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Background: Analysing the Canadian government’s efforts to support the development of COVID-19 "medical countermeasures" (MCMs), this article seeks insights into political economy as a driver of pandemic response. We explore whether Canadian public funding policy during the pandemic involved departures from established practices of financialisation in biopharmaceutical research and development, including the dominance of private sector involvement in an IP intensive approach to innovation underscoring profit, and governance opacity. Methods: We interrogate public funding for MCMs by analyzing how much the Government of Canada (GoC) spent, how those funds were allocated, on what terms, and to whom. We identify the funding institutions, and the funds awarded between February 10, 2020, and March 31, 2021, that were allocated to support the research, development, and manufacturing of MCMs, including diagnostics, vaccines, therapeutics, and information about clinical management and virus transmission. To collect these data, we conducted searches on the Internet, public data repositories, and filed several requests under the Access to Information Act (1985) Subsequently, we carried out a document-based analysis of electronically accessible research contracts, proposals, grant calls, and policy announcements. Results: Between February 10, 2020 and March 31, 2021, the GoC announced CAD $1.4 billion for research, development and manufacturing of COVID-19 MCMs. Fully 68% (CAD $ 959 million) of the announced public funding was channelled to investment in private sector firms. Canadian public funding showed a consistent focus on early and late stage development of COVID-19 MCMs and the expansion of biopharmaceutical manufacturing capacity. Assessing whether Canada’s investments in to developing COVID-19 MCMs safeguard affordable and transparent access to the products of publicly funded research, we found that access policies on intellectual property management, sharing of clinical data, affordability and availability were not systematic, consistent, or transparent, and few, if any, mechanisms ensured long-term sustainability. Conclusion: Beyond incremental change in policy goals, such as public investment in domestic biomanufacturing, the features of Canadian public policies endorsing financialization in the biopharmaceutical sector remained largely unchanged during the pandemic.

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, however, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada's COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID-19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amendments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement.

L’Organisation mondiale de la Santé (OMS) reconnaît que la vaccination est l’une des interventions en matière de santé publique les plus efficaces pour sauver des vies. Lors de l’élaboration d’une feuille de route permettant d’établir un ordre de priorité relatif à l’utilisation des vaccins contre la maladie à coronavirus 2019 (COVID-19) dans un contexte d’approvisionnement limité, l’OMS a souligné l’importance d’un cadre de valeurs (principes éthiques). La vaccination doit faire l’objet d’un examen éthique indépendant des données de recherche sur les vaccins, des pratiques de fabrication, de l’assurance juridique et éthique du consentement éclairé, ainsi que des questions de justice sociale concernant l’équité des programmes, y compris le droit d’accès. Un examen déontologique du programme de vaccination de l’Australie a été rapporté en 2012. Ce dossier CANVax (Centre canadien de ressources et d’échange sur les données probantes en vaccination) propose un examen déontologique de la vaccination au Canada en utilisant les critères utilisés pour l’Australie.

Background Little is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate. Methods Observation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants’ stories to develop two ideal portraits based on "composite characters" based on study participants features. These provide ethnographically rich details of participants’ meaningful social worlds while protecting individual identities. Results Ten of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation. Conclusions Our findings support Fisher’s argument of “structural coercion” in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie “under consent” of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North.

UNSTRUCTURED The COVID-19 pandemic has spotlighted the intertwining of politics and public health. So too, a public health tool, surveillance, can also be used to expose the political context of an event and to guide better public health interventions. In its current form, infoveillance tends to neglect identity and interest-based users. Adopting an algorithmic tool to appropriately classify short social media texts might remedy that gap. Our study advances a computational framework to cluster Twitter users based on their identities and interests as expressed through Twitter bio pages. The framework then uses BERT topic modeling to identify topics by the user clusters. By analyzing the Twitter discourse on masks and mask-wearing during COVID-19 in the English-speaking world, we show how online discourse shifted over time and varied by four user clusters: Conservative political, Progressive political, General Public, and Public Health Professionals. The political groups and general public focused on the science of mask-wearing and the partisan politics of mask policies. A populist discourse that pits citizens against elites and institutions was identified in some tweets. Politicians (such as Donald Trump) and geopolitical tensions (with regards to China) were found to drive the discourse. Our data show limited participation of public health professionals compared to other users. We conclude by discussing the importance of a priori user classification in analyzing online discourse and illustrating the fit of BERT topic modeling in identifying contextualized topics in short social media texts.

