Leila Barraza

Measles Outbreak as a Catalyst for Stricter Vaccine Exemption Legislation

Following a multistate measles outbreak that began in Disneyland, California legislators responded to the outbreak by passing legislation repealing exemptions for philosophical and religious beliefs.1 Although the legislation retains medical exemptions, it makes California the largest state to have such strict childhood vaccination requirements, joining only West Virginia and Mississippi. Beginning in the 2016-2017 school year, children whose parents refuse vaccination and are unable to secure a medical exemption must be homeschooled.1 School-aged children who currently claim a nonmedical exemption can maintain it until the time they enter kindergarten or seventh grade, the state’s 2 vaccine checkpoints.1 The law applies to both public and private schools, as well as day care facilities.1

Human Papillomavirus and Mandatory Immunization Laws What Can We Learn From Early Mandates

Human papillomavirus (HPV) is a sexually transmitted virus that infects an estimated 14 million Americans annually. More than 150 subtypes of HPV have been identified. Some types are carcinogenic and cause an estimated 27,000 cancers among men and women in the United States annually; non-carcinogenic subtypes can cause anogenital warts. The first HPV vaccine, a quadrivalent (HPV4) vaccine, licensed in 2006, offers protection against 4 subtypes of HPV (6, 11, 16, and 18) that cause 70% of cervical cancers and 90% of genital warts. The vaccine is administered as a series of 3 injections at 0, 2, and 6 months. A second HPV vaccine, which offers protection against subtypes 16 and 18 and protects against cervical cancer but not genital warts, was licensed in 2009. The quadrivalent vaccine, HPV4, is now being replaced with HPV9, a vaccine that protects against 9 subtypes of HPV (6, 11, 16, 18, and 5 others) that cause 85% of cervical cancers. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended in 2007 that all females receive an HPV vaccine at 11-12 years of age so that protection is gained before exposure to the virus is likely to occur. The current recommendations include all adolescents and the vaccine is also recommended for unvaccinated women through 26 years of age, heterosexual males through 21 years of age, and men who have sex with men through 26 years of age. HPV vaccines are highly effective in preventing infection if administered before exposure. A 2016 study found that HPV infection rates decreased from 11.5% in 2003-2006 to 4.3% in 2009-2012 among 14to 19-year-old girls after the vaccine became available. Evidence supports the vaccine’s safety; the only serious adverse reactions associated with the vaccine are syncope and skin infections. Despite strong evidence of the vaccine’s effectiveness and safety, however, public acceptance and uptake of the vaccine are slow. Although the proportion of adolescents receiving other recommended vaccines is increasing, the proportion of adolescents receiving the HPV vaccine appears to be plateauing. In 2014, 60% of adolescents aged 13-17 years received at least 1 dose of HPV vaccine and 40% received all 3 doses, whereas 86% received the DTaP (diphtheria, tetanus, acellular pertussis) vaccine. HPV vaccination has been controversial in the United States because the vaccine touches on 2 contentious topics: teenage sexuality and mandatory vaccination. Because of the public’s perceptions about HPV’s status as a sexually transmitted virus and dissent about the recommended age of vaccination, states have had difficulty making the vaccine mandatory for school admission. Some opponents of a school entry mandate for this vaccine have argued that it infringes upon parental rights to discuss the topic of sex on their own terms. Others have raised concerns that HPV vaccination may increase teenage promiscuity, although evidence disproves this claim.

Global Emergency Legal Responses to the 2014 Ebola Outbreak: Public Health and the Law

From their relative obscurity over the past three decades, varied strains of Ebola disease have emerged as a substantial global biothreat. The current outbreak of Ebola, beginning in March 2014 in Guinea, is projected to infect tens of thousands of people before being brought under control. Some estimate the outbreak could exceed 100,000 cases and extend another 12-18 months. Ebola’s spread has the potential to extend across the globe, but is concentrated in several African countries (e.g., Democratic Republic of Congo, Sierra Leone, Liberia, Guinea, Nigeria, and Senegal). Collectively, these countries are home to nearly 290 million people. Among Liberia’s population of 4.1 million, over 1,100 people have already died from Ebola in less than 6 months; by comparison, if this same outbreak and death rate occurred in the United States, over 88,000 Americans would perish. With the numbers of infected still expanding and reported mortality rates exceeding 40% of those infected, international, national, and regional governments have launched various states of emergency authorizing a plethora of public health powers.

