PROGRESS: A Patient-centered Engagement Infrastructure and Multi-level Approach to Enrich Diversity, Equity, and Inclusion in a National Randomized Online Behavioral Pain Treatment Study.

Twenty percent of individuals experience chronic pain worldwide posing significant challenges to those living with it. Pain research is crucial for developing and characterizing effective strategies to reduce the burden of chronic pain. Traditional research approaches often yield homogeneous study samples that poorly generalize and have unknown applicability across diverse patient populations. The Pain Relief with Online Groups that Empower Skills-based Symptom Reduction (PROGRESS) study aims to address disparities in pain research engagement and patient outcomes through the intentional inclusion of people with varied backgrounds and experiences of pain, and through a multilevel design informed by diverse stakeholder recommendations. The composition of three advisory boards (Patient Engagement and Diversity Board, Local Patient Advisory Board, and the National Patient Advisory Panel) prioritized diversity in patient/expert advisor background, geographic location, race, and ethnicity. Our engagement approach aligns with the Foundational Expectations for Partnerships in Research by Patient-Centered Outcomes Research Institute (PCORI), which emphasizes diverse representation, early and ongoing engagement, dedicated funds for advisor compensation, collaborative decision making, meaningful participation, and continuous assessment. The first 24 months of study advisor engagement has yielded multiple recruitment strategies resulting in a study population enriched with a breadth of identities within PROGRESS (e.g., inclusive patient-facing materials). Lessons learned underscore the importance of investing time in building patient and stakeholder relationships, trust, and embracing diverse viewpoints amongst the study team. PROGRESS demonstrates the potential of diverse patient-centered engagement to support evidence-based outcomes and practices that are more inclusive, equitable, and representative of the broader population. PERSPECTIVE: The PROGRESS study demonstrates how diverse patient engagement and inclusive advisory boards enhance research outcomes. By aligning with PCORI standards and employing innovative recruitment strategies, it highlights the vital role of stakeholder relationships and diverse perspectives. Key lessons learned emphasize adaptive strategies and continuous feedback for advancing equitable pain research.

Of rats and children: plague, malaria, and the early history of disease reservoirs (1898-1930).

This article's jumping-off point is the highly incisive but often-ignored claim by the French doctor, Louis-Jacques Tanon, in 1922 that rats acted as plague reservoirs in Paris; in other words, that they harboured the plague bacillus but were refractory to it. This claim partially reframed the fight against this disease in the French capital in the 1920s, which became more centred on surveilling the plague reservoir rather than on destroying rats. Drawing upon Tanon's hypothesis, this article explores the emergence, evolution, and several iterations of the idea of disease reservoirs in the early twentieth century. On the one hand, it describes the crafting of a range of ideas with which Tanon was directly or indirectly dialoguing, namely, that rats could present a stage called chronic plague, which was especially developed in India; and that human populations, especially children, acted as sources or reservoirs of malaria in Sierra Leone and Algeria. On the other hand, this article shows how Tanon created original reasoning by combining and reformulating some of these ideas and applying them to Paris. Thus, this article contributes to the early history of reasoning in terms of disease reservoirs, as well as presenting a more dynamic history of microbiology by showing how concepts crafted in the "Rest" found their place in Europe.

Reflections on the Advisory Committee on Immunization Practices During the COVID-19 Pandemic.

Pediatricians and primary care providers serve an important role in building trust with families and communities. To support the critical role of front-line providers, this perspective seeks to reflect on the work of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices to support COVID-19 pandemic response efforts. Although Advisory Committee on Immunization Practice (ACIP) recommends vaccines for all age groups, this perspective focuses on the pediatric lens and is tailored to Academic Pediatrics. ACIP adapted from in-person meetings 3 times yearly to virtual meetings on an emergency basis to ensure a thorough review and presentation of all the components of the evidence to recommendation framework, including explicit consideration of equity in the decision-making process. The need for diverse enrollment in clinical trials was highlighted as critical for supporting recommendations and enhancing trust. Near real-time vaccine safety surveillance was implemented at scale and emphasized the importance of collaboration between federal partners engaged in vaccine safety in the United States and extended to other countries with similar safety surveillance systems to enable early recognition and response to safety concerns. A key equity opportunity for future pandemics is to shorten the time between vaccines being available for adults and young children.