In Canada, vaccination that protects against pertussis and influenza is recommended in every pregnancy, but uptake remains low. Communicating the risks and benefits of vaccination is key to clinical conversations about vaccination, which may influence the uptake of pregnancy and subsequent infant vaccines. Canadian midwives use an informed choice model of care, which is distinct from informed consent and prioritizes client autonomy in decision-making.Using institutional ethnography, which treats lived experience as expertise, we aimed to understand how Canadian midwives, governed by intersecting professional standards and regulations, navigate vaccine discussions with their clients. We conducted interviews with individuals involved in midwifery training, regulation, and continuing education, as well as key public health professionals with expertise in immunization training. Following the phases of thematic analysis outlined by Braun and Clarke, data were analyzed holistically, emergent themes identified, and coding categories developed.Two types of confidence emerged as important to midwives' ability to conduct a thoroughly informed choice discussion about vaccines: confidence in vaccination itself (vaccine confidence), and confidence in vaccine knowledge and counseling skills (vaccine counseling confidence). A deferred or shortened vaccine discussion could be the result of either vaccine hesitancy or counseling hesitancy.Currently, available clinical communication tools and recommended techniques for addressing vaccine hesitancy do not always adapt well to the needs of midwives working to support clients' informed choice decisions. Our findings suggest that Canadian midwives require more and clearer resources on both the risks and benefits of vaccination in pregnancy.

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used. ispartof: INTERNATIONAL JOURNAL OF HEALTH SERVICES vol:51 issue:1 pages:5-13 ispartof: location:United States status: published

International trends currently favour greater use of mandatory immunization. There has been little academic consideration or comparison of the existence and scope of mandatory immunization internationally. In this paper, we examine mandatory immunization in 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, including countries from every WHO region and World Bank income level classification. We found that although mandatory immunization programs, or mandatory elements within broader immunization programs, are relatively common, jurisdictions vary significantly with respect to the immunizations required, population groups affected, grounds for exemptions, and penalties for non-compliance. We also observed some loose associations with geography and income level. Based on these data, we categorized policies into a spectrum ranging from Narrow to Broad scope.

Communication is central to the implementation and effectiveness of public health measures. Informed by theories of good governance, COVID-19 pandemic public health messaging in 3 Canadian provinces is assessed for its potential to encourage or undermine public trust and adherence.This study employed a mixed-methods constant comparative approach to triangulate epidemiological COVID-19 data and qualitative data from news releases, press briefings, and key informant interviews. Communications were analyzed from January 2020 to October 2021 in Nova Scotia, Ontario, and Alberta. Interview data came from 34 semi-structured key informant interviews with public health actors across Canada. Team-based coding and thematic analysis were conducted to analyze communications and interview transcripts.Four main themes emerged as integral to good communication: transparency, promptness, clarity, and engagement of diverse communities. Our data indicate that a lack of transparency surrounding evidence and public health decision-making, delays in public health communications, unclear and inconsistent terminology and activities within and across jurisdictions, and communications that did not consider or engage diverse communities' perspectives may have decreased the effectiveness of public health communications and adherence to public health measures throughout the COVID-19 pandemic.This study suggests that increased federal guidance with wider jurisdictional collaboration backed by transparent evidence could improve the effectiveness of communication practices by instilling public trust and adherence with public health measures. Effective communication should be transparent, supported by reliable evidence, prompt, clear, consistent, and sensitive to diverse values. Improved communication training, established engagement infrastructure, and increased collaborations and diversity of decision-makers and communicators are recommended.RéSUMé: OBJECTIFS: La communication est centrale à l’implantation et au succès des mesures de santé publique. À partir des théories de bonne gouvernance, les messages de santé publique sur la COVID-19 de trois provinces canadiennes ont été analysés afin d’évaluer si ces messages renforçaient ou diminuaient la confiance et l’adhésion de la population. MéTHODES: Cette étude utilise une approche comparative constante et des méthodes mixtes pour trianguler des données épidémiologiques sur la COVID-19 avec des données qualitatives provenant de communiqués de presse, de conférences de presse et d’entretiens avec des informateurs clés. Les communications ont été analysées entre janvier 2020 et octobre 2021 en Nouvelle-Écosse, Ontario et Alberta. Les données proviennent également de 34 entretiens semi-dirigés avec des acteurs de santé publique à travers le Canada. Une codification en équipe et une analyse de contenu thématique ont été réalisées pour analyser les communications et les verbatim des entretiens. RéSULTATS: Quatre thèmes principaux sont apparus comme faisant partie intégrante d’une bonne communication : la transparence, la rapidité, la clarté et l’engagement des diverses communautés. Nos données indiquent qu’un manque de transparence en ce qui a trait aux données probantes et aux processus de prise de décision en santé publique, que les retards dans les stratégies de communication de santé publique, qu’une terminologie et des activités incohérentes et inconsistantes dans les provinces et entre elles, ainsi que des communications qui ne tenaient pas compte des points de vue ou qui n’incluaient pas les diverses communautés, ont pu réduire l’efficacité des communications et l’adhésion aux mesures de santé publique tout au long de la pandémie de COVID-19. CONCLUSION: Cette étude suggère que des lignes directrices nationales et une collaboration accrue entre les provinces et les territoires soutenues par des données probantes transparentes pourraient améliorer l’efficacité des communications en suscitant la confiance du public et l’adhésion aux mesures de santé publique. Une communication efficace doit être transparente, appuyée sur des données probantes fiables, rapide, claire, cohérente et sensible aux différentes valeurs. Il est recommandé d’améliorer la formation en communication, d’établir une infrastructure pour accroître l’engagement, et de soutenir la collaboration et la diversité des décideurs et des communicateurs.

