Biopharmaceutical Financialization and Public Funding of Medical Countermeasures (MCMs) in Canada During the COVID-19 Pandemic.

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 (R&D), including the dominance of private sector involvement in an intellectual property (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, 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: 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 into developing COVID-19 MCMs safeguard affordable and transparent access to the products of publicly funded research, we found that access policies on IP 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.

From high hopes to disenchantment: A qualitative analysis of editorial cartoons on COVID-19 vaccines in Canadian newspapers.

In Canada, the first COVID-19 vaccine was approved for use in December 2020, marking the beginning of a large vaccination campaign. The campaign was not only unprecedented in terms of reach, but also with regards to the amount of information about vaccines that circulated in traditional and social media. This study's aim was to describe COVID-19 vaccine related discourses in Canada through an analysis of editorial cartoons. We collected 2172 cartoons about COVID-19 published between January 2020 and August 2022 in Canadian newspapers. These cartoons were downloaded and a first thematic analysis was conducted using the WHO-EPIWIN taxonomy (cause, illness, treatment, interventions, and information). From this, 389 cartoons related to COVID-19 vaccines were identified under the treatment category. These were subjected to a second thematic analysis to assess main themes (e.g., vaccine development, campaign progress, etc.), characters featured (e.g., politicians, public figures, public) and position with respect to vaccine (favorable, unfavorable, neutral). Six main themes emerged: Research and development of vaccines; Management of the vaccination campaign; Perceptions of and experiences with vaccination services; Measures and incentives to increase COVID-19 vaccine uptake; Criticism of the unvaccinated; and Effectiveness of vaccination. Our analysis revealed a shift in attitudes toward COVID-19 vaccination from high hopes to disenchantment, which may reflect some vaccine fatigue. In the future, public health authorities could face some challenges in maintaining confidence and high COVID-19 vaccine uptake.

"I Want People to Be Able to Make an Informed Choice": How Quebec naturopaths discuss vaccination in their practice.

Health care providers' recommendations can play an important role in individuals' vaccination decisions. Despite being one of the most popular complementary and alternative medicine (CAM), naturopathy is understudied in relation to vaccination decisions. We sought to address this gap through this study of vaccination perspectives of naturopathy practitioners in the province of Quebec, Canada. We conducted in-depth interviews with 30 naturopaths. Thematic analysis was conducted. Main themes were developed deductively (i.e., based on prior literature) and expanded through inductive coding of the data. Participants noted that they discuss vaccination in their practice, but only when clients asked questions or wanted advice. Naturopaths described refraining from explicitly recommending for or against vaccination. Instead, they focus on empowering their clients to make their own informed decision regarding vaccination. Most participants noted that they direct clients towards sources of information so that clients could decide for themselves, but some mentioned they discussed with clients what they considered to be risks associated with vaccination, as well as its benefits. These discussions were framed through a personalized and individual approach with clients.

"Ultimately, the choice is theirs": Informed choice vaccine conversations and Canadian midwives.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. DISCUSSION: 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.

An equitable vaccine delivery system: Lessons from the COVID-19 vaccine rollout in Canada.

BACKGROUND: The COVID-19 pandemic exacerbated existing health disparities and disproportionately affected vulnerable individuals and communities (e.g., low-income, precariously housed or in institutional settings, racialized, migrant, refugee, 2SLBGTQ+). Despite their higher risk of infection and sub-optimal access to healthcare, Canada's COVID-19 vaccination strategy focused primarily on age, as well as medical and occupational risk factors. METHODS: We conducted a mixed-methods constant comparative qualitative analysis of epidemiological data from a national database of COVID-19 cases and vaccine coverage in four Canadian jurisdictions. Jurisdictional policies, policy updates, and associated press releases were collected from government websites, and qualitative data were collected through 34 semi-structured interviews of key informants from nine Canadian jurisdictions. Interviews were coded and analyzed for themes and patterns. RESULTS: COVID-19 vaccines were rolled out in Canada in three phases, each accompanied by specific challenges. Vaccine delivery systems typically featured large-venue mass immunization sites that presented a variety of barriers for those from vulnerable communities. The engagement and targeted outreach that featured in the later phases were driven predominantly by the efforts of community organizations and primary care providers, with limited support from provincial governments. CONCLUSIONS: While COVID-19 vaccine rollout in Canada is largely considered a success, such an interpretation is shaped by the metrics chosen. Vaccine delivery systems across Canada need substantial improvements to ensure optimal uptake and equitable access for all. Our findings suggest a more equitable model for vaccine delivery featuring early establishment of local barrier-free clinics, culturally safe and representative environment, as well as multi-lingual assistance, among other vulnerability-sensitive elements.

Unmasking the Twitter Discourses on Masks During the COVID-19 Pandemic: User Cluster-Based BERT Topic Modeling Approach.

