What is the role of primary care in the COVID-19 vaccine roll-out and the barriers and facilitators to an equitable vaccine roll-out? A rapid scoping review of nine jurisdictions.

OBJECTIVES: This study aimed to: (1) examine the experience of nine global jurisdictions that engaged primary care providers (PCPs) to administer COVID-19 vaccines during the pandemic; (2) describe how vaccine hesitancy and principles of equity were incorporated in the COVID-19 vaccine roll-out strategies and (3) identify the barriers and facilitators to the vaccine roll-out. DESIGN: Rapid scoping review. DATA SOURCES: Searches took place in MEDLINE, CINAHL, Embase, the Cochrane Library, SCOPUS and PsycINFO, Google, and the websites of national health departments. Searches and analyses took place from May 2021 to July 2021. RESULTS: Sixty-two documents met the inclusion criteria (35=grey literature; 56% and 27=peer reviewed; 44%). This review found that the vaccine distribution approach started at hospitals in almost all jurisdictions. In some jurisdictions, PCPs were engaged at the beginning, and the majority included PCPs over time. In many jurisdictions, equity was considered in the prioritisation policies for various marginalised communities. However, vaccine hesitancy was not explicitly considered in the design of vaccine distribution approaches. The barriers to the roll-out of vaccines included personal, organisational and contextual factors. The vaccine roll-out strategy was facilitated by establishing policies and processes for pandemic preparedness, well-established and coordinated information systems, primary care interventions, adequate supply of providers, education and training of providers, and effective communications strategy. CONCLUSIONS: Empirical evidence is lacking on the impact of a primary care-led vaccine distribution approach on vaccine hesitancy, adoption and equity. Future vaccine distribution approaches need to be informed by further research evaluating vaccine distribution approaches and their impact on patient and population outcomes.

Identifying priority challenges and solutions for COVID-19 vaccine delivery in low- and middle-income countries: A modified Delphi study

Background The rapid implementation of global COVID-19 vaccination programs has surfaced many challenges and inequities, particularly in low- and middle-income countries (LMICs). However, there continues to be a lack of consensus on which challenges are global priorities for action, and how to best respond to them. This study uses consensus-based methods to identify and rank the most important challenges and solutions for implementation of COVID-19 vaccination programs in LMICs. Methods We conducted a three-round modified Delphi study with a global panel of vaccine delivery experts. In Round I, panelists identified broad topical challenges and solutions. Responses were collated and coded into distinct items. Through two further rounds of structured, iterative surveys panelists reviewed and ranked the identified items. Responses were analyzed qualitatively and quantitatively to achieve consensus on the most important COVID-19 vaccine delivery challenges and solutions. Results Of the 426 invited panelists, 96 completed Round I, 56 completed Round II, and 39 completed Round III. Across all three rounds there was equal representation by gender, and panelists reported work experience in all World Bank regions and across a variety of content areas and organizations. Of the 64 initially identified items, the panel achieved consensus on three challenges and 10 solutions. Challenges fell under themes of structural factors and infrastructure and human and material resources, while solutions also included items within themes of communication, community engagement, and access and planning, processes, and operations. Conclusion COVID-19 vaccine delivery is challenged by long-standing and structural inequities that disadvantage health service delivery in LMICs. These findings can, and should, be used by global health organizations to efficiently and optimally direct resources to respond to these key challenges and solutions.

Global inequity creates local insufficiency: A qualitative study of COVID-19 vaccine implementation challenges in low-and-middle-income countries

Introduction The COVID-19 pandemic has amplified pre-existing challenges to health promotion and care across the world, and particularly in low- and middle-income countries (LMICs). This qualitative study draws on data from a panel of immunisation experts and uses a novel framework of vaccine delivery domains to explore perspectives from those who live and work in these settings on the challenges to implementing COVID-19 vaccine programs in LMICs. Methods We conducted a thematic content analysis of 96 participant free text replies to questions from Round I of a three-round Delphi consensus study amongst global experts on COVID-19 vaccine implementation. Results Participant responses highlighted challenges to vaccine program implementation including issues related to equity;governance, decision-making, and financing;regulatory structures, planning, and coordination;prioritisation, demand generation, and communication;vaccine, cold chain, logistics, and infrastructure;service delivery, human resources, and supplies;and surveillance, monitoring, and evaluation. Conclusion We reflect on our findings in light of global efforts to address vaccine inequity and emphasise three key areas salient to improving vaccination efforts during novel infectious disease outbreaks: 1) Ensuring safe and sustainable service delivery in communities and at points of care;2) Strengthening systems for end-to-end delivery of vaccines, therapeutics, diagnostics, and essential supplies;3) Transforming structural paradigms towards vaccine equity.

