Jason L. Schwartz

HPV vaccination's second act: promotion, competition, and compulsion.

Developments regarding human papillomavirus (HPV) vaccines will transform HPV vaccination in the United States while simultaneously raising several new policy and ethical concerns. Policymakers, vaccine manufacturers, and the public health community must now respond to the presence of competing vaccines that are similar but distinct, particularly with respect to genital wart prevention and the benefits of vaccinating males. This work arises in the shadow of the contentious introduction of the HPV vaccine Gardasil (Merck & Co, Inc, Whitehouse Station, NJ) in 2006, particularly the opposition to efforts in many states to require the vaccine for school attendance. I review the current status of HPV vaccine policy in the United States and examine issues of public health ethics and policy central to ongoing and future HPV vaccination programs.

The first rotavirus vaccine and the politics of acceptable risk.

Context Vaccination in the United States is a frequent source of controversy, with critics alleging failures by public health officials to adequately identify, monitor, and respond to risks associated with vaccines. In response to these charges, the case of RotaShield, a vaccine withdrawn in 1999 following confirmation of a serious adverse event associated with its use, is regularly invoked as evidence of the effectiveness of current vaccine safety activities. Methods This article examines the history of RotaShield, with particular attention paid to decision making regarding its use in the United States and internationally. I reviewed and analyzed federal advisory committee meeting transcripts, international conference reports, government and scientific publications, media coverage, and other primary and secondary source materials. I also conducted six semistructured interviews with former senior officials and advisory committee members at the U.S. Centers for Disease Control and Prevention who participated in decisions regarding the vaccine. Findings Decision making regarding RotaShield, including the ultimate withdrawal of its recommendation for use, was shaped significantly by government health officials’ concern for preserving public confidence in overall U.S. vaccination efforts amid several unrelated vaccine risk controversies ongoing at that time. This attention to public perception and external pressures occurred in tandem with the evaluation of the quantitative evidence regarding the magnitude and severity of the risk associated with the vaccine. The decisions made in the United States resulted in foreseen but unintended consequences for international use of the vaccine, including in nations where the profile of risks and potential benefits was dramatically different. Conclusions As enthusiasm for evidence-based decision making grows throughout medicine and public health, greater explicit attention should be directed to the processes by which decision makers and their expert advisers evaluate such evidence and translate it into regulation and policy by means of qualitative judgments.

State Vaccination Requirements for HPV and Other Vaccines for Adolescents, 1990-2015

State Vaccination Requirements for HPV and Other Vaccines for Adolescents, 1990-2015 Eight years after human papillomavirus (HPV) vaccines were first recommended in the United States, vaccination coverage is substantially below the Healthy People 2020 target of 80%.1 Data from the US Centers for Disease Control and Prevention (CDC) show that 37.6% of adolescent girls and 13.9% of adolescent boys had completed the 3-dose series in 2013.2 Recent efforts to address these deficits emphasize that HPV vaccines should not be viewed or treated differently than other routinely recommended vaccines.1,2 School requirements are a mainstay of US vaccination policy, widely used by states to promote high vaccination rates. Depending on the vaccine, requirements may exist for attendance at day care, preschool, kindergarten, or higher grade levels.3 Attention to their potential value has been largely absent from recent discussions of strategies to improve HPV vaccination rates. However, requirements were extensively discussed following the approval of the first HPV vaccine in 2006.4 Proponents of vaccination argued at that time that requirements would be premature, explaining that a multi-year implementation period focused on supply, safety, financing, and education is warranted before requiring any new vaccine.5,6 We sought to examine the presence and timing of state requirements for vaccines with particular relevance to adolescent health and to compare those findings to the implementation of HPV vaccines. Methods | Vaccines studied were those used by the CDC to evaluate adolescent vaccination (ie, included in the National Immunization Survey—Teen) that were added to the recommended schedule since 1990 and protected against new disease targets: hepatitis B, varicella, meningococcal conjugate, and HPV. Using legal databases, CDC and other publications, and information from health departments, we identified the earliest date that a requirement, if applicable, took effect for each vaccine in every state and the District of Columbia (DC) for any childhood, adolescent, or college-aged population. Requirements approved through March 2015 were identified, including those with later effective dates. We calculated the time that elapsed between the publication of the corresponding recommendation of the CDC Advisory Committee on Immunization Practices (ACIP) in the Morbidity and Mortality Weekly Report, formalizing a change to the recommended vaccination schedule, and the effective date of each requirement.

