of my next post.

Additional information:

Immunization Action Coalition:
National Network for Immunization Information:

Feikin, D. R., Lezotte, D. C., Hamman, R. F., Salmon, D. A., Chen, R. T., Hoffman, R. E. (2000). Individual and community risks of measles and pertussis associated with personal exemptions to immunizations. JAMA, 284(24), 3145-3150.

Glanz, J. M., McClure, D. L., Magid, D. J., Daley, M. F., France, E. K., Salmon, D. A. et al. (2009). Parental refusal of pertussis vaccination is associated with an increased risk of pertussis infections in children. Pediatrics, 123(6), 1446-1451.

Freed, G. L., Clark, S. J., Butchart, A. T., Singer, D. C., & Davis, M. M. (2010). Parental vaccine safety concerns in 2009. Pediatrics, 125(4), 654-659.

Gust, D., Brown, C., Sheedy, K., Hibbs, B., Weaver, D., & Nowak, G. (2005). Immunization attitudes and beliefs among parents: beyond a dichotomous perspective. American Journal of Health Behavior, 29(1), 81-92.

Gust, D. A., Darling, N., Kennedy, A., & Schwartz, B. (2008). Parents with doubts about vaccines: which vaccines and reasons why. Pediatrics, 122(4), 718-725.

Kennedy, A., Basket, M., & Sheedy, K. (2011). Vaccine attitudes, concerns, and information sources reported by parents of young children: results from the 2009 HealthStyles survey. Pediatrics, 127(Supple. 1). S92-S99. Retrieved June 10, 2011 from

May, T. & Silverman, R. D. (2003). ‘Clustering of exemptions’ as a collective action threat to herd immunity. Vaccine, 21, 1048-1051.

National Network for Immunization Information. (2011). Exemptions from immunization laws. Retrieved July 7, 2012 from

Omer, S. B., Enger, K. S., Moulton, L. H., Halsey, N. A., Stokley, S., & Salmon, D. A. (2008). Geographic clustering of nonmedical exemptions to school immunization requirements and associations with geographic clustering of pertussis. American Journal of Epidemiology, 168(12), 1389-1396.

Omer, S. B., Pan, W. K. Y., Halsey, N. A., Stokley, S., Moulton, L. H., Navar, A. M. et al. (2006). Nonmedical exemptions to school immunization requirements: secular trends and association of state policies with pertussis incidence. JAMA, 296(14), 1757-1763.

Omer, S. B., Salmon, D. A., Orenstein, W. A., deHart, P., Halsey, N. (2009). Vaccine refusal, mandatory immunization, and the risk of vaccine-preventable diseases. New England Journal of Medicine, 360(19), 1981-1988.

Rota, J. S., Salmon, D. A., Rodewald, L. E., Chen, R. T., Hibbs, B. F. et al. (2001). Process for obtaining nonmedical exemptions to state immunization laws. American Journal of Public Health, 91(4), 645-648.

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