Global inequity creates local insufficiency: A qualitative study of COVID-19 vaccine implementation challenges in low-and-middle-income countries.

INTRODUCTION: The COVID-19 pandemic has amplified pre-existing challenges to health promotion and care across the world, and particularly in low- and middle-income countries (LMICs). This qualitative study draws on data from a panel of immunisation experts and uses a novel framework of vaccine delivery domains to explore perspectives from those who live and work in these settings on the challenges to implementing COVID-19 vaccine programs in LMICs. METHODS: We conducted a thematic content analysis of 96 participant free text replies to questions from Round I of a three-round Delphi consensus study amongst global experts on COVID-19 vaccine implementation. RESULTS: Participant responses highlighted challenges to vaccine program implementation including issues related to equity; governance, decision-making, and financing; regulatory structures, planning, and coordination; prioritisation, demand generation, and communication; vaccine, cold chain, logistics, and infrastructure; service delivery, human resources, and supplies; and surveillance, monitoring, and evaluation. CONCLUSION: We reflect on our findings in light of global efforts to address vaccine inequity and emphasise three key areas salient to improving vaccination efforts during novel infectious disease outbreaks: 1) Ensuring safe and sustainable service delivery in communities and at points of care; 2) Strengthening systems for end-to-end delivery of vaccines, therapeutics, diagnostics, and essential supplies; 3) Transforming structural paradigms towards vaccine equity.

Identifying priority challenges and solutions for COVID-19 vaccine delivery in low- and middle-income countries: A modified Delphi study.

BACKGROUND: The rapid implementation of global COVID-19 vaccination programs has surfaced many challenges and inequities, particularly in low- and middle-income countries (LMICs). However, there continues to be a lack of consensus on which challenges are global priorities for action, and how to best respond to them. This study uses consensus-based methods to identify and rank the most important challenges and solutions for implementation of COVID-19 vaccination programs in LMICs. METHODS: We conducted a three-round modified Delphi study with a global panel of vaccine delivery experts. In Round I, panelists identified broad topical challenges and solutions. Responses were collated and coded into distinct items. Through two further rounds of structured, iterative surveys panelists reviewed and ranked the identified items. Responses were analyzed qualitatively and quantitatively to achieve consensus on the most important COVID-19 vaccine delivery challenges and solutions. RESULTS: Of the 426 invited panelists, 96 completed Round I, 56 completed Round II, and 39 completed Round III. Across all three rounds there was equal representation by gender, and panelists reported work experience in all World Bank regions and across a variety of content areas and organizations. Of the 64 initially identified items, the panel achieved consensus on three challenges and 10 solutions. Challenges fell under themes of structural factors and infrastructure and human and material resources, while solutions also included items within themes of communication, community engagement, and access and planning, processes, and operations. CONCLUSION: COVID-19 vaccine delivery is challenged by long-standing and structural inequities that disadvantage health service delivery in LMICs. These findings can, and should, be used by global health organizations to efficiently and optimally direct resources to respond to these key challenges and solutions.

The Granting of Emergency Use Designation to COVID-19 Candidate Vaccines : Implications for COVID-19 Vaccine Trials

An efficacious COVID-19 vaccine is currently the world's leading research priority. Several nations have indicated that if there is a compelling case for use of a vaccine before it is licensed, they would be prepared to authorise its emergency use or conditional approval on public health grounds. As of Dec 1, 2020, several developers of leading COVID-19 candidate vaccines have indicated that they have applied, or intend to apply, for emergency authorisation for their vaccines. Should candidate vaccines attain emergency use designation and be programmatically deployed before their phase 3 trials conclude, such a strategy could have far reaching consequences for COVID-19 vaccine research and the effective control of the COVID-19 pandemic. These issues merit careful consideration.

WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations.

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

Top five ethical lessons of COVID-19 that the world must learn.