Knowledge, Attitudes, and Practices Regarding Herpes Zoster Vaccination Among Specialists.

Recombinant zoster vaccine has been recommended by the US Advisory Committee on Immunization Practices (ACIP) for the prevention of herpes zoster (HZ) in immunocompetent adults aged at least 50 years since 2018. In January 2022, this was extended to immunodeficient/immunosuppressed adults aged at least 19 years. Key study objectives were to assess specialists' knowledge of the ACIP HZ vaccination recommendations, their attitudes toward HZ vaccination, and HZ vaccination practices/barriers. This cross-sectional, web-based survey (conducted in March 2022) included US dermatologists, gastroenterologists, infectious disease specialists, oncologists, and rheumatologists who treat patients with psoriasis, inflammatory bowel disease, human immunodeficiency syndrome, solid tumors/hematological malignancies, and rheumatoid arthritis, respectively. Although most of the 613 specialists correctly identified the ACIP HZ vaccination recommendations for adults aged at least 50 years (84%) and immunodeficient/immunosuppressed adults aged at least 19 years (67%), only 29% knew that recombinant zoster vaccine is recommended for individuals who have previously received zoster vaccine live, and only 18% knew all current ACIP recommendations. For patients with the diseases listed, 84% of specialists thought that HZ is a serious risk, 75% that HZ vaccination is extremely/very important, and 69% were extremely/very likely to recommend HZ vaccination. Only 36% administer vaccines themselves, mainly because patients receive vaccinations from others. Barriers to vaccination included more urgent/acute issues, insufficient time, and lack of patient motivation/willingness. Full knowledge of the ACIP HZ vaccination recommendations among the surveyed specialists was low. There may be a need to educate specialists to improve adherence to these recommendations. [Figure: see text].

Summary of the National Advisory Committee on Immunization (NACI) Updated Guidance on Influenza Vaccination During Pregnancy.

Background: Seasonal influenza infection can lead to serious complications and adverse outcomes for pregnant individuals, the developing fetus and infants younger than six months of age. This supplemental statement provides an evidence summary on the safety and effectiveness of influenza vaccination in pregnant individuals, and the benefits and risks to the pregnant person, the developing fetus and infants younger than six months of age. Methods: A systematic review was conducted on the effectiveness and safety of influenza vaccination in pregnancy. The National Advisory Committee on Immunization (NACI)'s evidence-based process was used to assess the quality of eligible studies, summarize and analyze the findings, and apply an ethics, equity, feasibility and acceptability lens to develop recommendations. Results: The evidence suggests that influenza vaccination during pregnancy is effective in reducing the risk of laboratory-confirmed influenza infection and hospitalization in both pregnant individuals and their infants up to six months postpartum. The evidence also suggests that influenza vaccination during pregnancy does not increase the risk of non-obstetric serious adverse events in pregnant persons, infant death, spontaneous abortion, stillbirth, preterm birth, small for gestational age, low birth weight and congenital anomalies. Conclusion: Based on this body of evidence, NACI reaffirms the safety and importance of influenza vaccination during pregnancy. NACI recommends that individuals at any stage of pregnancy should receive an age-appropriate inactivated, unadjuvanted or recombinant influenza vaccine each influenza season. Influenza vaccination may be given at the same time as, or at any time before or after administration of another vaccine, including the coronavirus disease 2019 (COVID-19) or pertussis vaccines.

Addressing misinformation about the Dietary Guidelines for Americans.