To explore Nova Scotian experiences, barriers, and facilitators associated with pandemic public health measures (PHM), including COVID-19 vaccination.We conducted semi-structured, individual interviews with Nova Scotians between May and August 2021, during the third wave of COVID-19 cases and provincial lockdown. Participants were recruited across the province from three sectors: decision makers, community leaders, and community members using purposive and snowball sampling. Direct content analysis and thematic analysis were used to identify key themes via the Theoretical Domains Framework.The experiences of 30 Nova Scotian interviewees clustered around four themes: Communication of PHM, Responsibly Observing PHM: A Community Coming Together, Navigating PHM, and Vaccine ConfidenceHesitancy. Consistent communication of PHM through briefings with the chief medical officer of health and provincial channels reduced misinformation and encouraged PHM compliance. While adherence was high throughout the province, inconsistent enforcement of these measures proved challenging to individuals navigating PHMs. A high level of COVID-19 vaccine confidence and acceptance was identified, and a strong sense of provincial pride prevailed in keeping COVID-19 numbers and transmission low.This study provides insights into Nova Scotians' unique experiences with COVID-19 PHM. Provincial public health experts and government leaders communicated PHM with various levels of success, Nova Scotia Strong, a sentiment of unity and communitarianism that sprang from public response to tragic events. Future work should aim to include under-represented communities to facilitate broader inclusion.RéSUMé: OBJECTIF: Explorer les expériences des Néo-Écossais et les éléments qui entravent ou qui favorisent les mesures sanitaires pandémiques (MSP), dont la vaccination contre la COVID-19, en Nouvelle-Écosse. MéTHODE: Nous avons mené des entretiens individuels semi-directifs avec des Néo-Écossais entre mai et août 2021, au cours de la troisième vague de cas de COVID-19 et de confinement dans la province. Des participants de trois groupes (décideurs, responsables locaux et résidents) ont été recrutés dans toute la province à l’aide de sondages intentionnels et cumulatifs. Nous avons utilisé l’analyse directe de contenu et l’analyse thématique pour cerner les principaux thèmes à l’aide du cadre des domaines théoriques (cadre TDF). RéSULTATS: Les expériences des 30 Néo-Écossais interrogés s’articulaient autour de quatre thèmes : Communication des MSP, Observance responsable des MSP : une communauté qui se rassemble, S’y retrouver dans le dédale des MSP et Confiance envers les vaccins et hésitation vaccinale. La communication cohérente des MSP lors des breffages du médecin-hygiéniste en chef et par les canaux provinciaux a réduit la mésinformation et encouragé l’observance des MSP. Cette observance était élevée à l’échelle de la province, mais l’application incohérente des mesures a rendu difficile pour les gens de s’y retrouver dans le dédale des MSP. Un niveau élevé de confiance et d’acceptation des vaccins contre la COVID-19 a été observé, et un profond sentiment de fierté provinciale a pris le dessus pour réduire le nombre de cas et la transmission de la COVID-19. CONCLUSION: Cette étude vient éclairer les expériences uniques des Néo-Écossais face aux MSP liées à la COVID-19. Les spécialistes provinciaux de la santé publique et les chefs du gouvernement ont communiqué les MSP de façon coordonnée et ont bénéficié du sentiment d’unité et de l’esprit communautaire (Nova Scotia Strong) qui ont émergé dans la population à la suite d’autres tragédies. Les démarches futures devraient chercher à inclure les communautés sous-représentées.

The COVID-19 pandemic represents not only the spread of a highly contagious and potentially fatal virus, but also an outbreak of theories, rumors, discourses and representations trying to make sense of a crisis. In this article, we explore the issue of blame and stigma in the context of the COVID-19 pandemic in Canada. We do so by studying editorial cartoons published about COVID-19 in ten mainstream Canadian newspapers between January 2020 and March 2021. We identified 203 editorial cartoons that highlight common discourses which blame or stigmatize specific groups of people for the origin or transmission of COVID-19, or for their behavior during the pandemic. The cartoons focused on four groups: 1) people of Chinese origin or descent and of other national/geographic provenance (Americans, Canadians from specific provinces, urban residents); 2) international travelers; 3) people who do not respect the preventive measures to contain the pandemic; and 4) people who question or criticize the scientific discourses about COVID-19. Our analysis revealed an "othering process" common in times of pandemic. Our analysis of editorial cartoons in Canada also uncovered a moralization around the respect of the counter measures against COVID-19. These editorial cartoons largely divide the population into two groups: 1) "virtuous" people who are "selfless" and "smart" and who respect the public health preventive measures; 2) those who are "immoral", "self-centered", "silly" and even "stupid", who do not respect the recommended measures to prevent the transmission of COVID-19. While negatively portraying these individuals may help promote adherence to the recommended measures, it also can exacerbate polarization. Analyzing editorial cartoons can be a useful approach to rapidly gather information on attitudes and feelings in the public at a specific time and place.

