Vaccination is an important tool for handling healthcare programs both in developed and developing countries. The current global scenario calls for a more‐efficacious, acceptable, cost‐effective and reliable method of immunization for many fatal diseases. It is hoped that the adoption of oral vaccines will help to provide an effective vaccination strategy, especially in developing countries. Mucosal immunity generated by oral vaccines can serve as a strong first line of defense against most of the pathogens infecting through the mucosal lining. Advances (...) in elucidating the mechanism of action of oral vaccines will facilitate the design of more effective, new generation vaccines. There are promising developments in the use of different agents to effectively deliver the vaccine candidate. It is hoped that ongoing research may be able to set another cardinal point, after polio vaccine, in eradicating infectious diseases. BioEssays 29:591–604, 2007. © 2007 Wiley Periodicals, Inc. (shrink)

This paper provides an overview of the development of typhus vaccines between the first and second world wars. It is shown that there was a shift in the classification of the causal Rickettsiae from being classed as bacteria to being conceptualised as a type of virus. This 'paradigm switch' stimulated interest in the possibility of producing an effective medicine.

This chapter contains sections titled: Vaccine Hunting Horrible Harry Into the Lab Necessary Questions.

For over a century, a foreign national seeking permission to immigrate to the U.S. could have her application for immigration denied on the ground that she suffers from a serious contagious disease. For just under two decades, a foreign national seeking permission to immigrate could also have her application denied on the ground that she has not been vaccinated against each of a list of vaccination-preventable diseases. Two recently developed moral justifications for the use of such “vaccination-related exclusion criteria” have (...) focused on (a) the right and need of a society to prevent the spread of disease to others and (b) the public good of developing and protecting herd immunity. Herein I accept these two general justifications—especially as they are developed by Mark Navin—and explore their limits. In particular, with a focus on the recently developed vaccine against several strains of HPV, as well the short-lived requirement by the CDC that it, too, be required of prospective immigrants, I argue that neither of the two main justifications for the use of vaccination-related exclusion criteria support their use for diseases such as HPV (or even HIV), the transmission of which, unlike airborne diseases such as measles, pertussis and polio, is subject to a considerable degree of individual control. (shrink)

Public health law courses typically focus a good deal of attention on two related topics: the duty of government agencies to control the spread of communicable diseases and their use of the police power to do so. While governments sometimes take forceful actions in responding to disease outbreaks, they can also act to prevent their occurrence. Indeed, one of the great triumphs of public health in the 20th century was the development of vaccines and their widespread use, which seemed (...) on course to relegate many formerly crippling or deadly diseases to the history books. Particular success occurred with vaccinations against childhood diseases such as polio, smallpox, and measles, outbreaks of which once routinely closed schoolrooms, playgrounds, and community swimming pools. By the last quarter of the century, completion of an elaborate schedule of immunizations was not merely the standard in pediatric practice but an official requirement for school enrollment. As a result, the range of communicable diseases that had once terrified parents had become threats to be feared only in memory. (shrink)

The aim of this paper is to introduce the one hundred years of vaccination that has passed since Louis Pasteur first coined this generic term. According to the late Jonas Salk, vaccinology is a science encompassing all aspects of vaccine from its conception in the laboratory to its production by companies and its application and distribution in the field. In this historical survey I explore how vaccination never consisted of a simple and uniform application of a rational model, but (...) rather diverged along various pathways, several of which were discarded in retrospect as being hazardous, and I analyse the ongoing interplay between rational and inventive thinking. (shrink)

The theory that AIDS originated from contaminated polio vaccines raises a number of challenging issues with ethical dimensions. The Journal of Medical Ethics dealt with a submission about the theory a decade ago; subsequent developments have raised further issues. Four areas of contention are addressed: whether the theory should be investigated; whether anyone should be blamed; whether defamation actions are appropriate, and whether the scientific community has a responsibility to examine unorthodox theories.

In this essay, we defend the design of the Salk polio vaccine trial and try to put some limits on the role schemata should play in designing clinical research studies. Our presentation is structured as a response to de Freitas and Pietrobon who identified the CONSORT statement as a schema that would have, had it existed at the time, ruled out the design of the Salk polio vaccine trial of 1954 in favor of a completely randomized (...) controlled clinical trial. We argue that large-scale public health interventions often require evidence beyond simple efficacy, the limit of what an RCT can provide, and that the design actually adopted for the Salk trial represented a reasonable—albeit imperfect—compromise. This is of more than historical interest in that many contemporary studies are of the scale and scope to require a more pragmatic, rather than explanatory, approach to study design. (shrink)