The Dietary Guidelines for Americans (DGA) provides science-based advice on dietary intake to promote health, reduce risk of chronic disease, and meet nutrient needs. It is jointly published by the United States Departments of Health and Human Services and Agriculture (USDA) every 5 y. As chronic diseases continue to rise to pervasive levels, helping the United States population follow the DGA is especially important for improving the health of our nation. The DGA is developed using a rigorous and transparent scientific process, and with the advice of an independent, external committee of leading scientists. Career federal nutrition scientists who manage the process ensure that the methods used to develop the DGA remain state of the art. Unfortunately, misinformation about the scientific basis, transparency, and relevance of the DGA for the United States population threatens its credibility. The main objective of this article is to correct this misinformation with factual information about the process used to develop the DGA. The DGA provides guidelines for the general public, and its primary audience includes policymakers and nutrition and health professionals who help individuals and families consume a healthy dietary pattern. Providing accurate information may bolster trust in the recommendations among these audiences while improving implementation across sectors to promote better adherence to the DGA, thereby improving diet quality among the United States population.

Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA).

BACKGROUND: Involving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. METHODS: A SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project's duration. RESULTS: The SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients. CONCLUSIONS: Our study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

Clinical research should involve patient and community stakeholder perspectives to make sure the study addresses questions important to the studied population. One way to do this is by creating a group of stakeholders who can advise on the conduct of a study. We assembled a Study Advisory Committee (SAC) for the Emergency Medicine Palliative Care Access (EMPallA) trial. The purpose of this clinical trial is to compare the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness. This paper describes how the SACs involvement translated into direct impacts on the EMPallA trial. The trial research team held regular meetings with the SAC throughout the trial process. Their involvement led to many significant changes in the trial, such as  expanding recruitment inclusion criteria (Spanish-speaking patients), and including survey instruments to measure lonelines and caregiver burden. The SAC also devised strategies to overcome patient and caregiver recruitment and retention challenges, including the creation of patient-friendly materials and training for research coordinators. This study provides a successful example of how actively engaging patient and community stakeholders, through committee engagement, can promote patient priorities in all phases of a trial while facilitating patient recruitment and retention.

What's in This For You? What's in This For Me?: A Win-Win Perspective of Involving Study Advisory Committee Members in Palliative Care Research.

Study advisory committees (SACs) provide critical value to clinical trials by providing unique perspectives that pull from personal and professional experiences related to the trial's healthcare topic. The Emergency Medicine Palliative Care Access (EMPallA) study had the privilege of convening a 16-person SAC from the project's inception to completion. The study team wanted to understand the impact this project had on the SAC members. In this narrative, we use reflective dialogue to share SAC members' lived experiences and the impact the EMPallA study has had on members both personally and professionally. We detail the (1) benefits SAC members, specifically patients, and caregivers, have had through working on this project. (2) The importance of recruiting diverse SAC members with different lived experiences and leveraging their feedback in clinical research. (3) Value of community capacity building to ensure the common vision of the clinical trial is promoted.

Developing food-based dietary recommendations in the UK.

The present paper provides an overview of the approach to developing food-based dietary recommendations in the UK. UK dietary recommendations are based on independent advice from the Scientific Advisory Committee on Nutrition (SACN). SACN's remit includes specific reference to the nutrient content of individual foods and advice on diet as a whole, including the definition of a balanced diet. SACN's approach is set out in its Framework for Evaluating Evidence and its assessments are supported by the data provided by the National Diet and Nutrition Survey. SACN's risk assessments have primarily focused on energy requirements, macro and micronutrients and/or the needs of specific population groups. However, dietary patterns or individual foods and health outcomes have been considered where sufficient evidence is available. An example of this is SACN's risk assessment on carbohydrates and health, which included consideration of evidence on sugar-sweetened beverages and the resulting dietary recommendations on free sugars and sugar-sweetened beverages led to a range of policies to reduce sugar intake in the UK, including the soft drinks industry levy. SACN has also recently published a position statement on processed foods and health. Government dietary advice is encapsulated in the UK's national food model, the Eatwell Guide. The Eatwell Guide shows the proportions in which different food groups should be consumed to have a well-balanced, healthier, more sustainable diet, to help meet nutrient requirements and reduce the risk of chronic disease. Any substantive change to government dietary advice is likely to lead to a review of the national food model.

