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Overdiagnosis of anaphylaxis risk is an underappreciated aspect of anaphylaxis prevention. Whereas the benefits of anaphylaxis-risk prevention are well known, potential harms resulting from preemptive approaches to mitigate anaphylaxis-risk are not insignificant. Still, great progress has been made in recent years to avoid the unintended consequences of anaphylaxis-risk overdiagnosis. Reflection on recent advances in the use of diagnostic testing, as well as the application of diagnostic labels, provides an important perspective to understand how far the specialty of allergy and immunology has come in improving the lives of patients and families. Examples of recent paradigm shifts in anaphylaxis-risk management include approaches to peanut allergy prevention without screening, deferral of corticosteroids to prevent biphasic anaphylaxis reactions, reevaluation of reflex use of emergency medical services for resolved community anaphylaxis, and an approach to penicillin allergy delabeling with direct oral challenge. Routine medical practices to decrease anaphylaxis risk can have lifelong impacts for patients-beyond just preventing anaphylaxis. As our understanding of these trade-offs evolves, it becomes necessary to weigh both the benefits and the harms of past management approaches. Because medicine remains a science of uncertainty and an art of probability, a critical approach to risk mitigation remains necessary to find the often-elusive balance in anaphylaxis prevention.

Background The Food Allergy Quality-of-Life Questionnaire-Parent Form (FAQLQ-PF) is widely used to assess food allergy-specific health-related quality of life (FAQL), but cannot be used directly in cost-utility analyses, which require health state utility (HSU) scores. Currently, limited evidence is available regarding the HSU of food-allergic children/adolescents. This study aimed to develop mapping algorithms from the FAQLQ-PF onto HSU scores generated by generic, preference-based, health-related quality-of-life (HRQL) instruments. Methods Caregivers of children aged 7 to 17 years with a clinician diagnosis of IgE-mediated food allergy, recruited via Allergy & Anaphylaxis Australia, completed an online FAQLQ-PF questionnaire and proxy generic preference-based pediatric instruments (Assessment of Quality of Life [AQoL]-6D and Child Health Utility 9D [CHU9D]). Optimal statistical methods were based on series of goodness-of-fit statistics. Results Mean FAQLQ-PF total score, AQoL-6D, and CHU9D utility scores of 238 food-allergic children/adolescents were 3.49 (SD: 1.41), 0.78 (SD: 0.22), and 0.74 (SD: 0.22), respectively. The Spearman correlation coefficients of FAQLQ-PF with AQoL-6D and CHU9D were rho = -0.56 and rho = -0.45, respectively. Optimal mapping algorithms were generated from selected FAQLQ-PF items, mapped onto AQoL-6D or CHU9D utility scores, with AQoL-6D demonstrating better performance. Conclusions This study generated mapping algorithms to help facilitate the use of FAQLQ-PF for cost-utility analyses, which are essential for health economic evaluation. External validation of the reported mapping algorithms is warranted.

In the face of tremendous uncertainty during the current pandemic, there is a need for clear and consistent recommendations and an understanding of the evidence in general, and for families of children with allergic conditions. A common concern of parents of children with asthma is the risk that in-person learning poses during the pandemic. This Rostrum examines the actual risk of in-person learning among children with asthma during novel coronavirus disease 2019 (COVID-19), the discrepancy between perceived and actual risk, the contributing factors to this discrepancy, and possible solutions to narrow this divide. Overall, the evidence does not support that children with asthma are at an increased risk of COVID-19 morbidity or mortality compared with children without asthma. Asthma medications do not appear to contribute to incidence or severity of COVID-19 disease. However, there is a high perceived risk of in-person learning that is partially related to how it is portrayed in the media. There is little guidance regarding transitioning asthmatic children back to school and how to properly counsel on mediation of risk. There are differences regionally and locally around school reopening, exemptions, and their implementation. To narrow the divide between perceived and actual risk, clear consistent and ongoing communication will be necessary.

