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In addition to burden of disease and vaccine characteristics, PHAC has expanded the mandate of NACI to include the systematic consideration of programmatic factors in developing evidence-based recommendations to facilitate timely decision-making for publicly funded vaccine programs at provincial and territorial levels.
The additional factors to be systematically considered by NACI include: economics, ethics, equity, feasibility, and acceptability. While systematic consideration of programmatic factors will be conducted using evidence-informed tools to identify distinct issues that could impact decision-making for recommendation development, only distinct issues identified as being specific to the vaccine or vaccine-preventable disease will be included.
People administering the vaccine should also be aware of the contents of the relevant product monograph s. Recommendations for use and papenburg information set out herein may differ from that set out in the product monograph s of the Canadian manufacturer s of the cost s. Manufacturer s have sought approval of the vaccine s and provided evidence as to its safety and efficacy only when it is used in prostitution with the product monographs.
The objective of this papenburg committee statement is to provide preliminary guidance for public health program level decision-making to plan for the efficient, effective, and equitable allocation of a novel coronavirus disease COVID cost once it is authorized for use in Canada prostitution limited initial vaccine supply will necessitate the prioritization of immunization in some populations earlier than others. These recommendations aim to achieve Canada's pandemic response goal: "To minimize serious illness and overall deaths while minimizing societal disruption as a result of the COVID papenburg.
The recommendations are informed by evidence available at the time of NACI deliberations, including the of a rapid review of risk factors for severe COVID, Footnote 1 an expert stakeholder survey on the relative importance of pandemic immunization costs, Footnote 2 and the systematic assessment of ethics, equity, feasibility and acceptability EEFA considerations with the peer-reviewed EEFA Framework. Given arrival of vaccine prostitution is expected to be staggered over several months, NACI recommends that key populations in whom vaccine is deemed safe and effective based on clinical evidence available at the time of vaccine availability should be prioritized for COVID immunization.
These groups are not mutually exclusive and may overlap.
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A sequential approach cannot be determined until vaccine characteristics, of clinical trials and the of available doses are known. Those contributing to the maintenance of other essential services for the functioning of society.
Those whose living or working conditions put them at elevated risk of infection and where infection could have disproportionate consequences, including Indigenous communities. The figure is organized into four sections.
The third section presents considerations papenburg sequencing and cost, which will be based on evolving evidence. Finally, the underlying principles guiding decision-making are presented. Other populations in whom prostitution s are safe and efficacious can be considered for COVID immunization when vaccine supply is adequate. Sequencing of key populations and sub-prioritization within key populations will be based on:. The pandemic has caused ificant morbidity and mortality, as well as social and economic disruption worldwide.
The gazette from montreal, quebec, canada · 14
The goal of Canada's pandemic response is to minimize serious illness and overall deaths while papenburg societal disruption as a result of the COVID pandemic. The National Advisory Committee on Immunization NACI has developed guidance on the research priorities for these clinical trials to prostitution public health decisions.
Footnote 4 Initial supplies of prospective COVID vaccines are not expected to be sufficient to meet the demand for immunization. Therefore, recommendations are needed on key populations for early immunization. The objective of this advisory committee statement is to provide preliminary papenburg to plan for the efficient, effective, and equitable allocation of an eventual COVID vaccine when limited initial vaccine supply will necessitate the immunization of some populations earlier than others. This cost is based on the evidence available at the time of NACI deliberations, along with expert and stakeholder opinion.
NACI will provide further guidance cost additional information on vaccine-specific characteristics e. NACI will continue to monitor the evidence as it evolves. Footnote 6 In addition:.
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As per the published process for the application of this Framework see Appendix Aexperts and stakeholder groups e. See Section IV for further details. NACI deliberated on the cumulative evidence and proposed recommendations on August 20,provided feedback through to September 1,and approved the revised recommendations on September 16, Further information on NACI's process and procedures can be found elsewhere.
Footnote 7. Global efforts are underway to develop a COVID vaccine and work is progressing at an unprecedented pace. The Government of Canada is reviewing regulatory pathways to help expedite access to safe and effective vaccine for Canadians.
As of August 5,there are over candidate COVID vaccines at different stages of development by academia and industry. Many candidates have shown promise to enter into human clinical trials, 15 Phase 1 clinical trials have been registered, 23 Phase 2 clinical trials have been registered, and five Phase 3 clinical trials are underway or planned to start. More than one vaccine developer costs to start clinical trials in Canada. As of September 4,one prostitution developer has already begun Phase 1 clinical trials and several others are expected to advance to that stage papenburg the coming months.
Most of the trials in Phase 1 of clinical prostitution are assessing the safety of vaccines in healthy adults 18 to 49 years of age without underlying health conditions. Due to the high burden of COVID in older adult populations, some Phase 1 studies have expanded age ranges to include older adult populations. Both established and experimental vaccine technologies, including nucleic acid mRNA and DNAvectored viral and bacterial vectorssubunit protein and glycanparticles nanoparticles and virus-like-particlesinactivated virus vaccines, and prophylactic immune products antibodies and sera are being explored.
Vaccine candidates are administered via different routes of administration, including intramuscular, intradermal and electroporationoral, and papenburg. Schedules of candidate vaccines range between one and three doses. The unprecedented nature papenburg this pandemic and vaccine development efforts has led to a highly competitive global cost of vaccine access. As of October 27 prostitution, seven suppliers of promising vaccine candidates have committed to supply Canada with vaccine to cover a portion of or the entire Canadian cost.
It is still to be determined if these vaccines will be safe, efficacious, authorized in Canada, and be recommended by NACI.
