Optimal Design of Population-Level Financial Incentives of Influenza Vaccination for the Elderly.

OBJECTIVES: To identify how monetary incentives affect influenza vaccination uptake rate using a randomized control experiment and to subsequently design an optimal incentive program in Singapore, a high-income country with a market-based healthcare system. METHODS: 4000 people aged ≥65 were randomly assigned to 4 treatment groups (1000 each) and were offered a monetary incentive (in shopping vouchers) if they chose to participate. The baseline group was invited to complete a questionnaire with incentives of 10 Singapore dollars (SGD; where 1 SGD ≈ 0.73 USD), whereas the other three groups were invited to complete the questionnaire and be vaccinated against influenza at their own cost of around 32 SGD, in return for incentives of 10, 20, or 30 SGD. RESULTS: Increasing the total incentive for vaccination and reporting from 10 to 20 SGD increased participation in vaccination from 4.5% to 7.5% (P < .001). Increasing the total incentive from 20 to 30 SGD increased the participation rate to 9.2%, but this was not statistically significantly different from a 20-SGD incentive. The group of nonworking elderly were more sensitive to changes in incentives than those who worked. In addition to working status, the effects of increasing incentives on influenza vaccination rates differed by ethnicity, socio-economic status, household size, and a measure of social resilience. There were no significant differential effects by age group, gender, or education, however. The cost of the program per completed vaccination under a 20-SGD incentive is 36.80 SGD, which was the lowest among the three intervention arms. For a hypothetical population-level financial incentive program to promote influenza vaccination among the elderly, accounting for transmission dynamics, an incentive between 10 and 20 SGD minimizes the cost per completed vaccination from both governmental and health system perspectives. CONCLUSIONS: Appropriate monetary incentives can boost influenza vaccination rates. Increasing monetary incentives for vaccination from 10 to 20 SGD can improve the influenza vaccination uptake rate, but further increasing the monetary incentive to 30 SGD results in no additional gains. A partial incentive may therefore be considered to improve vaccination coverage in this high-risk group.

Estimating the Effect of a National Pharmacy-Led Influenza Vaccination Voucher Program on Morbidity, Mortality, and Costs.

BACKGROUND: Influenza (also known as "flu") is estimated to cause between 12,000 and 79,000 deaths annually. Vaccinations are beneficial in preventing influenza cases and reducing the likelihood of severe outcomes. Unfortunately, vaccination coverage is low among uninsured populations. Removing the cost barrier can help increase vaccination coverage in this group, averting flu cases and related morbidity and costs. OBJECTIVE: To model the potential effect of providing no-cost flu vaccinations to uninsured individuals on influenza-related morbidity, mortality, and costs. METHODS: In collaboration with the Department of Health and Human Services and local agencies, Walgreens pharmacies provided free flu vaccinations through a nationwide voucher distribution program. We calculated the redemption rate, potentially averted cases, and estimated cost savings for the 2015-2016 and 2016-2017 flu seasons. Using incidence and vaccine effectiveness estimates from the Centers for Disease Control and Prevention, we calculated the rate of influenza in the general population and the estimated cases averted based on the number of redeemed vouchers. We applied patient age along with parameters from published studies to estimate averted ambulatory care visits, hospitalizations, mortality, productively losses, and overall related costs. RESULTS: During the 2015-2016 flu season, the pharmacy chain distributed 600,000 vouchers with a redemption rate of 52.3%, resulting in 314,033 flu vaccinations. Improvements were subsequently made to the distribution process to increase utilization rates. There were 400,000 vouchers distributed during the 2016-2017 season with a higher redemption rate of 87.2%, resulting in 348,924 flu vaccinations. The estimated number of potentially averted cases was higher during the 2016-2017 season (13,347) than the 2015-2016 season (11,537) due to a higher redemption rate and increased flu activity. Taken together, we estimated that 8,621 ambulatory care visits, 314 hospitalizations, and 15 deaths were averted due to the flu voucher program. Averted health care costs totaled $937,494 in ambulatory care visits and $3,510,055 in hospitalizations. Averted productivity losses ranged from $4,473,509 to $14,613,502. CONCLUSIONS: This study demonstrates the effectiveness of a pharmacy-led partnership with local community-based organizations to promote flu vaccinations among uninsured individuals. Our model found that a no-cost flu voucher program has the potential to reduce influenza-related morbidity, mortality, and costs. DISCLOSURES: This study was funded by Walgreen Co. All authors are employees of Walgreen Co. and affiliated with Walgreens Center for Health and Wellbeing Research. Findings from this study were presented as a podium presentation at the Academy of Managed Care Pharmacy Nexus 2018; October 22-25, 2018; Orlando, FL.