Background: The influx of over 1.3 million refugees in Uganda, with over 10% settling in the capital city Kampala, challenges the ability of urban refugees to access Sexual and Reproductive Health services (SRH) and family planning (FP) amidst the multiple uncertainties of a precarious everyday life. Utilization of SRH services remains low among urban refugees despite the fact that these services are essential to those of reproductive age and vulnerable to unwanted pregnancies and its consequences and contracting sexually transmitted infections (STIs) including HIV. Mildmay Uganda conducted a multimethod outreach program to establish the predictors of access to SRH services by urban refugees in Kampala city. This paper reports on social demographic characteristics that influenced the uptake of SRH services by urban refugees.Methods: A participatory, gender based, community-led, empowerment approach known as Gender Action Learning Systems (GALS) was employed to deliver SRH including family planning services to urban refugees in Kampala between March 2018 and September 2019. Urban refugees enrolled in GALS were interviewed at the beginning and end of the GALS intervention, where both qualitative and quantitative data were collected. Univariate, bivariate, and multivariate analyses were conducted to determine social demographic factors influencing the uptake of SRH services by urban refugees.Results: The​ ​study enrolled 867 participants, with 605 remaining to the end. Median age was 29 (IQR:22-36) years with a standard deviation of 10.7, 52% of the participants had never married. Retention in the study of the sexually active age cohort of primary interest (15 -34) was higher than the 35-54 cohort for both men and women. There were significant associations between SRH use and age, religion and education level among the urban refugees. Pentecostal religion (Adjusted OR 7.9; 3.5-18) and education level of primary (Adjusted OR 3.4; 1.1-11) were associated with uptake of SRH and FP. Conclusion: The participatory, peer-led community approach to delivering SRH services to urban refugees in this research project boosted uptake by the refugees and supported its successful completion and ability to address previously unknown predictors. A continuous awareness campaign using tested models such as GALS to promote services to refugees is needed to successfully integrate newcomers into Uganda’s general healthcare services.

How do postgenomic innovations emerge and become legitimate? Proteomics, a frequently utilized postgenomic technology, provides a valuable case study of the sociotechnical strategies used by an emergent scientific field to establish its legitimacy and assert political power. Chief among these strategies is standard making, an inherently political process that requires examination through a critical social science lens. We report in this study an original case study from interviews with proteomics scientists and observations at conferences of the Human Proteome Organization and Australasian Proteomics Society over a 5-year period (2011-2015). The study contributes new knowledge on how an emerging postgenomic science uses standard-setting practices to politically legitimize a hitherto contested technology. Drawing on legitimacy theory, we show how proteomics scientists and organizations used standards as strategic tools to establish the legitimacy of this postgenomic field and affirm that proteomics can generate verifiable and reproducible results, thereby establishing it as a legitimate scientific field. Notably, legitimacy can be leveraged, at the same time, to maximize political power vis-à-vis other fields of science and as such embodies power relationships. These data collectively inform the broader context, in which postgenomic innovations emerge and legitimize, both technically and politically, through standards making. These findings have relevance for the design of next generation technology policies by demonstrating that standards are not "just" standards or neutral constructs but also tools to leverage political power of and by science and innovation actors, as shown in this case study of the emerging early phase of proteomics from 2011 to 2015.

Global vaccine development is driven by logics that can run counter to local understandings, needs, and contexts. In a global industrial complex, dependent on financial market logics that prioritiz...

Uptake of vaccination during pregnancy in Canada is lower than comparator countries. A recommendation from a trusted perinatal healthcare provider is a key opportunity to promote vaccine uptake and improve confidence. This study aims to identify barriers and opportunities to vaccination in midwifery care. Seventeen semi-structured telephone interviews with practicing midwives, educators and public health professionals with immunization training experiences were conducted. Documents pertaining to the midwifery profession (approx. 50) were reviewed. Inductive thematic analysis identified logistical, interprofessional, and information barriers preventing Canadian midwives from administering vaccines and counseling clients about vaccination, as well as opportunities to address each barrier. Key interventions at the level of logistics, training, and client information materials would help address barriers to the integration of midwives into the provision and recommendation of vaccines in perinatal care across Canada.

Little is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate.Observation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants' stories to develop two ideal portraits based on "composite characters" based on study participants features. These provide ethnographically rich details of participants' meaningful social worlds while protecting individual identities.Ten of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation.Our findings support Fisher's argument of "structural coercion" in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie "under consent" of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North.

The World Health Organization (WHO) recognizes immunization as one of the most successful and effective public health interventions for saving lives. In developing a roadmap for prioritizing use of the coronavirus disease 2019 (COVID-19) vaccines in the context of limited supply, WHO highlighted the importance of a values (ethical principles) framework. Immunization does need to be subject to independent ethical scrutiny of vaccine research data, manufacturing practices, the legal and ethical assurance of informed consent, and also social justice issues with respect to program equity, including right to access. An ethics review of Australia’s immunization program was reported in 2012. This CANVax (Canadian Vaccination Evidence Resource and Exchange Centre) Brief offers an ethics review of immunization in Canada using the criteria utilized for Australia.

