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.

Understanding the Factors Influencing Health Care Provider Recommendations about Adolescent Vaccines: A Proposed Framework.

Health care provider recommendations are among the most important factors influencing parents' decisions to vaccinate their adolescents. However, delivery of high-quality health care provider recommendations for vaccination is not universal. There is wide variation in the strength, timeliness and consistency of the delivery of recommendations for all adolescent vaccines. The factors that influence health care providers' recommendations are multi-level and can be conceptualized in much the same way as vaccine acceptance among parents. Health care providers are influenced by their own attitudes and beliefs about a vaccine and also by the patient they are treating and by the community in which they practice as well as state and national level vaccine policy. We propose a multi-level framework for understanding the factors that influence health care providers' recommendations at the individual, interpersonal and community level to both develop and adapt interventions to improve providers' recommendations.

Promoting COVID-19 vaccine acceptance: recommendations from the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA.

Since the first case of COVID-19 was identified in the USA in January, 2020, over 46 million people in the country have tested positive for SARS-CoV-2 infection. Several COVID-19 vaccines have received emergency use authorisations from the US Food and Drug Administration, with the Pfizer-BioNTech vaccine receiving full approval on Aug 23, 2021. When paired with masking, physical distancing, and ventilation, COVID-19 vaccines are the best intervention to sustainably control the pandemic. However, surveys have consistently found that a sizeable minority of US residents do not plan to get a COVID-19 vaccine. The most severe consequence of an inadequate uptake of COVID-19 vaccines has been sustained community transmission (including of the delta [B.1.617.2] variant, a surge of which began in July, 2021). Exacerbating the direct impact of the virus, a low uptake of COVID-19 vaccines will prolong the social and economic repercussions of the pandemic on families and communities, especially low-income and minority ethnic groups, into 2022, or even longer. The scale and challenges of the COVID-19 vaccination campaign are unprecedented. Therefore, through a series of recommendations, we present a coordinated, evidence-based education, communication, and behavioural intervention strategy that is likely to improve the success of COVID-19 vaccine programmes across the USA.

COVID-19 vaccine perceptions in the initial phases of US vaccine roll-out: an observational study on reddit.

BACKGROUND: Open online forums like Reddit provide an opportunity to quantitatively examine COVID-19 vaccine perceptions early in the vaccine timeline. We examine COVID-19 misinformation on Reddit following vaccine scientific announcements, in the initial phases of the vaccine timeline. METHODS: We collected all posts on Reddit (reddit.com) from January 1 2020 - December 14 2020 (n=266,840) that contained both COVID-19 and vaccine-related keywords. We used topic modeling to understand changes in word prevalence within topics after the release of vaccine trial data. Social network analysis was also conducted to determine the relationship between Reddit communities (subreddits) that shared COVID-19 vaccine posts, and the movement of posts between subreddits. RESULTS: There was an association between a Pfizer press release reporting 90% efficacy and increased discussion on vaccine misinformation. We observed an association between Johnson and Johnson temporarily halting its vaccine trials and reduced misinformation. We found that information skeptical of vaccination was first posted in a subreddit (r/Coronavirus) which favored accurate information and then reposted in subreddits associated with antivaccine beliefs and conspiracy theories (e.g. conspiracy, NoNewNormal). CONCLUSIONS: Our findings can inform the development of interventions where individuals determine the accuracy of vaccine information, and communications campaigns to improve COVID-19 vaccine perceptions, early in the vaccine timeline. Such efforts can increase individual- and population-level awareness of accurate and scientifically sound information regarding vaccines and thereby improve attitudes about vaccines, especially in the early phases of vaccine roll-out. Further research is needed to understand how social media can contribute to COVID-19 vaccination services.

Assessing COVID-19 Prevention Strategies to Permit the Safe Opening of Residential Colleges in Fall 2021.