As compared with conventional vaccine production systems, plant-made vaccines are said to enjoy a range of advantages including cost of production and ease of storage for distribution in developing countries. In this article, we introduce the science of PMV production, and address ethical issues associated with development and clinical testing of PMVs within three interrelated domains: PMVs as transgenic plants; PMVs as clinical research materials; and PMVs as agents of global health. We present three conclusions: first, while many (...) of the ethical issues raised by PMVs are familiar, PMVs add a new dimension to old issues, and raise some novel issues for ethicists and policy-makers; secondly, it is premature to promise broad applicability of PMVs across the developing world without having demonstrated their feasibility; thirdly, in particular, proponents of PMVs as a solution to global health problems must, as a condition of the ethical conduct of their research, define the commercial feasibility of PMVs for distribution in the developing world. (shrink)

In response to the COVID-19 pandemic, states have funneled exceptional amounts of public funding into research and development of diagnostics, treatments and vaccines to help fight the virus. In th...

Vaccine refusal harms and risks harming innocent bystanders. People are not entitled to harm innocents or to impose deadly risks on others, so in these cases there is nothing to be said for the right to refuse vaccination. Compulsory vaccination is therefore justified because non-vaccination can rightly be prohibited, just as other kinds of harmful and risky conduct are rightly prohibited. I develop an analogy to random gunfire to illustrate this point. Vaccine refusal, I argue, is morally similar (...) to firing a weapon into the air and endangering innocent bystanders. By re-framing vaccine refusal as harmful and reckless conduct my aim is to shift the focus of the vaccine debate from non-vaccinators’ religious and refusal rights to everyone else’s rights against being infected with contagious illnesses. Religious freedom and rights of informed consent do not entitle non-vaccinators to harm innocent bystanders, and so coercive vaccination requirements are permissible for the sake of the potential victims of the anti-vaccine movement. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Fetal Tissue ResearchMary Carrington Coutts (bio)I. IntroductionThe use of tissue from fetal remains for transplantation and biomedical research has become a controversial issue in recent years, involving scientists, doctors, patients, and the federal government. Fetal tissue is potentially useful in a wide range of treatments for a number of serious diseases, some of them affecting millions of people. Despite the promise, transplantation research using fetal tissue from induced abortion (...) slowed dramatically in the U.S. in 1988, when a moratorium was declared on federal funding for such research involving humans. That moratorium was lifted by President Clinton on January 21, 1993. Though the future of fetal tissue transplantation research is brighter, public debate on the issue is likely to continue, exacerbated by the "acrimonious abortion debate" (VI, Post 1991, p. 14).Using fetal tissue in biomedical research and in transplantation is not a new practice. As early as 1928 unsuccessful attempts were made to transplant fetal pancreas cells into diabetics (VII, Fichera 1928). Fetal tissue was used effectively in biomedical research during the 1950s, and was instrumental in the culture of the polio virus, which led to the development of the polio vaccine. Fetal tissue cultures were also essential in the development of the rubella vaccine, and continue to be used in virology research. Transplantation of fetal thymus cells into patients with DiGeorge Syndrome has been recognized as effective therapy since the late 1960s.Many of the therapeutic applications involving fetal tissue are still experimental, so it is difficult to pinpoint fetal tissue transplantation's therapeutic potential. One promising application is the transplantation of human fetal brain cells into the substantia nigra of patients with Parkinson's disease to restore motor function. Fetal neural transplants have also shown promise for patients suffering from Alzheimer's disease, spinal cord and other neural tissue injuries, and possibly some forms of cortical blindness. Fetal liver cells may be useful for treatment of some kinds of bone marrow disease seen in leukemia and aplastic anemia patients. [End Page 81] Fetal tissue transplantation may also help those suffering from blood clotting disorders, such as sickle cell anemia, thalassemia, and hemophilia. Fetal pancreatic tissue has potential applications in the treatment of diabetes, especially juvenile onset diabetes. Human gene therapy may also employ embryonic and early fetal cells.The Center for Biomedical Ethics at the University of Minnesota reports that more than 1,000 patients have received transplanted fetal tissue worldwide. Countries where fetal tissue transplantation has occurred include: Australia, Canada, China, the Commonwealth of Independent States (formerly the U.S.S.R.), Cuba, Czechoslovakia, Finland, France, Germany, Great Britain, Hungary, India, Italy, Mexico, Norway, Spain, Sweden, and Yugoslavia (IV, Vawter 1992, p. 2; I, Spain 1988; VII, Reinikainen 1989).Fetal tissue has unique characteristics that make it especially valuable in some treatments. Fetal cells develop much faster than adult cells, hastening the therapeutic effect—a potentially significant benefit for gravely ill patients. They are also less likely to be rejected by transplant recipients because they are less antigenic than adult cells. This reduces the need for the exact tissue matches that can be so difficult to obtain. Fetal tissue is also easier to culture and proliferates more readily than comparable adult tissue. Furthermore, fetal tissue is in greater supply, due to the number of elective abortions.Questions about the use of fetuses and fetal tissue in biomedical research were raised in the United States in the early 1970s. Between 1969 and 1973, all 50 states enacted the Uniform Anatomical Gift Act, allowing for the donation of all or part of the body of a dead fetus for research or therapeutic research. Prospects for the use of fetal tissue increased after the Supreme Court decision in Roe v. Wade legalized abortion. As the availability of fetal tissue increased so did the concern over the potential for controversial research on living, soon-to-be-aborted fetuses, and anxiety over maltreatment of dead abortuses. Vivid examples include Geoffrey Chamberlain's 1968 report of an experiment on a fetus of 26 weeks gestational age. Delivered by hysterotomy from a 14-year-old patient, the fetus was attached to an "artificial placenta" and kept alive for more than... (shrink)