Immune to addiction: the ethical dimensions of vaccines against substance abuse

Promising advances have been made in recent years for a unique class of immunotherapies that use vaccination to combat substance-use disorders. Although such vaccines are potentially useful for addictions, they raise a variety of ethical and social questions.

Ethics of vaccination programs.

Ethical issues are present at each stage in the vaccine product life cycle, the period extending from the earliest stages of research through the eventual design and implementation of global vaccination programs. Recent developments highlight fundamental principles of vaccine ethics and raise unique issues for ongoing vaccination activities worldwide. These include the 2009-10 H1N1 pandemic influenza vaccination campaign, renewed attention to the potential global eradication of polio, and the ongoing evaluation of vaccine risk controversies, most notably the alleged link between childhood vaccines and autism. These cases present ethical challenges for public health policy-makers, scientists, physicians, and other stakeholders in their efforts to improve the health of individuals, communities, and nations through vaccination.

When Not All That Counts Can Be Counted: Economic Evaluations And The Value Of Vaccination

With vaccination efforts forced to compete for scarce resources at a time when national health budgets, global health resources, and the global donor community are facing considerable strains, advocates of vaccines have sought to better identify, measure, and articulate the value of vaccination. Critics of current analyses of the value of vaccination argue that a broader view is required, one that includes the additional economic benefits of vaccines or acknowledges the social and ethical aims advanced by vaccination programs. Much of this work has paid inadequate attention to the need to apply any expanded view of value consistently across medical interventions, to the close and complex integration of vaccination efforts with other health initiatives, and to the fact that subjectivity and judgments are present in quantitative and qualitative evidence alike. To fully realize the value of vaccination, far more attention, investment, and research are required to better understand the deliberations and decision-making processes by which any kind of evidence is translated into policy.

“Model” patients and the consequences of provider responses to vaccine hesitancy

The manner in which providers respond to parental concerns about the recommended childhood vaccination schedule is an area of increasing interest in pediatrics and medical ethics. Like many aspects of vaccination policy and practice, evaluating the reactions of providers to parental vaccine hesitancy—including the potential dismissal of such families from their practices—requires an appreciation of the twin character of vaccination as both a public health program as well as an individual preventive intervention. Accordingly, the ethics of vaccination combine many aspects of traditional medical ethics, such as respect for patient autonomy, the primacy of informed consent, and concern for the doctor-patient relationship, with the relatively newer discourse of public health ethics, one that directs particular attention to the health of populations and the pursuit of social justice. When parents are hesitant about vaccination for their children, providers may face a significant challenge reconciling their commitment to the health of those children, their respect for the perspectives of parents, and their interest in the health of their other patients and their communities. The tensions and potential conflicts among these considerations help to explain why provider responses to vaccine hesitancy have emerged as a frequent topic of discussion among practitioners, public health advocates, and ethicists alike.

Achieving an optimal childhood vaccine policy

Policies to remove parents’ ability to opt-out from school immunization requirements on the basis of religious or personal beliefs (ie, nonmedical exemptions) may be a useful strategy to increase immunization rates and prevent outbreaks of vaccine-preventable disease. However, there is uncertainty about the effectiveness of this strategy and the range of possible outcomes. We advocate for a more deliberative process through which a broad range of outcomes is scrutinized and the balance of values underlying the policy decision to eliminate nonmedical exemptions is clearly articulated. We identify 3 outcomes that require particular consideration before policies to eliminate nonmedical exemptions are implemented widely and outline a process for making the values underlying such policies more explicit.

A Half-Century of Prevention — The Advisory Committee on Immunization Practices

In 1964, after a vaccination program against polio, diphtheria, tetanus, and pertussis began, the Advisory Committee on Immunization Practices was created to advise the U.S. government on vaccination activities. The ACIP remains influential domestically and globally.

Rotavirus vaccines, intussusception, and risk-benefit assessments.

