Policy Science

Primer: Vaccine Policy

The administration, distribution, and safety of vaccines are regulated through multiple federal agencies as well as through state-level statutes. Two main bodies oversee administration and safety of vaccines: the Vaccines and Related Biological Products Advisory Committee in the FDA (FDA VRBPAC) and the Advisory Committee on Immunization Practices in the CDC (ACIP). The FDA VRBPAC performs the primary safety evaluation of novel vaccines. To be released to the public, new products must get approval of this committee. Next, the ACIP is tasked with developing recommendations for the age restrictions, contraindications (specific medical scenarios when a drug/treatment should not be administered), and scheduling (dosage and timing) of vaccines. The director of the CDC and the U.S. Department of Health and Human Services must approve these recommendations. Once it has been approved, the guidelines of the recommendation are published in the CDC’s Morbidity and Mortality Weekly Report, at which point the recommendations are the official statement of the federal government.

Although the CDC, a federal agency, establishes the country’s official recommendation on the administration of vaccines, these recommendations are not requirements. Ultimately, state laws establish vaccination requirements for citizens and may supersede federal recommendations. There are two main types of statutes through which states are able to control the usage of vaccines.

First, all states have some form of legislation that establishes vaccination requirements for school children and healthcare workers. From state to state, these laws are quite variable. State laws on school and childcare vaccination establishes vaccination requirements for not only public schools, but also private schools, colleges and universities, and, in some states, day care services. In many states, the law is written so that vaccination policies in private schools and day cares must reflect the public school guidelines. However, all states have policies allowing for exemptions from these requirements. There are 3 main types of exemptions: medical (50/50 states), religious (47/50 states), and philosophical (18/50 states). The 2014-2015 measles outbreak in California spurred a change in policy, passing California Senate Bill-277 that removed religious exemptions and made California one of three states with ONLY medical exemptions. The situation in California has provided an interesting case study on public reaction to mandatory vaccinations. Multiple challenges to this policy have been mounted through litigation, including, in 2016, Buck vs. State of California, which argued that the policy violated a “right to education for children” but has since been dismissed. In addition to mandatory vaccination for schools, state laws also establish guidelines for healthcare workers. There are 4 types of statutes that apply to healthcare workers: assessment requirements, offer requirements, ensure requirements, and laws that require workers without an influenza vaccine to wear surgical masks while at work. Again, these policies vary greatly from state to state and even from facility to facility.

Secondly, state laws also control restrictions on the accessibility of vaccines. Today, in all states, pharmacists are allowed to administer vaccines, but there is variability in the restrictions controlling administration. Many states allow pharmacists to administer vaccines with the most recent ACIP recommendations, but some states impose additional restrictions. Three important types of provisions that a state may enforce include: age restrictions, state vaccine restrictions, and third-party authorization requirements. In the case of age and state vaccine restrictions, states may decide to ignore ACIP recommendations and determine their own guidelines for vaccine administration. Third-party authorization requirements are laws that allow a state to first review new CDC recommendations for approval before pharmacists are allowed to administer a new vaccine. State legislatures have used both of these levers, requirements and restrictions, to control the distribution of vaccines.

Vaccine safety has long been a topic of public discussion in the United States. The first major policy response to safety concerns was the National Childhood Vaccine Injury Act (NCVIA) of 1986. The law was enacted in response to public question of whether the DPT vaccine, which protects against diphtheria, pertussis (whooping cough), and tetanus, was associated with childhood brain injury. To date, no studies have shown a causal relationship between the DPT vaccine and brain injury. However, the NCVIA has had a significant impact on the landscape of vaccination in the United States by establishing several federal programs that are still in place. Primarily, the law established the National Vaccine Injury Compensation Program (VICP), created to compensate claims of persons filing vaccine injury claims. According to the National Vaccine Information Center, the NVICP has awarded $2 billion in compensation, but two of three applicants have been denied. Additionally, the NCVIA has created several new advisory committees in the Department of Health and Human Services and introduced new laws requiring doctors to distribute Vaccine Information Statements to any patients receiving a vaccine.

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