Food allergy management in child care centers and schools is a controversial topic, for which evidence-based guidance is needed. Following the Grading of Recommendations Assessment, Development, and Evaluation approach, we conducted systematic literature reviews of the anticipated health effects of selected interventions for managing food allergy in child care centers and schools; we compiled data about the costs, feasibility, acceptability, and effects on health equity of the selected interventions; and we developed the following conditional recommendations: we suggest that child care centers and schools implement allergy training and action plans; we suggest that they use epinephrine (adrenaline) to treat suspected anaphylaxis; we suggest that they stock unassigned epinephrine autoinjectors, instead of requiring students to supply their own personal autoinjectors to be stored on site for designated at-school use; and we suggest that they do not implement site-wide food prohibitions (eg, "nut-free" schools) or allergen-restricted zones (eg, "milk-free" tables), except in the special circumstances identified in this document. The recommendations are labeled "conditional" due to the low quality of available evidence. More research is needed to determine with greater certainty which interventions are likely to be the most beneficial. Policymakers might need to adapt the recommendations to fit local circumstances.

Risk is a concept inherent in every medical procedure. It can be defined as the probability of an adverse event in a defined population over a specified period of time. In the frame of food allergy management, it might be related to a diagnostic procedure, a treatment, or the consumption of foods. The risk of an adverse event can also be augmented by individual factors. This rostrum article discusses various aspects faced by children with food allergies in the light of risk, and their practical implications. Identifying personal risks for severe reaction, such unstable asthma, and correcting them whenever possible also contributes to a reduction of the risk inherent to food allergy. Among the facets discussed, oral food challenges (OFC) are the most common diagnostic procedures implying an inherent risk. The risk of OFCs can be minimized by correct indication and timing of the test, a safe setting, as well as by ensuring that the patient is otherwise well without potential stressor potentially increasing the risk of a more severe reaction. Oral immunotherapy (OIT) has been studied as a potential treatment for increasing the threshold dose for reaction, and thus reducing the risk of accidental reaction. Nevertheless, the procedure is not devoid of risk as the patients may, and do often react, during the course of the procedure. Ingestion of trace amounts in processed foods, mainly in community settings such as restaurants, schools or day care, represent a potential risk of reactions, although for a minority of patients. Precautionary allergen labelling (PAL) is a wide spread strategy to reduce the potential risk of reactions due to traces. However, PAL is currently inefficient due to inconsistent labelling, also not indicating a clear maximum amount possibly present in the manufactured food. Finally, cost-effectiveness needs to be considered in risk management, as many risk-reduction procedures are clearly not cost-effective.

Purpose of review To summarize the impact of the COVID-19 pandemic on the practice of paediatric allergy. Recent findings Given significant overlap in symptoms, care must be taken to differentiate routine allergic conditions from COVID-19 infection but it appears that most allergic diseases are not risk factors for a severe COVID-19 course. The full impact of restricted allergy/immunology ambulatory services will take months to years to fully understand. One benefit of having to adapt practice style is greater awareness and acceptance of shared decision-making and recognition of preference-sensitive care options in food allergy, in particular for approaches towards allergy prevention, treatment, and anaphylaxis care. Social distancing and masks have helped reduce spread of common respiratory viruses, which may be helping to lower the incidence of viral-associated wheezing episodes, enhancing evidence of the effects of preventing exposure of young children to respiratory viruses on asthma pathogenesis, as well as on allergic rhinitis. There has been a revolution in the rise of telemedicine to increase access to high-quality allergy/immunology specialty care. Summary Although the field has adapted to remain operational in the face of a significant challenge, it is important to apply lessons learned to evolve patient care and optimize treatment in the aftermath of the pandemic.

Background The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). Objective We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study. Methods Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment. Results Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose of ≥1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%). Conclusions These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.