This article is about the ways in which representations of users’ bodies mediate in the designers’ configuration of anti-fertility vaccines and their future users. Anti-fertility vaccines are a novel and not yet available method to regulate fertility. The researchers involved claim that anti-fertility vaccines can be developed for both men and women. But in the material and political specificities of the research contexts, representations of male bodies as users have disappeared, and most research involves the development of a method (...) to be used by women. Anti-fertility vaccines therefore provide an opportunity to study when the sex of future users is deemed relevant by the researchers. This article explores how the fact that most anti-fertility vaccines are developed for female users can be explained without resorting to biological or cultural determinism. How much room for maneuver did the researchers have in defining the vaccines and their users? (shrink)

Recombinant DNA technology has been used to engineer vaccinia virus genetically into a eukaryotic expression vector. An exciting outcome of these gene‐splicing techniques is that after the insertion of one or more genes which encode the information for antigens responsible for conferring immunity toward an infectious disease, vaccinia can be adapted for the development of live recombinant vaccines. This review discusses recombinant vaccinia design and the feasibility of using these vaccines for disease protection.

From an epidemiological perspective, the practice of universal vaccination of girls and young women in order to prevent human papilloma virus (HPV) infection and potential development of cervical cancer is widely accepted even though it may lead to the neglect of other preventive strategies against cervical cancer.

The article analyses the public policy of vaccination against the human papilloma virus according to the three classical criteria of need, efficacy and safety as an exemplary case of how the big transnational corporations operate and how the governments serve their interests. It discusses the changes in policy in Japan and the recent developments in France and the grass-roots movements in Spain that are organizing to change this policy. The four Lacanian discourses are applied to the analysis of the rhetoric (...) of public health authorities. (shrink)

Development of a vaccine for schistosomiasis, a parasitic disease currently affecting over 200 million people worldwide, has been targeted as a priority by the World Health Organisation. Research demonstrating the ability of humans to acquire natural immunity to schistosome infection, together with the successful use of attenuated vaccines in animals both under laboratory and field conditions, suggest that development of a human vaccine is feasible. Attenuated vaccines for schistosomiasis are considered neither safe nor practicable for human (...) use, however, and therefore other approaches must be considered. This review examines progress currently being undertaken in a number of different areas towards achieving the goal of a safe and effective human vaccine for schistosomiasis. (shrink)

In the development of new vaccines, many trials use age de-escalation: after establishing safety and efficacy in adult populations, progressively younger cohorts are enrolled and studied. Age de-escalation promotes many values. The responsibility to protect children from potential risks of experimental vaccines is significant, not only given increased risks of adverse effects but also because parents and medical professionals have a moral responsibility to protect children from harms associated with novel, uncertain interventions. Further, given that young children cannot provide (...) informed consent, acceptable risks for research requiring proxy consent are lower than for adults making decisions for themselves. Although age de-escalation approaches are widely used in vaccine trials, including notably in the recent development of pediatric COVID-19 vaccines, ethicists have not addressed the benefits and risks of these approaches. Their benefits are largely assumed and unstated, while their potential risks are usually overlooked. There are no official ethics guidelines for the use of age de-escalation in clinical research. In this paper, we provide a systematic account of key moral factors to consider when employing age de-escalation. Analyzing pediatric COVID-19 vaccine development as our key case study, we clarify the benefits, risks, and trade-offs involved in age de-escalation approaches and call for the development of evidence-based best practice guidelines to identify when age de-escalation is likely to be an ethical strategy in vaccine development. (shrink)

Abstractabstract:Vaccine hesitancy continues to pose a formidable obstacle to increasing national COVID-19 vaccination rates in the US, but this is not the first time that American vaccination efforts have confronted resistance and apathy. This study examines the history of US vaccination efforts against smallpox, polio, and measles, highlighting persistent drivers of vaccine hesitancy as well as factors that helped overcome it. The research reveals that logistical barriers, negative portrayals in the media, and fears about safety stymied inoculation (...) efforts as early as the 18th century and continue to do so. However, vaccine hesitancy has been markedly diminished when trusted community leaders have guided efforts, when ordinary citizens have felt personally invested in the success of the vaccine, and when vaccination efforts have been tied to broader projects to improve public health and social cohesion. Deliberately cultivating such factors could be an effective strategy for lessening opposition today, when COVID-19's distinctive characteristics make addressing vaccine hesitancy more urgent than it has ever been. (shrink)