The Latest in Vaccine Policies: Selected Issues in School Vaccinations, Healthcare Worker Vaccinations, and Pharmacist Vaccination Authority Laws:

This paper discusses recent changes to state legal frameworks for mandatory vaccination in the context of school and healthcare worker vaccination. It then discusses state laws that allow pharmacists the authority to vaccinate.

Regulations and policies regarding e-cigarettes

Electronic cigarettes (e‐cigarettes) are a growing public health concern because of a dramatic increase in use by adolescents and the uncertainty of potential health impacts. These health concerns and lack of an established federal regulatory scheme have led many local and state governments to address the regulatory void for e‐cigarettes by incorporating them into the statutory definition of tobacco or by passing laws specific to the use of e‐cigarettes. In August 2016, the US Food and Drug Administration issued a final rule deeming e‐cigarettes within their authority; providing uniform requirements like premarket approval applications, Harmful and Potentially Harmful Constituents reporting, and warning labels; and establishing 18 years as a minimum age of purchase. Although the impact on the publics health remains uncertain, regulations and laws governing e‐cigarettes continue to develop. This review highlights the available data regarding safety and public health impacts of e‐cigarettes and details the status of US regulations and policies affecting their sale and use. Cancer 2017;123:3007–14.

Major Trends in Public Health Law and Practice: A Network National Report

Since its inception in September 2010, the Network for Public Health Law has responded to hundreds of public health legal technical assistance claims from around the country. Based on a review of these data, a series of major trends in public health practice and the law are analyzed, including issues concerning: the Affordable Care Act, tobacco control, emergency legal preparedness, health information privacy, food policy, vaccination, drug overdose prevention, sports injury law, public health accreditation, and maternal breastfeeding. These and other emerging themes in public health law demonstrate the essential role of law and practice in advancing the publics health.

The Legal Implications of HIPAA Privacy and Public Health Reporting for Correctional Facilities

Inmates in cramped living quarters, a situation common to correctional facilities, are especially vulnerable to disease. Cramped living conditions, coupled with above-average rates of HIV, tuberculosis, and other communicable diseases, increase inmates’ risk of problematic health outcomes. Thus, high-quality health care and sustained efforts to prevent disease are especially important to improve inmate health within correctional facilities. Compliance with federal privacy restrictions pursuant to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and state disease reporting requirements will foster inmate health and assist efforts to prevent the spread of disease. This article examines the interplay between HIPAA rules and state reporting laws to preserve health information privacy and to control the spread of disease.

A Proposed Ban on the Sale To and Possession of Caloric Sweetened Beverages by Minors in Public

Obesity is the definitive epidemic of the modern era in the United States. Its well-documented public health impacts, especially related to children and adolescents, are horrific. Nearly one-third of American minors are overweight; over 50% of them are obese. Already, these kids suffer from multiple adverse physical and mental health conditions. Sadly, absent serious communal and individual interventions, their lives may be cut short compared to their own parents’ life expectancy. While recent surveillance suggests childhood obesity may be trending down slightly in some populations, public health experts remain concerned about the threat obesity poses to the health of America’s youth.

More Research Needed to Increase Policies for HPV Vaccine Uptake

The authors discuss the need for more research to support vaccination against human papillomavirus (HPV) infections. They mention the states that have developed policies regarding the vaccinations, the need for more research into disparities in vaccination, and the arguments against vaccination.

Practice-Based Research Networks and the Mandate for Real-World Evidence

The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.