Background: The COVID-19 pandemic has spotlighted the politicization of public health issues. A public health monitoring tool must be equipped to reveal a public health measure's political context and guide better interventions. In its current form, infoveillance tends to neglect identity and interest-based users, hence being limited in exposing how public health discourse varies by different political groups. Adopting an algorithmic tool to classify users and their short social media texts might remedy that limitation. Objective: We aimed to implement a new computational framework to investigate discourses and temporal changes in topics unique to different user clusters. The framework was developed to contextualize how web-based public health discourse varies by identity and interest-based user clusters. We used masks and mask wearing during the early stage of the COVID-19 pandemic in the English-speaking world as a case study to illustrate the application of the framework. Methods: We first clustered Twitter users based on their identities and interests as expressed through Twitter bio pages. Exploratory text network analysis reveals salient political, social, and professional identities of various user clusters. It then uses BERT Topic modeling to identify topics by the user clusters. It reveals how web-based discourse has shifted over time and varied by 4 user clusters: conservative, progressive, general public, and public health professionals. Results: This study demonstrated the importance of a priori user classification and longitudinal topical trends in understanding the political context of web-based public health discourse. The framework reveals that the political groups and the 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 China were found to drive the discourse. It also shows limited participation of public health professionals compared with other users. Conclusions: We conclude by discussing the importance of a priori user classification in analyzing web-based discourse and illustrating the fit of BERT Topic modeling in identifying contextualized topics in short social media texts.

Public health communication in Canada during the COVID-19 pandemic.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Suitable but requiring support: How the midwifery model of care offers opportunities to counsel the vaccine hesitant pregnant population.

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.

Nova Scotia Strong: why communities joined to embrace COVID-19 public health measures.

OBJECTIVE: To explore Nova Scotian experiences, barriers, and facilitators associated with pandemic public health measures (PHM), including COVID-19 vaccination. METHODS: 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. RESULTS: 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 Confidence & Hesitancy. 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. CONCLUSION: 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.

Deferring Risk: Limitations to the Evidence in Product Labels for Vaccine Use in Pregnancy.

Background: The gaps in clinical trial evidence about vaccination in pregnancy have serious implications for health care worker and public misunderstandings. Contradictions between National Immunization Technical Advisory Group (NITAG) recommendations and regulatory product labeling information contribute to misinformation about vaccine safety and effectiveness. Methods: A mixed methods approach that included a stakeholder consensus decision-making workshop and a national survey of Canadian health care providers (HCPs). Results: We identified knowledge gaps and serious limitations concerning the information in vaccine product labels. Stakeholders were troubled that some HCPs rely on regulatory product labels to inform their decisions without knowing their limitations in content. Our survey showed that HCPs were uncertain about the purpose of product labels and the evidence contained in them. Over a third of respondents incorrectly thought that product labels and NITAG recommendations are based on the same evidence and that the information they contain is regularly updated. Conclusions: Applying social risk theories, we show how such gaps in information defer responsibility for decisions about disease risk and vaccine safety from regulatory agencies and vaccine manufacturers onto HCPs and their clients. This may be especially relevant for COVID-19 and other emerging vaccines that are initially authorized for conditional or emergency use, and especially in understudied populations such as pregnant people. More frequent updating and alignment of robust, unbiased, and independently reviewed clinical trial and postmarket safety and effectiveness evidence with NITAG recommendations would allay HCP and public misunderstandings.

The unintended consequences of COVID-19 vaccine policy: why mandates, passports and restrictions may cause more harm than good.

Vaccination policies have shifted dramatically during COVID-19 with the rapid emergence of population-wide vaccine mandates, domestic vaccine passports and differential restrictions based on vaccination status. While these policies have prompted ethical, scientific, practical, legal and political debate, there has been limited evaluation of their potential unintended consequences. Here, we outline a comprehensive set of hypotheses for why these policies may ultimately be counterproductive and harmful. Our framework considers four domains: (1) behavioural psychology, (2) politics and law, (3) socioeconomics, and (4) the integrity of science and public health. While current vaccines appear to have had a significant impact on decreasing COVID-19-related morbidity and mortality burdens, we argue that current mandatory vaccine policies are scientifically questionable and are likely to cause more societal harm than good. Restricting people's access to work, education, public transport and social life based on COVID-19 vaccination status impinges on human rights, promotes stigma and social polarisation, and adversely affects health and well-being. Current policies may lead to a widening of health and economic inequalities, detrimental long-term impacts on trust in government and scientific institutions, and reduce the uptake of future public health measures, including COVID-19 vaccines as well as routine immunisations. Mandating vaccination is one of the most powerful interventions in public health and should be used sparingly and carefully to uphold ethical norms and trust in institutions. We argue that current COVID-19 vaccine policies should be re-evaluated in light of the negative consequences that we outline. Leveraging empowering strategies based on trust and public consultation, and improving healthcare services and infrastructure, represent a more sustainable approach to optimising COVID-19 vaccination programmes and, more broadly, the health and well-being of the public.

Stigma and blame related to COVID-19 pandemic: A case-study of editorial cartoons in Canada.

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.

From sandbox to pandemic: Agile reform of Canadian drug regulation.

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.

Ethics check-up of public health immunization programs in Canada.

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.

Healthcare providers' interpretations of product labelling information developed through a consensus stakeholder approach.

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.

Under consent: participation of people with HIV in an Ebola vaccine trial in Canada.

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.

A public health timeline to prepare for COVID-19 vaccines in Canada.

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.

Immunization governance: Mandatory immunization in 28 Global NITAG Network countries.

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.

Vaccination discourses among chiropractors, naturopaths and homeopaths: A qualitative content analysis of academic literature and Canadian organizational webpages.

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.