Human papillomavirus (HPV) is one of the most common sexually transmitted infections. It is a leading cause of cervical cancer in women but the virus is increasingly being linked to several other cancers in men and women alike. Since the introduction of safe and effective but also expensive vaccines, many developed countries have implemented selective vaccination programs for girls. Some however argue that these programs should be expanded to include boys, since (1) HPV constitutes non-negligible health risks for boys as (...) well and (2) protected boys will indirectly also protect girls. In this paper we approach this discussion from an ethical perspective. First, on which moral grounds can one justify not reimbursing vaccination for the male sex? We develop an ethical framework to evaluate selective vaccination programs and conclude that, in the case of HPV, efficiency needs to be balanced against non-stigmatization, non-discrimination and justice. Second, if vaccination programs were to be expanded to boys as well, do the latter then also have a moral duty to become immunized? Two arguments in favor of such a moral duty are well known in vaccination ethics: the duty not to harm others and to contribute to the public good of public health. However, we argue that these are not particularly convincing in the context of HPV. In contrast, we believe a third, more powerful but also more controversial argument is possible. In our view, the sexual mode of transmission of HPV constitutes an additional reason to believe that boys in fact may have a moral obligation to accept vaccination. (shrink)

Bovine tuberculosis is a controversial animal health policy issue in England, which impacts farmers, the public, cattle and badgers. Badgers act as a wildlife reservoir of disease. Policy options for badger control include do nothing, badger culling, and badger vaccination. This paper argues for mandatory Animal Welfare Impact Assessment for all policy that significantly affects sentient animals. AWIA includes species description, and AWIA analysis stages. In this paper, AWIA is applied to impacts of bovine TB policy options on cattle and (...) badgers. Over 4 years, 85,000 badgers will be culled to prevent the slaughter of ~17,750 cattle over 9 years. Hence, about five badgers are culled for every cow which avoids slaughter. The AWIA analyses the impact of badger vaccination on cows and badgers based on a set of stated assumptions. The AWIA estimates badger vaccination to reduce the number of cows slaughtered by 11,600, i.e. a 12.5% reduction. Additional to the harm of killing, culling has greater welfare impacts on badgers compared to non-culling options. Actors in animal health and welfare policy were interviewed about the concept of AWIA. Policy actors supported the idea of AWIA to provide objective data to feed into policy making. The paper concludes with the proposal that AWIA is a necessary stage of just policy making where sentient animals are impacted by government policy. (shrink)

This paper examines the case of Ebola, ça Suffit trial which was conducted in Guinea during Ebola Virus Disease (EVD) outbreak in 2015. I demonstrate that various non-epistemic considerations may legitimately influence the criteria for evaluating the efficacy and effectiveness of a candidate vaccine. Such non-epistemic considerations, which are social, ethical, and pragmatic, can be better placed and addressed in scientific research by appealing to non-epistemic values. I consider two significant features any newly developed vaccine should possess; (1) (...) the duration of immunity the vaccine provides; and (2) safety with respect to the side effects of the vaccine. Then, I argue that social and ethical values are relevant and desirable in setting the parameters for evaluating these two features of vaccines. The parameters that are employed for setting up the criteria for assessing the features might have far-reaching implications on the well-being of society in general, and the health conditions of several thousand people in particular. The reason is that these features can play a decisive role during the evaluation of the efficacy and effectiveness of the vaccine. I conclude by showing why it is necessary to reject the concept of epistemic priority, at least when scientists engage in policy-oriented research. (shrink)

BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of (...) consent.Cross-sectional study conducted over a 4 month period.MethodsConsent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured.ResultsThe majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%–77% and for understanding 75% (IQR = 50%–87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 – 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35–5.07) to obtain such scores for recall than those who were not.ConclusionNotwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent. (shrink)

Background The world has come closer than ever to discovering a viable HIV vaccine. However, it remains less certain whether HIV vaccines should be made available to participants and communities in which trials are run no or subsidized cost. Hence the essence of this inquiry.Methodology This is a case study design using in-depth interviews (IDI) and focus group discussions (FGD) with researchers of HIV vaccine trials, institutional review board (IRB) members, HIV advocates, a policy maker, and members of (...) community advisory board (CAB) in Tanzania. Participants were purposively selected and data thematically analyzed using MAXQDA software.Results Hosting a vaccine trial and the financial incapacity of individuals at increased risk of HIV were among the reasons in favor of free access to HIV vaccines. In contrast, the view that vaccines should be provided at a subsidized cost was related to high costs of vaccine development, financial return expectations by investors, and the fear of labeling the free vaccine as less important. Moreover, apart from governments and international organizations, well-off individuals could share the cost burden.Conclusion Stakeholders engaging in active discussion about sharing the viable vaccine ought to take the aforementioned concerns into account and ensure unhindered access to individuals and host communities in Tanzania and beyond. (shrink)