Accidents and injuries related to paragliding on mount Babadag, Turkey: A cross-sectional study.

OBJECTIVES: In light of the growing popularity of paragliding, this cross-sectional study aimed to investigate the epidemiology of paragliding accidents, providing insights into the types and severity of injuries sustained as well as the body regions most commonly affected. METHODS: This cross-sectional retrospective study utilized data on adverse paragliding events on Mount Babadag in Turkey, collected by the Mugla Sports Tourism Board (STB) between January 2020 and December 2021, with data sources including out-of-hospital STB forms and in-hospital electronic health records. RESULTS: Out of 241,420 paragliding flights, a total of 44 accidents were identified, with only three resulting in fatalities. Most of the accidents occurred during take off and landing, but the deadliest phase was during flight. The majority of accidents were of low severity, with a median National Advisory Committee for Aeronautics score of 1 (interquartile range [IQR] 1-3) and a median injury severity score of 1 (IQR 1-7.75). The lower limb was the most commonly injured body part, accounting for 55.8% of injuries, followed by the upper limb at 30.8%. CONCLUSIONS: Despite being considered an extreme sport, paragliding carries a relatively low risk of accidents and serious injuries, owing to advancements in training, equipment inspection, and protective gear.

Canada's National Advisory Committee on immunization: Adaptations and challenges during the COVID-19 pandemic.

The COVID-19 pandemic has challenged traditional vaccine guidance infrastructure and frameworks, and added urgency and complexity to the operation of National Immunization Technical Advisory Groups (NITAGs). Canada's National Advisory Committee on Immunization (NACI) provides immunization guidance to the Public Health Agency of Canada (PHAC) who publicly shares expert and evidence-informed guidance with Canadian provinces and territories. Throughout the pandemic, NACI and PHAC implemented many adaptations to meet urgent needs for pandemic vaccine guidance. In this paper, we describe: structural adaptations in response to the accelerated pace and amount of work required to issue recommendations that were timed around product authorizations and dynamic epidemiology; technical adaptations in response to rapidly evolving evidence of variable quality which required close monitoring, and which promoted reliance on basic vaccine principles due to incomplete direct evidence; the need to provide nimble advice (e.g., off-label recommendations, preferential recommendations); communications adaptations (e.g. identify sustainable spokespeople for the committee, receive stakeholder feedback, and ensure urgent nuanced advice was communicated to a diverse audience); and research adaptations focussing on solutions to constrained supply (e.g. prioritisation, extended intervals, and heterologous schedules). The early pandemic vaccine experience has created a roadmap of lessons and adaptations that should be leveraged in future pandemic vaccine programs, and has highlighted the essential role of NITAGs to complement regulatory structures during pandemics to ensure timely, impactful, and evidence-informed public health vaccine guidance.

Immunization, not vaccination: monoclonal antibodies for infant RSV prevention and the US vaccines for children program.