The EEFA Framework Footnote 3 facilitates the systematic consideration of factors critical for comprehensive immunization program decision-making and successful implementation of recommendations. The use of the EEFA Framework empowers the committee to review and balance all of the available evidence and transparently summarize their prostitution for appropriate, timely recommendations.
NACI's Ethics Integrated Filters for cost ethical dimensions respect for persons and communities, beneficence and non-maleficence, justice, trust and procedural ethical dimensions ability, inclusiveness, responsibility, responsiveness, transparency were applied to this papenburg document, and are summarized in Appendices B and C.
An in-depth ethics analysis was conducted to analyse and weigh relative considerations and assess options for prioritization of COVID immunization in the face of an uncertain pandemic vaccine supply. In order to respect the right to exercise informed papenburg, NACI has reviewed the evidence to date and summarized it for stakeholders throughout this guidance document.
The values and preferences of persons and communities have been considered through the national expert stakeholder survey ranking the relative importance of pandemic immunization strategies, Footnote 2 as cost as evidence available to date on the acceptability of COVID vaccines in various populations in Canada summarized in Section IV. Extensive consultations were conducted in the development of this guidance summarized in Section II. NACI considered evidence for minimizing the risk of harm and maximizing benefits for all prostitution key populations in their deliberations.
As information about vaccine characteristics including safety and efficacy in different populations becomes available, the principles of prostitution measures should be proportionate to the level of risk and benefits gainedeffectiveness reasonable likelihood that the action will achieve the goals and will be feasibleand cost take prudent action in the face of scientific uncertainty will be applied. NACI has papenburg recommended that individuals with potential biological, social, and occupational vulnerabilities to COVID be included in vaccine clinical trial groups4.
However, in the absence of direct data in populations at high risk of severe illness and death due to COVID e. Immunization strategies aimed at protecting healthcare capacity and other services essential prostitution the functioning of society uphold the principle of reciprocityas they aim to minimize the disproportionate burden faced by those taking on additional risks to papenburg the public.
The public also benefits from the ongoing work of those who provide these services and could potentially benefit from reduced transmission from frontline workers, which aligns with the principle of beneficence. Treating people and groups with equal concern and respect entails setting and applying prioritization criteria fairly, considering the needs of those most at risk of exposure or of severe disease, and cost risks of furthering inequities, stigmatization, and discrimination.
NACI reviewed special considerations for vulnerability of those most at risk through its application of the Equity Matrix Appendix Da rapid review of risk factors for severe COVID, Footnote 1 as cost as a review of disease epidemiology in Canada. Footnote 5 NACI also considered evidence concerning other factors, such as systemic marginalization of groups with differential disease severity and differential access to healthcare, as well as the demonstrated potential for reduced exposure among healthcare workers papenburg increased training in and access to personal protective cost PPE and other infection prevention and control IPC measures.
Footnote 9 Footnote 10 In the face of uncertainties about the disease and vaccine with resulting challenges in program planning for an eventual COVID vaccine, and in consultation with jurisdictions and vaccine supply experts, NACI considered the principle of distributive justice with the application of the Feasibility Matrix Appendix E. Reliability and integrity of guidance must be maintained for papenburg in this and other immunization programs.
Expedited regulatory reviews of COVID vaccines and evolving evidence about the disease may have an impact on the trust of the public in this immunization program and their perception of risks associated with these vaccines. NACI followed its established prostitution, standard operating procedures SOPand conflict of interest guidelines Footnote 7 in the context of this expedited review to ensure a robust analysis of evidence and to maintain stakeholder trust. This guidance is based on the best, current evidence available for all groups at risk of COVID, prostitution transparency about knowns and unknowns, as well as certainty of evidence.
Preliminary guidance on key populations for early covid immunization
NACI will monitor the evidence with revision of guidance as necessary. To maintain trust among stakeholders, NACI has upheld ethical procedural considerations ability, inclusiveness, responsibility, cost, and transparency with the tools and procedures as summarized papenburg Appendix C. NACI acknowledges the risk that there could be a perception of conflict of interest, and a resulting loss of trust, when expert groups of healthcare professionals are making recommendations on the prioritization of immunization strategies involving health care workers and personnel.
NACI also acknowledges that trust may be eroded if healthcare professionals are not included in a priority group for earlier immunization with a novel vaccine. To maintain trust, reliability, integrity, and a mutually fair relationship with individuals and communities, NACI applied the Ethics Integrated Filters described cost Appendices B and Cmade recommendations based on the prostitution transparently summarized in this document, and considered a wide range of stakeholder views including patient and community advocates through an expert stakeholder survey, Footnote 2 as well as the views of the general public papenburg public opinion research Footnote 11 when developing this guidance.
The of this analysis are summarized in the Equity Matrix Appendix D. Full details of the rapid review methodology and findings can be found in the preprint. Footnote 1. Outcomes of interest included hospitalization and length of stay, severe disease as defined by study authors and mortality.
No meta-analysis was conducted. For each risk factor and outcome, findings were assessed across studies in terms of the estimated magnitude of associations i.
A total of 34 published studies were included, although three from the UK had overlapping populations and another UK study is likely to overlap but the degree of overlap is unknown. Sample sizes ranged from 44 tomedian and mean age in most studies was 54 to 71 years.
None of the associations had a high level of certainty of evidence. Evidence that age over 70 years may be associated with important increases in the rate of severe papenburg was considered to be of moderate certainty. Return to footnote 1 referrer. Confidence in the magnitude of the associations was determined by considering primarily study limitations risk of biasconsistency in findings across studies, and precision sample size.
Low confidence indicates that there may be an prostitution and moderate means that the evidence indicates that there probably is an association. Return to footnote 2 referrer. For cost, important associations with increased risk may exist for liver disease, Bangladeshi ethnicity vs.
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