Background In the Global Vaccine Action Plan 2017 Assessment Report, WHO's SAGE noted need to understand ways in which legislation and regulation are used to advance or undermine immunization. The NITAG Environmental Scan Project sought to address this in a pilot study. Methods Data was collected via a secure online survey of GNN members (40 countries Sept 2018). Respondents reporting a mandatory element were asked: (1) what vaccinations were required by law; and (2) what population groups were subject to mandates; (3) what grounds, if any, were available for requesting exemptions. Results 28 (70%) countries responded, representing every WHO region and World Bank income level. While mandatory immunization programs / elements within broader NIPs were relatively common, jurisdictions varied with respect to immunizations required, population groups affected, grounds for exemptions, and penalties for non-compliance. We observed some loose associations with geography and income level. Children were the most common population group subject to mandates at some stage of childhood development (28/28); healthcare workers were second (8/15 (53%)). Sanctions for failure to immunize varied broadly, ranging from no penalty, to loss of access to social services e.g. admission to school, monetary fines, and incarceration. A variance between countries as to how strictly immunization mandates are enforced was noted. Conclusions A variety of approaches existed ranging from Narrow/Permissive to Broad/ Inclusive in scope with enforcement mapping loosely to this continuum from Loose/Permissive to Tight/Coercive. Jurisdictions with few/no vaccines mandated, and few/no target groups identified, Loose approach is expected; for those closer to Broad approach, Tighter controls expected. Coercive measures may be 'positive' (vaccination as a gateway to public services, with possible work-arounds), or 'negative' (failure to vaccinate = penalties).

Vaccine hesitancy-the reluctance to receive recommended vaccination because of concerns and doubts about vaccines-is recognized as a significant threat to the success of vaccination programs and has been associated with recent major outbreaks of vaccine-preventable diseases. Moreover, the association between complementary and alternative medicine (CAM) use and vaccine hesitancy and/or refusal has been frequently reported in the literature. To date, significant gaps persist in our understanding of contemporary Canadian CAM providers' beliefs regarding vaccination and how socio-professional influences may shape their vaccine-related attitudes and behaviours. To address the latter gap, the current study aims to explore the content of professional guidelines, recommendations and other discourses among CAM providers as they concern vaccination by analyzing both academic, peer-reviewed literature and Canadian organizational webpages prepared by and/or for practicing chiropractors, naturopaths and homeopaths. In the academic literature, we identified a number of complex and diverging views on vaccination that spanned topics of effectiveness; safety; theoretical, empirical, and ethical soundness; political justifiability; and compatibility with CAM philosophy and professional boundaries. However, in its current state the CAM literature cannot be described in broad strokes as being either pro- or anti-vaccination without considering finer areas of disagreement. Compared to the academic literature, which focuses more on the conceptual and evidentiary basis of vaccination, a greater proportion of vaccine-related content on Canadian CAM organizations' webpages seems to be dedicated to offering specific directives and prescriptions to providers. Guidelines and standards of practice address a number of issues, including vaccine administration, counsel, education and marketing. As CAM organizations further evolve in Canada and elsewhere as part of a broader "professionalization" initiative, greater attention will need to be directed at their role in shaping providers' beliefs and practices that both support and undermine vaccine promotion efforts.

For control of COVID-19, community immunity is required, necessitating widespread immunization. COVID-19 vaccines are coming to Canada, with the government announcing in August 2020 agreements with four different companies for their COVID-19 vaccine if their trials are successful. Never before has public health had to rapidly develop a vaccine introduction program for multiple new but differing vaccines with the added pressure that the program is needed across all ages and in all Canadian communities and there is high probability of not enough vaccine to go around at the start. Traditional public health vaccine introduction planning will need to be both accelerated and more comprehensive to ensure optimal uptake across the country. This overview highlights a number of points for consideration by public health in their planning for COVID-19 vaccines before these COVID-19 vaccines are available, once they are available, once supplies are plentiful, and throughout the vaccine program. Targeted and tailored communications are key elements needed to reach and positively influence diverse communities, regions, ages, languages, education levels and lived experiences.RéSUMé: Pour contrôler la pandémie de la COVID-19, une immunité de groupe est requise, ce qui nécessite de la vaccination à grande échelle. Des vaccins contre la COVID-19 seront bientôt disponibles au Canada, le gouvernement ayant annoncé en août 2020 des ententes pour obtenir les vaccins de quatre compagnies différentes si leurs essais sont couronnés de succès. Jamais auparavant la santé publique a eu à préparer rapidement l’introduction d’un nouveau programme avec plusieurs nouveaux vaccins, sans compter la pression supplémentaire liée au fait que le programme visera tous les groupes d’âges, devra rejoindre l’ensemble des communautés canadiennes et qu’il n’y aura probablement pas suffisamment de vaccins pour tous au moment de démarrer le programme. Les stratégies de santé publique pour l’introduction de programme de vaccination devront à la fois être accélérées et plus détaillées pour assurer une couverture vaccinale optimale à travers le pays. Cet article survole différents éléments à considérer par les autorités de santé publique dans la planification des programmes de vaccination contre la COVID-19 avant que les vaccins soient disponibles, lorsqu’ils le seront, lorsque l’approvisionnement en vaccins sera abondant et à travers le programme de vaccination. Des communications adaptées et ciblées sont des éléments essentiels pour rejoindre et influencer positivement les Canadiens provenant de différentes communautés et régions et ayant différents âges, langues maternelles, niveaux de scolarité et expériences.