In the US, RSV imposes significant burdens on infants, households, and the health system. Yet the only licensed immunization is accessible to only certain risk groups comprising 2% of the infant population, leaving the remaining 98% unprotected. An effective immunization for all infants is a significant public health priority. One possible solution is the FDA-approved monoclonal antibody nirsevimab, which recent evidence suggests is safe and effective in preventing RSV in all infants, and which is currently being considered for inclusion in the pediatric immunization schedule and the federal Vaccines for Children (VFC) program. But the question arises whether passive immunization products like nirsevimab ought to be eligible for the VFC, which nominally and traditionally centers on vaccines providing active immunity. Addressing this is urgent because VFC inclusion will be decided on imminently. I argue there are strong policy grounds, i.e., reasons grounded in the ultimate health system goals of maximizing population health or social welfare subject to resource constraints, not to exclude passive immunization from VFC eligibility. Active and passive immunizations both provide adaptive immunity and can therefore produce qualitatively similar effects on risks of infection, disease, and transmission; on disease severity and duration; and on health, welfare, and health resource use. The distinction between active and passive immunization does not intrinsically matter since what matters for the attainment of health system goals is the extent of immunity conferred, not whether immunity is active or passive. Nor can passivity be considered a useful proxy for conferring a lesser extent of immunity, since no such proxy is needed (existing valuation methods can cope with variations in product attributes), and it is a poor proxy (passive immunizations can be better for individuals with impaired immune systems and can have comparable effectiveness durations and economic value as vaccines).

Coordinating science during an eruption: lessons from the 2020-2021 Kilauea volcanic eruption.

Data collected during well-observed eruptions can lead to dramatic increases in our understanding of volcanic processes. However, the necessary prioritization of public safety and hazard mitigation during a crisis means that scientific opportunities may be sacrificed. Thus, maximizing the scientific gains from eruptions requires improved planning and coordinating science activities among governmental organizations and academia before and during volcanic eruptions. One tool to facilitate this coordination is a Scientific Advisory Committee (SAC). In the USA, the Community Network for Volcanic Eruption Response (CONVERSE) has been developing and testing this concept during workshops and scenario-based activities. The December 2020 eruption of Kilauea volcano, Hawaii, provided an opportunity to test and refine this model in real-time and in a real-world setting. We present here the working model of a SAC developed during this eruption. Successes of the Kilauea SAC (K-SAC) included broadening the pool of scientists involved in eruption response and developing and codifying procedures that may form the basis of operation for future SACs. Challenges encountered by the K-SAC included a process of review and facilitation of research proposals that was too slow to include outside participation in the early parts of the eruption and a decision process that fell on a small number of individuals at the responding volcano observatory. Possible ways to address these challenges include (1) supporting community-building activities between eruptions that make connections among scientists within and outside formal observatories, (2) identifying key science questions and pre-planning science activities, which would facilitate more rapid implementation across a broader scientific group, and (3) continued dialog among observatory scientists, emergency responders, and non-observatory scientists about the role of SACs. The SAC model holds promise to become an integral part of future efforts, leading in the short and longer term to more effective hazard response and greater scientific discovery and understanding.

Perspective: Examining Conflicts of Interest for Professional Service within the 2020 Dietary Guidelines Advisory Committee.

Judgments and integrity uphold professionalism. Failure to manage professional conflicts of interest (COIs) may undermine trust in an individual, practitioner, or institution. This perspective article examines standards for nutrition researchers and practitioners to manage COIs for the Dietary Guidelines for Americans (DGA) process. Thereafter, this article analyzes a study published by Mialon et al. that raised concerns about the expert advisory committee selection process and management of COIs for 20 professionals appointed by the Department of Health and Human Services (HHS) and the USDA, who served on a federal government advisory committee to review evidence for the Dietary Guidelines Advisory Committee (DGAC) 2020 scientific report. The analysis found that Mialon et al. enumerated COIs for each DGAC member with industry, removed from the original context, which prevented readers from assessing the COI risk. Moreover, the USDA ethics office concluded that "the 20 committee members were in full compliance with the federal ethics rules applicable to special government employees." I conclude that Mialon et al. could use institutional mechanisms to encourage the USDA and HHS to strengthen future COI policies and procedures, aligned with the 2022 National Academies of Sciences, Engineering and Medicine report recommendations to improve the DGA 2025 to 2030 process.

Safety of measles, mumps, and rubella vaccine in adolescents and adults in the vaccine safety Datalink.