BackgroundVaccination has been considered one of the most effective public health interventions. In the context of the global epidemic of coronavirus disease 2019, it remains unclear what role general vaccination attitudes and perceptions have on the acceptance of COVID-19 vaccine.ObjectiveThis study aims to explore the impact of general attitudes and perceptions toward vaccination on the acceptance of a newly developed vaccine, taking COVID-19 vaccines as an example.MethodA cross-sectional survey was conducted among 2,013 Chinese adult participants. Generalized order logistic (...) regression and path analysis models were used to analyze impacts of general attitudes and perceptions toward vaccination on the acceptance of the COVID-19 vaccine.ResultsThe prevalence of hesitancy to vaccination in general is 49.9% among the Chinese adult population. General perceptions of vaccination were associated with corresponding perceptions of the COVID-19 vaccine. A “no hesitancy” attitude toward vaccination is a significant determinant of future COVID-19 vaccination compared to vaccine refusers, and perceptions of COVID-19 vaccine remain a significant determinant for the acceptance of the COVID-19 vaccine. Path analysis indicates that perceptions of the importance and safety of vaccination have a positive overall effect on the acceptance of the COVID-19 vaccine, and that general perceptions of vaccination as a whole on each measure indirectly influence the acceptance of the COVID-19 vaccine.ConclusionGeneral attitudes and perceptions toward vaccination were associated with those of the COVID-19 vaccine and future vaccination intention. To prepare for possible emergence of diseases in the future, routine health campaigns should be launched by relevant government departments and vaccination authorities to enhance the overall awareness and knowledge of vaccination among the public and to ensure optimal vaccination experience. In addition, targeted knowledge dissemination and mass mobilizations should be urged for newly developed vaccines when some specific infectious diseases emerge, such as COVID-19 at present. (shrink)

Background. To inform their health decisions, patients may seek narratives describing other patients' evaluations of their treatment experiences. Narratives can provide anti-treatment or pro-treatment evaluative meaning that low-numerate patients may especially struggle to derive from statistical information. Here, we examined whether anti-vaccine narratives had relatively stronger effects on the perceived informativeness and judged vaccination probabilities reported among recipients with lower numeracy. Methods. Participants from a nationally representative US internet panel were randomly assigned to an anti-vaccine or pro-vaccine (...) narrative, as presented by a patient discussing a personal experience, a physician discussing a patient's experience, or a physician discussing the experiences of 50 patients. Anti-vaccine narratives described flu experiences of patients who got the flu after getting vaccinated; pro-vaccine narratives described flu experiences of patients who got the flu after not getting vaccinated. Participants indicated their probability of getting vaccinated and rated the informativeness of the narratives. Results. Participants with lower numeracy generally perceived narratives as more informative. By comparison, participants with higher numeracy rated especially anti-vaccine narratives as less informative. Anti-vaccine narratives reduced the judged vaccination probabilities as compared with pro-vaccine narratives, especially among participants with lower numeracy. Mediation analyses suggested that low-numerate individuals' vaccination probabilities were reduced by anti-vaccine narratives - and, to a lesser extent, boosted by pro-vaccine narratives - because they perceived narratives to be more informative. These findings were similar for narratives provided by patients and physicians. Conclusions. Patients with lower numeracy may rely more on narrative information when making their decisions. These findings have implications for the development of health communications and decision AIDS. (shrink)

After the louse transmission of epidemic typhus had been established (1909), a small microorganism (thought to belong to a new genus, Rickettsia) was shown in enormous numbers in the guts of lice that had fed on human typhus victims. Attempts at cultivating this organism on inert media failed; tansfer from louse to louse without loss of virulence for the vertebrate host was successful. Some scientists were not convinced of the etiologic role of Rickettsiae, because the presence of this microbe in (...) blood and organs of victims or of experimentally infected animals was difficult to demonstrate. This uncertainty was dispelled in 1928, when in guinea pigs infected with material from the closely related disease Tabardillo (murine typhus) abundant Rickettsiae were revealed in the tunica vaginalis. Live vaccines, derived from strains of murine typhus and deployed in French North Africa, were considered by outside observers as unsafe. Killed vaccines were derived from the masses of Rickettsiae present in louse guts, in chick embryo yolk sacs or in vertebrate lungs. These developments were not spurned by any 'upswing of virology' but by the threat of typhus in endemic areas and, after 1938, in a war-torn world. Their basis was firmly anchored in bacteriological thought styles and techniques. (shrink)

ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to be (...) white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently , and were less likely to think that HVT participants understood risks and benefits or informed consent forms . In both countries, members were divided on several critical issues , but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences , along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere. (shrink)

The rapid spread of SARS‐CoV‐2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID‐19 vaccines in less than 1 year while raising sustained scrutiny as to the ethical issues associated with this process. This article pursues a twofold objective. First, it reconstructs and provides a thorough overview of the different steps, from clinical trial design to regulatory procedures, underpinning the “fast‐tracking” of COVID‐19 vaccine R&D and approval. Second, (...) drawing on a review of published literature, the article identifies, outlines, and analyzes the most ethically challenging aspects related to such process, including concerns around vaccine safety, issues in study design, the enrollment of study participants, and the challenges in obtaining valid informed consent. By scrutinizing relevant aspects of COVID‐19 vaccine development and regulatory processes leading to market authorization, this article ultimately aims to provide a comprehensive overview of the regulatory and ethical issues underpinning the roll‐out of this key pandemic‐containment technology worldwide. (shrink)

Cuba faces a dilemma between continuing its current portfolio of biotechnology drugs and vaccines with lower profitability or renewing its product portfolio with the associated costs and risks.

This article highlights and evaluates the role of CEPI and its contribution to global equitable access to COVID-19 vaccines through its established partnerships for vaccine development. The article adds to the understanding of how and when such partnerships can work for public health, especially under emergency citations.

Currently, millions of minors are being inoculated against SARS-CoV-2 in many countries in the world. Ethical concerns about clinical research involving children have barely been addressed in the literature, despite the fact that the paediatric population is particularly vulnerable within this context. Children should be included in the research plans for COVID-19 vaccines. Nevertheless, it is necessary to critically assess to what extent clinical trials are being conducted according to methodological and ethical criteria that allow us to conclude that the (...) results are valid and, in consequence, how far the vaccination plans for children are scientifically justified.The principal aim of this article is to analyse critically the process of clinical research on COVID-19 vaccines involving children, highlighting the ethical concerns that arise, including the need to stratify the results from older adolescents separately for analysis before proceeding, if further research is warranted, in descending age order. The development of COVID-19 vaccines is examined, with a special look at the participation of children throughout their clinical development, including a review of the clinical trials registered in three international databases. We also offer some additional considerations about the inclusion of minors in vaccination plans. Finally, we conclude with some recommendations, with particular emphasis on the following ethical duties: research in children should be carried out only once the relevant research in adults has previously been conducted; issues that concern children’s needs and rights should be specifically addressed; and, therefore, the highest standards of ethical and scientific quality should be met. (shrink)

The development of some COVID-19 vaccines by private companies like Moderna and Sanofi-GSK has been substantially funded by various governments. While the Sanofi CEO has previously suggested that countries that fund this development ought to be given some priority, this suggestion has not been taken seriously in the literature. Considerations of nationalism, sustainability, need, and equitability have been more extensively discussed with respect to whether and how much a country is entitled to advance purchase orders of the (...) class='Hi'>vaccine under conditions of absolute scarcity. Yet, little attention has been paid to whether prior investment into developing a vaccine entitles a country to some priority with respect to these orders. Moreover, while not a majority view, some survey results show that a significant minority of the populace does endorse some view like this. This article argues that the minority have a point: recognizing funder countries some priority is justified by the weak Lockean claim (WLC). According to the WLC, the fact that someone has contributed to the development of something gives them some entitlement to the resultant product. This article will defend the WLC, and address objections to the argument, including those pertaining to questions of historical injustice and medical need. This argument does not imply an unconstrained entitlement. Rather, contribution to development is one morally relevant factor that must be tempered by and weighed against potentially more substantial claims to priority based on need, equity, and other considerations. (shrink)

The rapid development of vaccines against COVID‐19 represents a huge achievement, and offers hope of ending the global pandemic. At least three COVID‐19 vaccines have been approved or are about to be approved for distribution in many countries. However, with very limited initial availability, only a minority of the population will be able to receive vaccines this winter. Urgent decisions will have to be made about who should receive priority for access. Current policy in the UK appears to take (...) the view that those who are most vulnerable to COVID‐19 should get the vaccine first. While this is intuitively attractive, we argue that there are other possible values and criteria that need to be considered. These include both intrinsic and instrumental values. The former are numbers of lives saved, years of life saved, quality of the lives saved, quality‐adjusted life‐years (QALYs), and possibly others including age. Instrumental values include protecting healthcare systems and other broader societal interests, which might require prioritizing key worker status and having dependants. The challenge from an ethical point of view is to strike the right balance among these values. It also depends on effectiveness of different vaccines on different population groups and on modelling around cost‐effectiveness of different strategies. It is a mistake to simply assume that prioritizing the most vulnerable is the best strategy. Although that could end up being the best approach, whether it is or not requires careful ethical and empirical analysis. (shrink)