Background In 2018, the Canadian National Advisory Committee on Immunization and the Society of Obstetricians and Gynaecologists of Canada recommended a single dose of tetanus toxoid, reduced diphtheria toxoid and reduced acellular pertussis (Tdap) vaccine in every pregnancy. To understand how perinatal health care providers in Canada are translating recent recommendations for universal antenatal Tdap vaccine into routine clinical practice, we examined health care providers' perceptions of what influences their ability to recommend and provide Tdap vaccine consistently to pregnant women. Methods Between June 2018 and July 2019, we conducted semistructured telephone interviews with perinatal health care providers (nurses, midwives, family physicians and obstetricians) from 5 provinces (British Columbia, Manitoba, Ontario, Quebec and Nova Scotia) representing diverse educational experiences, practice settings and models of care. We analyzed the data using interpretive description. Results We interviewed 44 perinatal health care providers (13 family physicians, 12 midwives, 10 obstetricians and 9 nurses) practising in a variety of settings. Health care providers' ability to recommend and provide antenatal Tdap vaccine was strongly influenced by structural constraints in the Canadian perinatal health care system. The participants' clinical training varied, which resulted in different knowledge and practices. Participants felt hindered by a lack of lay information resources. Consistent and convenient vaccine access was perceived to be key to promoting confidence and encouraging uptake, yet antenatal Tdap vaccine was not easily accessible for all women. Interpretation Our findings suggest that Canada's fragmented health care model has a detrimental effect on health care providers' ability to recommend and ensure access to antenatal Tdap vaccine. Lessons from this study are pertinent to the implementation of successful pertussis vaccine programs and future pregnancy vaccination initiatives.

Background Influenza immunization is recommended in pregnancy to prevent severe infections in pregnant women and newborns, yet vaccine uptake remains low. Studies suggest that cautionary language in vaccine product monographs regarding safety and use in pregnancy affects health care providers' perceptions of vaccine safety and how they counsel pregnant women. Objective To conduct a qualitative analysis of health care provider perceptions of the safety of inactivated influenza vaccines and their recommendations for use in pregnancy based on product monograph language statements. Methods Health care providers were recruited at two international health conferences and from teaching programs in Ethiopia, Ghana, Uganda, and Laos during September and October 2015. After reading the product monograph excerpts for three licensed inactivated influenza vaccines, participants completed a ten-item online survey with quantitative and qualitative components that captured perceptions of vaccine safety. Results Health care providers identified a lack of trust in manufacturers' and product monograph information. They perceived product monograph language as ambiguous and not "up-to-date" with current evidence. Health care providers wanted product monograph language that clearly conveyed evidence for the risks and benefits of the vaccine in an understandable manner. Conclusion This study suggests that adopting best practices in the wording of product monographs would help to support evidence-based use of vaccines in pregnant women.

Le projet Vaccins Meningite a permis a des millions d’Africains de disposer d’un vaccin peu couteux, le MenAfriVac®, grâce a un transfert de technologie. Les recits de la biomedecine en ont fait une histoire a succes, un mythe sociotechnique anonyme et collectif dans lequel le MenAfriVac® revet une efficacite magique. Les promoteurs du vaccin ont choisi la rhetorique de l’elimination de la meningite par un vaccin, occultant un contexte epidemiologique plus complexe, notamment la persistance d’epidemies, docu-mentees et dues a des serogroupes autres que ceux cibles par le MenAfriVac®. Cette contribution a pour objectif d’analyser la construction du succes autour du vaccin et les paradoxes qui poussent a etre prudent face aux initiatives de sante mondiale plebiscitant une solution universelle et expeditive par la technologie. Nous verrons que la solution par le vaccin repose sur des repre-sentations cles de ce qu’est un succes. Ensuite, la contribution souligne que le MenAfriVac® est revelateur d’un type de « solution globale » privilegiant un emiettement des priorites et une visee a court terme de la sante publique.