Stopping the HPV vaccine crisis in Japan: Quantifying the benefits and risks of HPV vaccination in quality-adjusted life-years for appropriate decision-making.

BACKGROUND: The human papilloma virus (HPV) vaccination coverage rate in Japan has dropped dramatically from more than 70% to less than 1% since 2013. With conflicting information and a lack of quantification of the benefits and risks of the HPV vaccine, parents have been hindered in making their decision. We quantified the benefits and risks of the HPV vaccine in terms of quality-adjusted life-years (QALYs), to help their informed decision. METHOD: A literature search was performed to determine the incidence and burden of each outcome in a decision tree model. The benefits and the risks of the HPV vaccination were determined in QALY change with a sensitivity analysis. RESULT: The benefits of the HPV vaccine in terms of QALYs gained were 703.72, 14.45, and 30.83/100,000 persons for cervical cancer, cervical intraepithelial neoplasm 3 (CIN 3), and genital warts, respectively. The QALY loss due to acute adverse reactions, chronic adverse reactions without assistance needs, and chronic adverse reactions with assistance needs were 0.07, 5.83, and 5.82/100,000 persons, respectively. The risk/benefit ratio in QALY change in the base case was 0.0156. In all scenarios, the benefit of the HPV vaccine was significantly greater than the risk. CONCLUSION: The benefits are much greater than the risks, even if it is assumed that all reported adverse events were due to the vaccination. The Japanese government and health care providers should immediately recommend the HPV vaccine to all adolescent girls irrespective of any causal links between the vaccine and reported adverse events.

Cluster anxiety-related adverse events following immunization (AEFI): An assessment of reports detected in social media and those identified using an online search engine.

BACKGROUND: Adverse events following immunization (AEFI) arising from anxiety have rarely been reported as a cluster(s) in the setting of a mass vaccination program. Reports of clusters of anxiety-related AEFIs are understudied. Social media and the web may be a resource for public health investigators. METHODS: We searched Google and Facebook separately from Atlanta and Geneva to identify reports of cluster anxiety-related AEFIs. We reviewed a sample of reports summarizing year, country/setting, vaccine involved, patient symptoms, clinical management, and impact to vaccination programs. RESULTS: We found 39 reports referring to 18 unique cluster events. Some reports were only found based on the geographic location from where the search was performed. The most common vaccine implicated in reports was human papillomavirus (HPV) vaccine (48.7%). The majority of reports (97.4%) involved children and vaccination programs in school settings or as part of national vaccination campaigns. Five vaccination programs were reportedly halted because of these cluster events. In this study, we identified 18 cluster events that were not published in traditional scientific peer-reviewed literature. CONCLUSIONS: Social media and online search engines are useful resources for identifying reports of cluster anxiety-related AEFIs and the geographic location of the researcher is an important factor to consider when conducting these studies. Solely relying upon traditional peer-reviewed journals may seriously underestimate the occurrence of such cluster events.

Challenges in conducting a community-based influenza vaccine trial in a rural community in northern India.

Evidence on influenza vaccine effectiveness from low and middle countries (LMICs) is limited due to limited institutional capacities; lack of adequate resources; and lack of interest by ministries of health for influenza vaccine introduction. There are concerns that the highest ethical standards will be compromised during trials in LMICs leading to mistrust of clinical trials. These factors pose regulatory and operational challenges to researchers in these countries. We conducted a community-based vaccine trial to assess the efficacy of live attenuated influenza vaccine and inactivated influenza vaccine in rural north India. Key regulatory challenges included obtaining regulatory approvals, reporting of adverse events, and compensating subjects for trial-related injuries; all of which were required to be completed in a timely fashion. Key operational challenges included obtaining audio-visual consent; maintaining a low attrition rate; and administering vaccines during a narrow time period before the influenza season, and under extreme heat. We overcame these challenges through advanced planning, and sustaining community engagement. We adapted the trial procedures to cope with field conditions by conducting mock vaccine camps; and planned for early morning vaccination to mitigate threats to the cold chain. These lessons may help investigators to confront similar challenges in other LMICs.

Rotavirus vaccination in central Europe.

Each year, rotavirus (RV) infection is the leading cause of acute gastroenteritis requiring hospitalisation and of nosocomially transmitted diseases in children younger than 5 years across Central European Vaccination Awareness Group (CEVAG) countries; however, inadequate surveillance systems and lack of routine RV testing still exist in most CEVAG countries, making it difficult to accurately assess the present burden of acute RV gastroenteritis in the younger population. Furthermore, routine immunisation of infants with RV vaccines has not been implemented, and no official and uniform recommendations exist in most of the countries in these territories. The present study provides CEVAG country-specific estimates of the disease burden of RV gastroenteritis among the youngest population and presents evidence-based advice on the use of RV vaccines in the region, while providing a framework for vaccination at the national level.