Conflicts of interest are common and exist in academia, government, and many industries, including pharmaceutical development. Medical journal editors and others have recently criticized “the pharmaceutical industry,” citing concerns over investigator access to data, approaches to analysis of clinical trial data, and publication practices. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures, and markets a broad range of human and animal health products, directly and through its joint ventures. Although part of its mission (...) is to provide a superior rate of return to its investors, Merck does not believe this creates an irreconcilable conflict of interest, particularly in activities concerning clinical drug development. We employ rigorous scientific methods to design, conduct, analyze, and report results of clinical trials in the development of innovative drugs and vaccines, with a focus on meeting unmet medical needs and with an ethic that puts the interests of the patient first. This article describes Merck’s approaches to potential conflicts of interest in drug development, particularly with regard to clinical trials. We believe that proprietary interests of the Company can be respected while observing objectivity and transparency in communicating clinical research results. The standards for the review of manuscripts reporting such trials for peer-reviewed publication should be the same, whether they are from Merck or elsewhere. (shrink)

This article explores the role scientists at the National Cancer Institute, a US federal science agency, played in researching and testing vaccines against the human papillomavirus. Drawing upon archival sources and oral history interview data, I challenge narratives that attribute the design of HPV vaccines to profit motive. Instead, I show that the researchers who developed the technology attempted to construct ethical approaches to vaccine development based on the values that emerged from their situated environments of technological, organizational, (...) and institutional constraint. I argue that interpretations of “translational research” native to the NCI influenced these researchers’ efforts to design and test HPV vaccines. The organizational culture of translational research emerging in the NCI positioned intramural research as a countervailing and supplementary force to market-oriented translational research and development. Over time, NCI researchers’ conceptions of the Institute’s role allowed them to develop understandings of ethical HPV vaccine research as oriented toward addressing cervical cancer health disparities, especially in developing nations. NCI scientists’ understanding of their role in serving the public good through continued HPV vaccine innovation reflects the material and political economic environment they faced at different historical junctures that constrained the possibilities for innovation and ethical action. (shrink)

McGovern, Kevin; Brussen, Kerri Anne Some vaccines are produced using cell lines which were originally developed from tissue from an aborted foetus. Vaccines are ethically compromised by this connection to abortion. within the Catholic Church, the Pontifical Academy for Life has called for research and development of alternative vaccines which are ethically acceptable. Until alternative vaccines are developed, it has also accepted the use even of these ethically compromised vaccines in order to protect children, pregnant women and the population (...) as a whole from the risk of contracting serious disease. This article explores all these issues from an Australian perspective. (shrink)

The fact that Internet companies may record our personal data and track our online behavior for commercial or political purpose has emphasized aspects related to online privacy. This has also led to the development of search engines that promise no tracking and privacy. Search engines also have a major role in spreading low-quality health information such as that of anti-vaccine websites. This study investigates the relationship between search engines’ approach to privacy and the scientific quality of the information (...) they return. We analyzed the first 30 webpages returned searching “vaccines autism” in English, Spanish, Italian, and French. The results show that not only “alternative” search engines but also other commercial engines often return more anti-vaccine pages (10–53%) than Google (0%). Some localized versions of Google, however, returned more anti-vaccine webpages (up to 10%) than Google. Health information returned by search engines has an impact on public health and, specifically, in the acceptance of vaccines. The issue of information quality when seeking information for making health-related decisions also impact the ethical aspect represented by the right to an informed consent. Our study suggests that designing a search engine that is privacy savvy and avoids issues with filter bubbles that can result from user-tracking is necessary but insufficient; instead, mechanisms should be developed to test search engines from the perspective of information quality (particularly for health-related webpages) before they can be deemed trustworthy providers of public health information. (shrink)

Human papillomavirus (HPV) infection is the world’s most common sexually transmitted infection. It is a prerequisite for cervical cancer, the second most common cause of death in cancer among women worldwide, and is also believed to cause other anogenital and head and neck cancers. Vaccines that protect against the most common cancer-causing HPV types have recently become available, and different countries have taken different approaches to implementing vaccination. This paper examines the ethics of alternative HPV vaccination strategies. It devotes particular (...) attention to the major arguments for and against one strategy: voluntary, publicly funded vaccination for all adolescent boys and girls. This approach seems attractive because it would protect more people against cervical cancer and other HPV-related cancers than less inclusive alternatives, without the sacrifice of autonomy that a comparably broad compulsory programme would require. Also, the herd immunity that it would likely generate would protect those who remain unvaccinated, a major advantage from a justice perspective. However, there is a possibility that a HPV vaccination programme targeting all adolescents of both sexes is not considered sufficiently cost-effective. Also, it might pose more difficulties for achieving informed consent than comparable vaccination programmes against other diseases. Ultimately, society’s choice of HPV vaccination strategy requires careful consideration not only of the values at stake but also of available and emerging scientific evidence. (shrink)