Background The World Health Organization recommends immunization with inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine during pregnancy. Yet, product labelling information for IIV and Tdap sends a different message. In a previous study, we developed evidence-based statements about vaccination in pregnancy that could be included in product information. This study compares healthcare providers' perceptions of the revised statements to those currently used in vaccine product labelling information. Methods A 30-item online survey with qualitative and quantitative components was distributed to Canadian maternal healthcare providers via professional organizations and public health. Participants read excerpts from revised and existing IIV and Tdap product labelling information and answered questions about how they perceived the safety and effectiveness of the vaccines, whether they would recommend each vaccine during pregnancy, and which statements they preferred. Results From June to August 2018, 449 healthcare providers completed the survey, including physicians (45%), nurses (24%), midwives (27%) and others (5%). Most participants perceived the vaccines to be safe and effective based on the revised statements. Over twice as many participants said they would recommend the IIV and Tdap vaccines in pregnancy based on the revised rather than the existing statements (64% versus 21% for IIV and 63% versus 27% for Tdap). Most participants selected that the revised statements better explained the risks and benefits of vaccination in pregnancy (65% versus 21% for IIV; 51% versus 27% for Tdap). Qualitative comments highlighted the strengths of the revised statements and areas for improvement. Conclusions The majority of participants demonstrated preferences for the revised IIV and Tdap product label statements over the existing statements. Comments suggested the revised statements include improvements to the evidence-base and readability. Involving stakeholders improved the development of product labelling information, but further improvement is needed to support the evidence-based use of vaccines in pregnancy.

The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common assumption that the research and development for innovative therapeutic products and vaccines is best carried out by the private sector. Using internal government documents obtained through an access to information request, we analyze the development of rVSV-ZEBOV by researchers at Canada’s National Microbiology Laboratory beyond its patenting and licensing to a biotech company in the United States in 2010. According to government documentation, the company failed to make any progress toward a phase 1 clinical trial until after the WHO Public Health Emergency of International Concern freed substantial donor and public funds for the vaccine’s further development. The development of rVSV-ZEBOV, from sponsoring early stage research through to carrying out clinical trials during the epidemic, was instead the result of the combined efforts of the Canadian government, its researchers, and other publicly funded institutions. This case study of rVSV-ZEBOV underscores the significant public contribution to the R&D of vaccines even under conditions of precarity, and suggests that an alternative approach to generating knowledge and developing interventions, such as open science, is required in order to fully realize the public sector’s contribution to improved global health.

In 2017, the Strategic Advisory Group of Experts on Immunization's Assessment Report of the Global Vaccine Action Plan noted the need to "better document the ways in which legislation and regulations have been used to promote or undermine immunization at the national level". Despite National Immunization Technical Advisory Groups (NITAGs) now existing in over 134 countries worldwide, there has been very little academic consideration of their legal underpinnings. In this paper, we compare the legal foundations and authority of 28 NITAGs from the six WHO Regions. All are members of the Global NITAG Network. We categorize the NITAGs based on their legal foundation and on the authority granted to them by their government, organizing them into a taxonomy of models. We then propose legal considerations for governments contemplating establishing or reforming a NITAG.

Background National Regulatory Authorities approve the indications for vaccine use in the product information. Occasionally, National Immunization Technical Advisory Groups (NITAGs) make off-label recommendations for use in different age groups, populations, and dosing schedules from the product information. We sought to determine the rationale, policies and procedures for NITAG off-label recommendations. Methods We conducted an environmental scan of Global NITAG Network members, immunization program managers and regulators in 38 high-, middle- and low-income countries. Participants completed an online survey regarding policies, procedures, and legislation governing development of off-label recommendations. A sub-sample of respondents met for a focus group and interviews which were analyzed qualitatively. Results Thirty-four people responded from 26/38 (68%) countries surveyed; 76% of respondents were NITAG members or immunization program managers. Recommendations for off-label vaccine use were made in 14/26 (54%) countries; the NITAG made those recommendations in 8/14 (57%) countries. Reasons for off-label vaccine recommendations included response to disease outbreaks or vaccine shortages. Only one country had standard operating procedures for developing off-label recommendations while 6/14 (43%) countries had policies for implementing off-label recommendations. Nine respondents from 8 countries agreed to participate in a focus group (n = 6) or individual interviews (n = 3). Barriers to off-label recommendations included legal concerns, lack of standard definition for off-label use, and manufacturer reluctance to update product information. Facilitators included confidence in the decision-making process, and transparency of open communication among stakeholders. Conclusions Best practice guidelines are needed that define off-label use and outline a transparent, evidence-based approach to develop off-label recommendations.

Background Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy. Purpose To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels. Methods We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus. Principal results Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada. Conclusions The revised statements for IIV and Tdap aligned with workshop participants’ goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.