Background: Measles, mumps, and rubella vaccine (MMR) is routinely administered to children; however, adolescents and adults may receive MMR for various reasons. Safety studies in adolescents and adults are limited. We report on safety of MMR in this age group in the Vaccine Safety Datalink. Methods: We included adolescents (aged 9-17 years) and adults (aged ≥ 18 years) who received ≥ 1 dose of MMR from January 1, 2010-December 31, 2018. Pre-specified outcomes were identified by diagnosis codes. Clinically serious outcomes included anaphylaxis, encephalitis/myelitis, Guillain-Barré syndrome, immune thrombocytopenia, meningitis, and seizure. Non-serious outcomes were allergic reaction, arthropathy, fever, injection site reaction, lymphadenopathy, non-specific reaction, parotitis, rash, and syncope. All serious outcomes underwent medical record review. Outcome-specific incidence was calculated in pre-defined post-vaccination windows. A self-controlled risk interval design was used to determine the relative risk of each outcome in a risk window after vaccination compared to a more distal control window. Results: During the study period, 276,327 MMR doses were administered to adolescents and adults. Mean age of vaccinees was 34.8 years; 65.8 % were female; 53.2 % of doses were administered simultaneously with ≥ 1 other vaccine. Serious outcomes were rare, with incidence ≤ 6 per 100,000 doses for each outcome assessed, and none had a significant elevation in incidence during the risk window compared to the control window. Incidence of non-serious outcomes per 100,000 doses ranged from 3.4 for parotitis to 263.0 for arthropathy. Other common outcomes included injection site reaction and rash (157.0 and 112.9 per 100,000 doses, respectively). Significantly more outcomes were observed during the risk window compared to the control window for all non-serious outcomes except parotitis. Some variability was observed by sex and age group. Conclusion: Serious outcomes after MMR are rare in adolescents and adults, but vaccinees should be counseled regarding anticipated local and systemic non-serious adverse events.

The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia.

OBJECTIVE: To review the sequence of events that led to the Therapeutic Goods Administration (TGA) approval of esketamine in Australia, and to explore the potential ethical and clinical consequences of it. CONCLUSIONS: Trust in the TGA is of paramount importance to Australian psychiatrists. The approval of esketamine raises serious questions about the processes, independence and authority of the TGA, and therefore the confidence Australian psychiatrists can have in the 'quality, safety and efficacy' of the drugs they offer their patients.

Summary of the National Advisory Committee on Immunization (NACI) Statement-Recommendation on Repeated Seasonal Influenza Vaccination.

Background: Influenza vaccination is recommended annually; however, some studies have raised questions regarding whether repeated influenza vaccine administration may have unintended negative consequences for seasonal protection. Methods: The National Advisory Committee on Immunization (NACI) Influenza Working Group undertook an overview of systematic reviews on the effects of repeated influenza vaccination on vaccine effectiveness, efficacy, and immunogenicity. A systematic assessment of programmatic factors was conducted according to established NACI methods. The NACI evidence-based process was used to critically appraise the available evidence and to review recommendations. Results: The evidence base consisted of four eligible systematic reviews/meta-analyses. Repeated vaccination, including the current season, was consistently more effective than no vaccination in the current season. The evidence showed no significant difference or predictable trend in vaccine efficacy or effectiveness between vaccinations in two consecutive seasons compared to vaccination in the current season only. Conclusion: Overall, NACI concluded that there is evidence to recommend annual influenza vaccination, irrespective of whether an individual received the seasonal influenza vaccine in previous seasons. It is neither currently feasible nor warranted to modify existing annual influenza vaccination programs to account for potential negative or positive interference. NACI continues to strongly recommend that seasonal influenza vaccine should be offered annually to everyone six months of age and older who does not have contraindications to the vaccine, irrespective of previous seasons' influenza vaccination status.

Summary of the National Advisory Committee on Immunization (NACI) Statement-Recommendations on Fractional Influenza Vaccine Dosing in the Event of a Shortage: Pandemic preparedness.