Seven COVID-19 vaccines are now being distributed and administered around the world (figure correct at the time of submission), with more on the horizon. It is widely accepted that healthcare workers should have high priority. However, questions have been raised about what we ought to do if members of priority groups refuse vaccination. Using the case of influenza vaccination as a comparison, we know that coercive approaches to vaccination uptake effectively increase vaccination rates among healthcare workers and reduce patient morbidity (...) if properly implemented. Using the principle of least restrictive alternative, we have developed an intervention ladder for COVID-19 vaccination policies among healthcare workers. We argue that healthcare workers refusing vaccination without a medical reason should be temporarily redeployed and, if their refusal persists after the redeployment period, eventually suspended, in order to reduce the risk to their colleagues and patients. This ‘conditional’ policy is a compromise between entirely voluntary or entirely mandatory policies for healthcare workers, and is consistent with healthcare workers’ established professional, legal and ethical obligations to their patients and to society at large. (shrink)

This dissertation explores the ethics of human subjects research with particular attention to how clinical research on vaccines differs from research on therapies. The major differences are rooted in the fact that the benefits of vaccines and vaccine research accrue to the community to which vaccines belong by inducing herd immunity and thereby protecting both vaccinated and unvaccinated individuals. Therapeutics have no corresponding benefit to the community, the primary beneficiary is the individual. The ethical justification for conducting vaccine (...) research in a given community therefore should include an evaluation of the risks and benefits to the community as well as to involved individuals. Respect for individuals extends to respect for communities and for individuals as members of communities. A three way partnership between investigators, the community, and the community members is suggested as an ethical foundation for vaccine research. ;This model is then applied to the particular and complex case of testing a preventive HIV vaccine. HIV is an unique virus which continues to cause extraordinary devastation worldwide. The characteristics of HIV, its transmission and epidemiology, along with unprecedented scientific possibilities present a formidable challenge to the development and testing of an HIV vaccine. Using the community model, specific suggestions are made for the ethical conduct of clinical efficacy trials of HIV preventive vaccines. (shrink)

Addressing vaccination hesitancy is a major challenge in the fight against infectious disease. Vaccine hesitancy has given rise to recent outbreaks of vaccine preventable diseases (e.g., measles) in developed countries. In developed regions, particularly Europe and North America non-structural barriers to vaccination such as risk perceptions and philosophical beliefs seem to play a crucial role in vaccination uptake (Larson et al. 2014), and also contribute to current vaccine hesitancy with regard to COVID-19. To combat these developments, understanding (...) psychological factors in vaccination hesitancy is increasingly important. A better understanding of these psychological factors in turn points to communication strategies that can reduce vaccine hesitancy. These strategies depend upon individuals’ possession of capacities that are required for morally responsible agency (“responsibility-level capacities”), and in particular the capacities to recognize and respond to reasons. Strategic communication concerning vaccines can improve the exercise of individuals’ responsibility-level capacities as they pertain to risk perception and outcome expectancies. We begin by introducing cutting-edge work from the philosophical literature on agency and responsibility, with a special focus on the responsibility-level capacities at work in the practical context of deciding whether to vaccinate. We then summarize lessons drawn from a variety of studies in psychology and behavioural economics on how individuals reason, decide, and behave in these practical contexts. These lessons help illuminate the extent to which individuals exercise responsibility-level capacities in such contexts while also pointing to strategies that can improve the exercise of those capacities. (shrink)

We discuss whether and under what conditions people should be allowed to choose which COVID-19 vaccine to receive on the basis of personal ethical views. The problem arises primarily with regard to some religious groups’ concerns about the connection between certain COVID-19 vaccines and abortion. Vaccines currently approved in Western countries make use of foetal cell lines obtained from aborted foetuses either at the testing stage or at the development stage. The Catholic Church’s position is that, if there (...) are alternatives, Catholic people have a moral obligation to request the vaccine whose link with abortion is more remote, which at present means that they should refuse the Oxford/AstraZeneca vaccine. We argue that any consideration regarding free choice of the vaccine should apply to religious and non-religious claims alike, in order to avoid religion-based discrimination. However, we also argue that, in a context of limited availability, considering the significant differences in costs and effectiveness profile of the vaccines available, people should only be allowed to choose the preferred vaccine if: 1) this does not risk compromising vaccination strategies; and 2) they internalize any additional cost that their choice might entail. The State should only subsidize the vaccine that is more cost-effective for any demographic group from the point of view of public health strategies. (shrink)