The primary health care approach advanced at Alma Ata to address social determinants of health was replaced by selective health care a year later at Bellagio. Subsequently, immunization was endorsed as a cost-effective technical intervention to combat targeted infectious diseases. Multilateral efforts to collaborate on immunization as a universal public health good ambiguously capture the interests of the world's governments as well as private, public, and not-for-profit institutions. Global assemblages of scientists, governments, industry and nongovernmental organizations now work in public-private partnerships to develop and make essential vaccines accessible, with vaccines marketed as single fix solutions for global health. Drawing from ethnographic fieldwork in France and Burkina Faso that followed the development, regulation, and implementation of the group A meningococcal conjugate vaccine for sub-Saharan Africa, in this article I describe events during and after the development of MenAfriVac. A technological success narrative steeped in collaborative capitalist rhetoric disguises neglected health care systems.

Despite robust evidence that routine immunization is effective and safe, some parents refuse some or all vaccines for their children. In 2007, concern that Canadian paediatricians and family physicians might be considering dismissal of vaccine refusers from their practices prompted an ethical, legal, and public health analysis which concluded that dismissal was professionally problematic. We now reassess this important issue in the Canadian context updating ethical, legal, and public health considerations highlighting changes since 2007. In light of the recent strengthening of Ontario's school immunization requirements that include stiffer steps to qualify for a medical, conscience, or religious belief exemption, physicians and health care workers may be under more pressure from vaccine refusers in their practice leading some to contemplate dismissal or even consider no longer offering immunizations at all in their practice. Given the challenges that vaccine refusers may present, we offer an overview for managing vaccine refusal by parents/patients in a medical practice.

Richard Lewontin proposed that the ability of a scientific field to create a narrative for public understanding garners it social relevance. This article applies Lewontin's conceptual framework of the functions of science (manipulatory and explanatory) to compare and explain the current differences in perceived societal relevance of genetics/genomics and proteomics. We provide three examples to illustrate the social relevance and strong cultural narrative of genetics/genomics for which no counterpart exists for proteomics. We argue that the major difference between genetics/genomics and proteomics is that genomics has a strong explanatory function, due to the strong cultural narrative of heredity. Based on qualitative interviews and observations of proteomics conferences, we suggest that the nature of proteins, lack of public understanding, and theoretical complexity exacerbates this difference for proteomics. Lewontin's framework suggests that social scientists may find that omics sciences affect social relations in different ways than past analyses of genetics.

Background:In Canada and elsewhere, research policies require researchers to secure consent from a legally authorized representative (LAR) for prospective participants unable to consent. Few jurisdictions, however, offer a clear legislative basis for LAR identification. We investigated Canadian researchers’ practices regarding the involvement of decisionally incapacitated participants and tested whether reported practices were associated with (1) researchers’ understanding of the law on third-party authorization of research and (2) their comfort with allowing a family member to consent on behalf of an incapacitated relative.Methods:We surveyed researchers in aging from four Canadian provinces about their practices with prospective participants deemed incapable of consent, their understanding of relevant law, and comfort with family consent for research purposes. Understanding and comfort were measured with research vignettes that briefly described hypothetical studies in which an adult who lacks the capacity to consent was invited to participate.Results:Many respondents reported soliciting consent from a family member (45.7% for low-risk studies and 10.7% for serious risks studies), even in jurisdictions where such authority is uncertain at law. Researchers’ tendency to solicit family consent was associated with their comfort in doing so, but not with their understanding of the law on substitute consent for research.Conclusions:Findings underscore the need to clarify who may authorize an incapacitated adult's participation in research. Meanwhile, people should inform their relatives of their desire to participate or not in research in the event of incapacity, given researchers’ tendency to turn to family for consent, even where not supported by law.

This manuscript is a post-print edition. The final version was published in the journal Ethics in Biology, Engineering and Medicine: An International Journal. Please cite accordingly. The final publisher's version is available at: http://dl.begellhouse.com/journals/6ed509641f7324e6,50de6dfe406dbd9f,2f84f7797f9ce1cb.html

Proteomics is one of the pivotal next-generation biotechnologies in the current "postgenomics" era. Little is known about the ways in which innovative proteomics science is navigating the complex socio-political space between laboratory and society. It cannot be assumed that the trajectory between proteomics laboratory and society is linear and unidirectional. Concerned about public accountability and hopes for knowledge-based innovations, funding agencies and citizens increasingly expect that emerging science and technologies, such as proteomics, are effectively translated and disseminated as innovation in society. Here, we describe translation strategies promoted in the knowledge translation (KT) and science communication literatures and examine the use of these strategies within the field of proteomics. Drawing on data generated from qualitative interviews with proteomics scientists and ethnographic observation of international proteomics conferences over a 5-year period, we found that proteomics science incorporates a variety of KT strategies to reach knowledge users outside the field. To attain the full benefit of KT, however, proteomics scientists must challenge their own normative assumptions and approaches to innovation dissemination-beyond the current paradigm relying primarily on publication for one's scientific peers within one's field-and embrace the value of broader (interdisciplinary) KT strategies in promoting the uptake of their research. Notably, the Human Proteome Organization (HUPO) is paying increasing attention to a broader range of KT strategies, including targeted dissemination, integrated KT, and public outreach. We suggest that increasing the variety of KT strategies employed by proteomics scientists is timely and would serve well the omics system sciences community.