Peanut allergy is an important public health concern and causes substantial psychosocial comorbidity. Although fatal anaphylaxis is rare (occurring at 0·03-0·3 per million person-years in the general population), peanuts are one of the most frequent causes of food allergy mortality. The Learning Early About Peanut study transformed prevention of peanut allergy by showing that early introduction of peanut into the diet of children at high risk (ie, those with an egg allergy or severe eczema) reduced the relative risk of peanut allergy at age 5 years by 81%. Following publication of this study, the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, convened an expert panel, which recommended that, for infants with severe eczema or egg allergy, health professionals should strongly consider evaluation with peanut-specific serological IgE or skin prick test (or both) and, if necessary, an oral food challenge before peanut introduction. In the USA, depending on test results, peanut-containing foods are recommended to be introduced from age 4-6 months in infants with severe eczema or egg allergy. Early introduction to peanuts is also advocated for children with either mild to moderate or no eczema, and in children who are not allergic to egg, but without screening before peanut introduction. However, the NIAID addendum guidelines contrast with other international approaches that do not advocate for allergy screening at a population level before introducing peanuts into infants' diets. In this Review, we evaluate the advantages and disadvantages of a pre-emptive screening approach before the early introduction of peanuts in infants at high risk of peanut allergy.

Background Shared decision making (SDM) is the process through which patients and their medical provider mutually explore therapy goals, risk/benefit, and treatment options regarding medical care. Decision aids are tools that aid in the process of values clarification and help assess decisional needs and potential decisional conflicts. Objective To develop and assess acceptability of a decision aid for commercial peanut allergy therapies. Methods The creation of this decision aid occurred in 3 stages, including a qualitative study to assess decisional needs, development of a draft decision aid through multiple iterations in accordance with international guidelines and decision aid experts, and assessment of decisional acceptability, decisional conflict, and decisional self-efficacy related to using the decision aid. Results The decision aid went through 9 iterations, resulting in a 4-page aid with 7 parts, explaining the therapies, key risks and benefits of therapy choices, relative importance of key attributes of the therapies, and a self-check assessment regarding informational adequacy and how to take the next steps. A total of 24 subjects assessed the decision aid, noting it had good acceptability, high decisional self-efficacy (mean score 91.9/100), and low decisional conflict (mean score 20.2/100). Respondents rated the information content as adequate and sufficient and the information regarding the therapy choices as fair and balanced without a clear bias or presenting a “best choice.” Conclusion We have developed this decision aid as a tool to help caregivers navigate the complexity of decision making for peanut allergy treatment options. The decision aid was noted to have good acceptability, with scores reflective of the instrument enhancing decisional self-efficacy and reducing decisional conflict.

Background Peanut allergy is a potentially severe and lifelong allergy, with few effective treatments or preventive measures. Objective To convene an expert panel of allergists, pediatricians, and advocates to discuss and highlight unmet needs in the prevention and management of peanut allergies. Methods Literature searches of PubMed were performed. The panel evaluated published data on the prevention of peanut allergy, treatment of existing peanut allergy, and management of reactions after unintentional peanut exposures. Results The following key unmet needs in the prevention and management of peanut allergy were identified: (1) enhancing and optimizing implementation of early peanut introduction as a means of preventing the development of peanut allergy, (2) developing knowledge translation strategies regarding the safety and efficacy data for current and emerging immunotherapies for peanut-allergic children to support their use in clinical practice, and (3) promoting understanding of true exposure risk in allergic individuals and ensuring access to epinephrine for unintentional exposures that provoke severe reactions. Practitioners should help educate caregivers about the actual risks associated with peanut allergy and its prevention and management so that treatment decisions can be evidence based rather than fear based. Support tools are needed to help address caregiver goals, expectations, and psychological barriers, as well as identify facilitators for prevention and treatment strategies. Conclusion There are significant unmet needs in our understanding of peanut allergy; addressing these needs will help to enhance understanding of how to most effectively prevent and treat peanut allergy, as well as educate the food-allergic and nonallergic community regarding current evidence-based practices.

Purpose of review To review phenotyping and risk classification of penicillin allergy and provide an update on penicillin allergy delabeling strategies for primary care. Recent findings Beta-lactams are considered the treatment of choice for a wide range of bacterial pathogens; however, many patients receive second-line agents due to being labeled as having an allergy to penicillin. This approach can lead to antibiotic resistance and inferior health outcomes. While 10% of the population is labeled as penicillin allergic, penicillin anaphylaxis occurs in less than 1% of patients. For patients with delayed benign skin rashes (e.g., urticaria or maculopapular exanthem >1 h after administration) attributable to beta-lactam administration occurring more than 12 months ago, direct oral challenge (rechallenge with antibiotic in the clinical setting) can be a safe and effective strategy, with immediate reactions occurring in less than 5% of such low-risk patients and delayed reactions appearing infrequently. In patients with penicillin-associated immediate urticaria, other IgE-mediated features, or anaphylaxis, further allergy evaluation and penicillin skin testing is warranted. Any severe idiosyncratic cutaneous adverse reaction is rare, but can be dangerous so prompt removal of the inciting agent is required. Summary Penicillin allergy delabeling is a high-value service that can be effectively delivered through a multidisciplinary collaborative approach.