Background: At the commencement of a pandemic, it is important to consider the impact of respiratory infections on the health system and the possibility of vaccine shortages due to increased demand. In the event of an influenza vaccine shortage, a strategy for administration of fractional influenza vaccine doses might be considered. This article reviews the available evidence for efficacy, effectiveness, immunogenicity and safety of fractional influenza vaccine dosing, and summarizes the National Advisory Committee on Immunization (NACI) recommendations on fractional dosing strategies by public health programs in Canada. Methods: Two rapid literature reviews were undertaken to evaluate the efficacy, effectiveness, immunogenicity and safety of fractional influenza vaccine dosing via the intramuscular or intradermal route. The NACI evidence-based process was used to assess the quality of eligible studies, summarize and analyze the findings, and apply an ethics, equity, feasibility and acceptability lens to develop recommendations. Results: There was limited evidence for the effectiveness of fractional influenza vaccine dosing. Fractional dosing studies were primarily conducted in healthy individuals, mainly young children and infants, with no underlying chronic conditions. There was fair evidence for immunogenicity and safety. Feasibility issues were identified with intradermal use in particular. Conclusion: NACI recommended that, in the event of a significant population-level shortage of influenza vaccine, a full-dose influenza vaccine should continue to be used, and existing vaccine supply should be prioritized for those considered to be at high risk or capable of transmitting to those at high risk of influenza-related complications or hospitalizations. NACI recommended against the use of fractional doses of influenza vaccine in any population.

A National Advisory Committee on Immunization (NACI) update on invasive meningococcal disease (IMD) epidemiology and program-relevant considerations for preventing IMD in individuals at high risk of exposure.

Following recent outbreaks of invasive meningococcal disease (IMD) in Canada and updates to provincial vaccination guidelines, the National Advisory Committee on Immunization (NACI) conducted a targeted review of evidence with a focus on immunization of adolescents and young adults. NACI reviewed national and international immunization recommendations for populations at high-risk of IMD, national IMD epidemiology and program-relevant considerations. Given the varied IMD epidemiology, NACI determined that recommending a pan-Canadian targeted program is currently challenging and that regional programs may be better suited to prevent IMD in population groups considered to be at high-risk of exposure. Further data is needed to ascertain contemporary risk factors for IMD (including activities and settings associated with bacterial acquisition, carriage and transmission) and estimate the true cost of meningococcal vaccine-preventable infections in Canada. To support provinces and territories in their decision-making, an outline of program-relevant elements for provincial and territorial consideration is provided.

Summary of the National Advisory Committee on Immunization (NACI) Seasonal Influenza Vaccine Statement for 2023-2024.

Background: The National Advisory Committee on Immunization (NACI) reviews the evolving evidence on influenza immunization and provides annual recommendations regarding the use of seasonal influenza vaccines. The NACI Statement on Seasonal Influenza Vaccine for 2023-2024 updates the 2022-2023 NACI recommendations. Objective: To summarize the 2023-2024 NACI seasonal influenza vaccine recommendations and to highlight new and updated information. Methods: In the preparation of the Statement on Seasonal Influenza Vaccine for 2023-2024, the NACI Influenza Working Group applied the NACI evidence-based process to critically appraise the available evidence and to propose recommendations. The recommendations were then considered and approved by NACI in light of the available evidence. Results: Key changes for the 2023-2024 season include: 1) incorporation of updated information/guidance on influenza vaccination in the context of the coronavirus disease 2019 (COVID-19); 2) new recommendations for Flucelvax® Quad and Influvac® Tetra, the two quadrivalent inactivated influenza vaccines with expanded paediatric age indications; and 3) an update to the format of the Statement. Conclusion: Overall, NACI continues to recommend that an age-appropriate influenza vaccine should be offered annually to all individuals aged six months and older who do not have a contraindication to the vaccine, with particular focus on the groups for whom influenza vaccination is particularly recommended.