BACKGROUND: Effective vaccines, improved testing technologies, and decreases in COVID-19 incidence prompt an examination of the choices available to residential college administrators seeking to safely resume in-person campus activities in fall 2021. OBJECTIVE: To help college administrators design and evaluate customized COVID-19 safety plans. DESIGN: Decision analysis using a compartmental epidemic model to optimize vaccination, testing, and other nonpharmaceutical interventions depending on decision makers' preferences, choices, and assumptions about epidemic severity and vaccine effectiveness against infection, transmission, and disease progression. SETTING: U.S. residential colleges. PARTICIPANTS: Hypothetical cohort of 5000 persons (students, faculty, and staff) living and working in close proximity on campus. MEASUREMENTS: Cumulative infections over a 120-day semester. RESULTS: Under base-case assumptions, if 90% coverage can be attained with a vaccine that is 85% protective against infection and 25% protective against asymptomatic transmission, the model finds that campus activities can be resumed while holding cumulative cases below 5% of the population without the need for routine, asymptomatic testing. With 50% population coverage using such a vaccine, a similar cap on cumulative cases would require either daily asymptomatic testing of unvaccinated persons or a combination of less frequent testing and resumption of aggressive distancing and other nonpharmaceutical prevention policies. Colleges returning to pre-COVID-19 campus activities without either broad vaccination coverage or high-frequency testing put their campus population at risk for widespread viral transmission. LIMITATION: Uncertainty in data, particularly vaccine effectiveness (preventive and transmission); no distinguishing between students and employees; and assumes limited community intermixing. CONCLUSION: Vaccination coverage is the most powerful tool available to residential college administrators seeking to achieve a safe return to prepandemic operations this fall. Given the breadth of potential outcomes in the face of uncontrollable and uncertain factors, even colleges with high vaccination rates should be prepared to reinstitute or expand testing and distancing policies on short notice. PRIMARY FUNDING SOURCE: National Institute on Drug Abuse.

Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.

Policy Points Food and Drug Administration (FDA) advisory committee recommendations and the agency's final actions exhibit high rates of agreement, with cases of disagreement tending to reflect the proposed action type and degree of advisory committee consensus. In the case of disagreements, the FDA tended to be less likely than its advisory committees to approve new products, approve new supplemental indications, or enact new safety changes. These findings raise important issues regarding the factors that differentially shape decision making by advisory committees and the FDA as an agency, including institutional or reputational concerns. CONTEXT: The Food and Drug Administration (FDA) convenes advisory committees to provide external scientific counsel on potential agency actions and to inform regulatory decision making. The degree to which advisory committees and their respective agency divisions disagree on recommendations has not been well characterized across product and action types. METHODS: We examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015. We classified the 376 voting meetings in that period by medical product, regulatory, and advisory committee meeting characteristics. We used multivariable logistic regression to determine the associations between these characteristics and discordance between the advisory committee's recommendations and the FDA's final actions. FINDINGS: Twenty-two percent of the FDA's final actions were discordant with the advisory committee's recommendations. Of these, 75% resulted in the FDA making more restrictive decisions after favorable committee recommendations, and 25% resulted in the agency making less restrictive decisions after unfavorable committee recommendations. Discordance was associated with lower degrees of advisory committee consensus and was more likely for agency actions focused on medical product safety than for novel approvals or supplemental indications. Statements by public speakers, advisory committee conflicts of interest, and media coverage were not associated with discordance between the committee and the agency. CONCLUSIONS: The FDA disagrees with the recommendation of its advisory committees a minority of the time, and in these cases it tends to be less likely to approve new products or supplemental indications and take safety actions. Deviations from recommendations thus offer an opportunity to understand the factors influencing decisions made by both the agency and its expert advisory groups.

The Spanish Flu, Epidemics, and the Turn to Biomedical Responses.