Vaccination programs against rotavirus have the potential to dramatically improve the health of children worldwide. Two licensed rotavirus vaccines currently in use have been shown to be highly effective in reducing the burden and consequences of rotavirus-related disease.1 Recently, a third vaccine in late-stage development in India has shown positive results in a large clinical trial. Its approval would provide another option for global rotavirus vaccination efforts, one likely to be more affordable to developing nations where the vast majority of the approximately 500 000 annual deaths attributable to rotavirus occur. In late June, the Advisory Committee on Immunization Practices (ACIP), a highly influential panel of outside advisors to the US Centers for Disease Control and Prevention (CDC), reviewed data regarding the risks and benefits of the 2 rotavirus vaccines currently approved for the prevention of severe gastroenteritis and its sequelae. Rotavirus vaccination has been recommended for infants in the United States since 2006; in July, it was added to the national immunization schedule in the United Kingdom. Since their addition to the US vaccination schedule, both vaccines, Merck’s RotaTeq and GlaxoSmithKline’s Rotarix, have been associated with a slightly elevated risk of intussusception. According to CDC estimates, 45 to 213 excess cases of intussusception are anticipated in each fully vaccinated US birth cohort by 5 years of age, the majority of which would require hospitalization.2 Following its most extensive review to date of evidence regarding rotavirus vaccination programs in the United States and internationally, the ACIP reaffirmed at its June meeting its earlier conclusion that the benefits of vaccination greatly outweigh its risks, an assessment shared by the CDC. These benefits include the prevention of an estimated 169 949 emergency department visits, 53 444 hospitalizations, and 14 deaths in each US birth cohort.3 Accordingly, no change was made to the committee’s recommendation that either rotavirus vaccine be administered routinely to US infants beginning at 2 months of age. The CDC and its advisors continued to endorse further monitoring of the association between both vaccines and intussusception and ongoing intussusception education efforts directed to providers and parents. Expert consultants to the World Health Organization reached similar conclusions in 2011. The ACIP’s recent attention to the risk of intussusception associated with rotavirus vaccination is not new. In 1998-1999, this concern was among the primary items on the committee’s agenda as it assessed the risks of the first licensed rotavirus vaccine, Wyeth’s RotaShield. Its use was suspended in the United States in July 1999 following a series of reports of intussusception among vaccine recipients in the months after its approval.4 Three months later, the ACIP withdrew its recommendation for RotaShield based on results of epidemiological research that confirmed an increased risk of intussusception among recipients of the vaccine.5,6 The vaccine was not used again in the United States, the only country where it had been licensed, nor was subsequent research conducted to assess its risks and benefits in other nations, including those where the burden of rotavirusrelated disease was greatest. Although the slight risk of intussusception associated with the present generation of rotavirus vaccines— one thought to be far smaller than that of RotaShield—is worrisome to health officials, the US and global public health communities have approached this issue with a clear appreciation of the lessons and legacy of RotaShield. Prior to their approval, deliberately large clinical trials gave researchers and regulators greater confidence that the new products did not share a risk of intussusception comparable in magnitude to that of the first rotavirus vaccine. Although an increased risk was not detected prior to the approval of the current vaccines despite these trial sizes, heightened awareness of the potential for intussusception among vaccine recipients facilitated the prompt identification of this risk and the establishment of ongoing safety surveillance as part of national and international vaccination programs. The multihour discussion of rotavirus vaccines and intussusception at the ACIP’s June meeting ended with an extensive review of evidence regarding the risks and benefits of continuing routine vaccination of children.2 This presentation included detailed estimates of the anticipated reduction in rotavirus infections and their clinical sequelae for each US birth cohort, as well as the expected additional cases of intussusception attributable to the vaccine. This session was the clearest departure from the committee’s public deliberations regarding RotaShield 14 years earlier. Then, the ACIP’s proceedings included no public discussion of the specific risks and benefits of resuming rotavirus vaccination in the United States, even during the daylong session in October 1999 that culminated in the committee’s vote to withdraw its recommendation for the vaccine.4 The implication of the ACIP’s deliberations and the public statements from the CDC at the time was that the confirmation of a severe risk associated with RotaShield was sufficient to permanently halt its use, regardless of the potential benefits of the vaccine. In contrast, the frank discussion and comparison of both risks and benefits by US and international public health authorities as part of their continued endorsement of rotavirus vaccination in 2013 represent a more credible and responsible approach to evaluating medical interventions and justifying subsequent policy deciVIEWPOINT