As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) and prepare for and experience surges in cases, it is important to identify the most crucial ethical issues that might lie ahead so that countries are able to plan accordingly. Some ethical issues are rather obvious to predict, such as the ethical issues surrounding the use of immunity certificates, contact tracing, and the fair allocation of vaccines globally. Yet, the most significant ethical challenge that the world must address in the next year and beyond is to ensure that we learn the ethical lessons of the first year of this pandemic. Learning from our collective experiences thus far constitutes our greatest moral obligation. Appreciating that decision-making in the context of a pandemic is constrained by unprecedented complexity and uncertainty, beginning in June 2020, an international group of 17 experts in bioethics spanning 15 countries (including low-, middle-, and high-income countries) met virtually to identify what we considered to be the most significant ethical challenges and accompanying lessons faced thus far in the COVID-19 pandemic. Once collected, the group met over the course of several virtual meetings to identify challenges and lessons that are analytically distinct in order to identify common ethical themes under which different challenges and lessons could be grouped. The result, described in this paper, is what this expert group consider to be the top five ethical lessons from the initial experience with COVID-19 that must be learned.

National primary care responses to COVID-19: a rapid review of the literature.

OBJECTIVE: The aim of this review, conducted in April 2020, is to examine available national primary care guidelines for COVID-19 and to explore the ways in which these guidelines support primary care facilities in responding to the demands of the COVID-19 pandemic. DESIGN: Rapid review and narrative synthesis. DATA SOURCES: PubMed, Embase and Google, as well as the websites of relevant national health departments, were searched from 1 January 2020 to 24 April 2020. ELIGIBILITY CRITERIA: Documents included must be issued by a national health authority, must be specific to COVID-19 care, directed at healthcare workers or managers, and must refer to the role of primary care in the COVID-19 response. RESULTS: We identified 17 documents from 14 countries. An adapted framework on primary care challenges and responses to pandemic influenza framed our analysis. Guidelines generally reported on COVID-19 service delivery and mostly made specific recommendations for ensuring continued delivery of essential primary care services through telehealth or other virtual care modalities. Few offered guidance to support surveillance as a public health function. All offered guidance on implementing outbreak control measures, largely through flexible and coordinated organisational models with partners from various sectors. There was a lack of guidance to support supply chain management and practice resilience in primary care, and lack of personal protective equipment represents a serious threat to the provision of quality care during the pandemic. CONCLUSIONS: Current national primary care guidelines for COVID-19 provide guidance on infection control and minimising the risk of spread in primary care practices, while supporting the use of new technology and coordinated partnerships. However, to ensure primary care practice resilience and quality of care are upheld, guidelines must offer recommendations on supply chain management and operational continuity, supported by adequate resources.

Learning Lessons from COVID-19 Requires Recognizing Moral Failures.

The most powerful lesson learned from the 2013-2016 outbreak of Ebola in West Africa was that we do not learn our lessons. A common sentiment at the time was that Ebola served as a "wake-up call"-an alarm which signalled that an outbreak of that magnitude should never have occurred and that we are ill-prepared globally to prevent and respond to them when they do. Pledges were made that we must learn from the outbreak before we were faced with another. Nearly five years later the world is in the grips of a pandemic of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19). It is therefore of no surprise that we are now yet again hearing that the COVID-19 pandemic serves as the "wake-up call" we need and that there are many lessons to be learned to better prepare us for future outbreaks. Will anything be different this time around? We argue that nothing will fundamentally change unless we truly understand and appreciate the nature of the lessons we should learn from these outbreaks. Our past failures must be understood as moral failures that offer moral lessons. Unless we appreciate that we have a defect in our collective moral attitude toward remediating the conditions that precipitate the emergence of outbreaks, we will never truly learn.

Publication Ethics During Public Health Emergencies Such as the COVID-19 Pandemic.

Public health emergencies require real-time, accurate information to guide effective responses. Rapid publication of information can, therefore, advance both the scientific validity and the social value of research conducted in these contexts. Consequently, medical journals place a high priority on rapidly publishing reports on these emergencies, which the media often report on to the public. Today, the focus is on the rapid publication of research related to the COVID-19 outbreak. Tomorrow, it might be an influenza pandemic or a crisis related to a vaping-related illness. (Am J Public Health. Published online ahead of print May 14, 2020: e1-e2. doi:10.2105/AJPH.2020.305686).