Bad medicine: prescription drugs, preemption, and the potential for a no-fault fix.

For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA's regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries--even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs' lawyers alike.

Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines.

Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.

Economics of cardiac adverse events after smallpox vaccination: lessons from the 2003 US Vaccination Program.

Of >39,000 civilian public health responders vaccinated against smallpox in 2003, 203 reported cardiovascular adverse events (CAEs). An association exists between the US vaccinia strain and myocarditis and/or pericarditis ("myo/pericarditis" [MP]). Other associations are inconclusive. We used surveillance and follow-up survey data of CAE case patients to estimate the resources used during the 2003 smallpox vaccination program and used a probabilistic model to estimate the potential costs of CAEs in a mass vaccination campaign. For every million adult vaccinees, 3001 CAEs (including 351 MP cases) would occur, with >92% in revaccinees. CAEs would require a median of 5934 outpatient visits, 1786 emergency department visits, 533 days in general wards, 132 days in intensive care units, 5484 cardiac enzymes tests, 3504 electrocardiograms, 3049 chemistry tests, 2828 complete blood counts, and 1444 transthoracic echocardiograms, among other procedures. CAEs would reduce productivity (15,969 work days lost) and cost $11 per vaccinee. In a mass vaccination campaign, the care of a sizable number of CAEs would be resource intensive.

The Smallpox Vaccine Injury Compensation Program.

In January 2003, the Secretary of the US Department of Health and Human Services (DHHS) announced that certain individuals should receive smallpox vaccine or other countermeasures to be prepared to serve the civilian population in the event of a smallpox bioterrorism event. In April 2003, Congress passed and the President signed the Smallpox Emergency Personnel Protection Act of 2003. This act created the Smallpox Vaccine Injury Compensation Program to provide medical and lost employment income coverage as a payer of last resort to persons who sustain a covered medical injury as a direct result of receiving smallpox vaccination voluntarily under a DHHS-approved smallpox emergency response plan. As of September 2006, 62 persons had requested benefits, of whom 19 had been determined to be medically eligible, 27 were denied benefits, and 16 submitted the request after the legislatively defined filing deadline.

Update on the National Vaccine Injury Compensation Program.

The National Childhood Vaccine Injury Act of 1986, as amended, established the Vaccine Injury Compensation Program (VICP). The VICP went into effect on October 1, 1988 and is a Federal "no-fault" system designed to compensate individuals, or families of individuals, who have been injured by covered vaccines. From 1988 until July 2006, a total of 2531 non-autism/thimerosal and 5030 autism/thimerosal claims were made to the VICP. The compensation paid for the non-autism/thimerosal claims from 1988 until 2006 was $902,519,103.37 for 2542 awards. There was no compensation for any of the autism/thimerosal claims. On the basis of the deaths and extensive suffering to patients and families from the adverse reactions to vaccines, all physicians must provide detailed information in the Vaccine Information Statement to the patient or the parent or legal guardian of the child about the potential dangers of vaccines as well as the VICP.

Health benefits, risks, and cost-effectiveness of influenza vaccination of children.

We estimated cost-effectiveness of annually vaccinating children not at high risk with inactivated influenza vaccine (IIV) to range from US $12,000 per quality-adjusted life year (QALY) saved for children ages 6-23 months to $119,000 per QALY saved for children ages 12-17 years. For children at high risk (preexisting medical conditions) ages 6-35 months, vaccination with IIV was cost saving. For children at high risk ages 3-17 years, vaccination cost $1,000-$10,000 per QALY. Among children notat high risk ages 5-17 years, live, attenuated influenza vaccine had a similar cost-effectiveness as IIV. Risk status was more important than age in determining the economic effects of annual vaccination, and vaccination was less cost-effective as the child's age increased. Thus, routine vaccination of all children is likely less cost-effective than vaccination of all children ages 6-23 months plus all other children at high risk.

The case against universal varicella vaccination.

In 1995, the United States became the first country to implement a Universal Varicella Vaccination Program. Several questions remain: Is the varicella (chickenpox) vaccine needed? Is it cost effective as a routine immunization for all susceptible children? Or is it more beneficial for the disease to remain endemic so that adults may receive periodic exogenous exposures (boosts) that help suppress the reactivation of herpes zoster (shingles). In addition, as vaccination coverage becomes widespread, does loss of immunologic boosting cause a decline in vaccine efficacy and result in a reduced period of immunity? Scientific literature regarding safety of the varicella vaccine and its associated cost-benefit analysis have often reported optimistic evaluations based on ideal assumptions. Deleterious outcomes and their associated costs must be included when making a circumspect assessment of the Universal Varicella Vaccination Program.