A century ago, nonpharmaceutical interventions such as school closings, restrictions on large gatherings, and isolation and quarantine were the centerpiece of the response to the Spanish Flu. Yet, even though its cause was unknown and the science of vaccine development was in its infancy, considerable enthusiasm also existed for using vaccines to prevent its spread. This desire far exceeded the scientific knowledge and technological capabilities of the time. Beginning in the early 1930s, however, advances in virology and influenza vaccine development reshaped the relative priority given to biomedical approaches in epidemic response over traditional public health activities. Today, the large-scale implementation of nonpharmaceutical interventions akin to the response to the Spanish Flu would face enormous legal, ethical, and political challenges, but the enthusiasm for vaccines and other biomedical interventions that was emerging in 1918 has flourished. The Spanish Flu functioned as an inflection point in the history of epidemic responses, a critical moment in the long transition from approaches dominated by traditional public health activities to those in which biomedical interventions are viewed as the most potent and promising tools in the epidemic response arsenal.

Kindergarten Vaccination Status in California After Changes to Medical Exemption Policy.

This study evaluates changes in medical exemptions and geographic distribution of kindergarteners in California not up to date on vaccination after changes to state legislation.

The Missions of National Commissions: Mapping the Forms and Functions of Bioethics Advisory Bodies.

The findings, conclusions, and recommendations of national ethics commissions (NECs) have received considerable attention throughout the 40-year history of these groups in the United States and worldwide. However, the procedures or types of argument by which these bodies arrive at their decisions have received far less scrutiny. This paper explores how the diversity of ethical principles, concepts, or theories is featured in publications or decisions of these bodies, with particular emphasis on the need for NECs to be inclusive of pluralist positions that typically exist in contemporary democracies. The discussion is centered on the extent to which NECs may focus on providing focal frameworks, primarily framing the ethical issues at stake, or normative frameworks, additionally providing transparent justifications for any conclusions and recommendations that are made. The structure allows for assessments of the relative merits and drawbacks of different approaches in both theory and practice.

Excess Death Rates for Republican and Democratic Registered Voters in Florida and Ohio During the COVID-19 Pandemic.

Importance: There is evidence that Republican-leaning counties have had higher COVID-19 death rates than Democratic-leaning counties and similar evidence of an association between political party affiliation and attitudes regarding COVID-19 vaccination; further data on these rates may be useful. Objective: To assess political party affiliation and mortality rates for individuals during the initial 22 months of the COVID-19 pandemic. Design, Setting, and Participants: A cross-sectional comparison of excess mortality between registered Republican and Democratic voters between March 2020 and December 2021 adjusted for age and state of voter registration was conducted. Voter and mortality data from Florida and Ohio in 2017 linked to mortality records for January 1, 2018, to December 31, 2021, were used in data analysis. Exposures: Political party affiliation. Main Outcomes and Measures: Excess weekly deaths during the COVID-19 pandemic adjusted for age, county, party affiliation, and seasonality. Results: Between January 1, 2018, and December 31, 2021, there were 538 159 individuals in Ohio and Florida who died at age 25 years or older in the study sample. The median age at death was 78 years (IQR, 71-89 years). Overall, the excess death rate for Republican voters was 2.8 percentage points, or 15%, higher than the excess death rate for Democratic voters (95% prediction interval [PI], 1.6-3.7 percentage points). After May 1, 2021, when vaccines were available to all adults, the excess death rate gap between Republican and Democratic voters widened from -0.9 percentage point (95% PI, -2.5 to 0.3 percentage points) to 7.7 percentage points (95% PI, 6.0-9.3 percentage points) in the adjusted analysis; the excess death rate among Republican voters was 43% higher than the excess death rate among Democratic voters. The gap in excess death rates between Republican and Democratic voters was larger in counties with lower vaccination rates and was primarily noted in voters residing in Ohio. Conclusions and Relevance: In this cross-sectional study, an association was observed between political party affiliation and excess deaths in Ohio and Florida after COVID-19 vaccines were available to all adults. These findings suggest that differences in vaccination attitudes and reported uptake between Republican and Democratic voters may have been factors in the severity and trajectory of the pandemic in the US.