Background Biologic therapy is a paradigm-shifting management strategy for many patients with asthma and chronic urticaria, but concerns for therapy-associated anaphylaxis may limit access to these therapies for patients unable to travel to medical clinics. Objective To characterize the cost-effectiveness of in-clinic versus at-home biologic therapy with omalizumab and mepolizumab. Methods Economic evaluation using microsimulations was performed from societal and health care sector perspectives for patients with asthma or chronic spontaneous urticaria receiving omalizumab or mepolizumab in an allergy clinic, primary care provider (PCP) office, or at home over a 1-year time horizon (12 injections per year in each base case with sensitivity analysis to 24 injections per year). Travel times and distances were applied to a population attending a tertiary care allergy clinic in Northern New England receiving omalizumab or mepolizumab, using a willingness-to-pay value of $10 million per death prevented and in-clinic administration reducing anaphylaxis fatality and hospitalization 10- to100-fold. Deterministic and probabilistic sensitivity analyses were performed. Results One-way allergy clinic travel distances significantly exceeded local PCP offices (49 miles, 95% CI, 42-56, vs 12 miles, 95% CI, 10-15). In the omalizumab societal analysis, annual PCP and allergy clinic administration cost $1369.14 (mean) ± $51.33 (SD) and $1916.68 ± $40.86, respectively. Small reductions in medication-related fatalities with in-clinic administration were offset by the potential increase in automobile fatalities resulting from traveling to the allergy clinic (14.6 ± 15.0 per million person-years for this strategy). Compared with at-home administration, in-clinic omalizumab administration was not cost-effective, with an incremental cost-effectiveness ratio of $500,648,430 (PCP), and with allergy clinic administration dominated by higher costs and automobile-related fatalities. Routine mepolizumab clinic administration was dominated by at-home administration unless anaphylaxis rates or self-administration teaching costs were high. Conclusions For many patients, at-home administration of omalizumab or mepolizumab may be a cost-effective strategy.

BackgroundThe long-term sequelae of coronavirus disease 2019 (COVID-19) in children remain poorly characterised. This study aimed to assess long-term outcomes in children previously hospitalised with COVID-19 and associated risk factors.MethodsThis is a prospective cohort study of children (≤18 years old) admitted to hospital with confirmed COVID-19. Children admitted between 2 April 2020 and 26 August 2020 were included. Telephone interviews used the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) COVID-19 Health and Wellbeing Follow-up Survey for Children. Persistent symptoms (>5 months) were further categorised by system(s) involved.Results518 out of 853 (61%) eligible children were available for the follow-up assessment and included in the study. Median (interquartile range (IQR)) age was 10.4 (3–15.2) years and 270 (52.1%) were girls. Median (IQR) follow-up since hospital discharge was 256 (223–271) days. At the time of the follow-up interview 126 (24.3%) participants reported persistent symptoms, among which fatigue (53, 10.7%), sleep disturbance (36, 6.9%) and sensory problems (29, 5.6%) were the most common. Multiple symptoms were experienced by 44 (8.4%) participants. Risk factors for persistent symptoms were: older age “6–11 years” (OR 2.74, 95% CI 1.37–5.75) and “12–18 years” (OR 2.68, 95% CI 1.41–5.4), and a history of allergic diseases (OR 1.67, 95% CI 1.04–2.67).ConclusionsA quarter of children experienced persistent symptoms months after hospitalisation with acute COVID-19 infection, with almost one in 10 experiencing multisystem involvement. Older age and allergic diseases were associated with higher risk of persistent symptoms at follow-up.

Peanut allergy that affects 1.4–4.5% of North American children, has increased in prevalence in the past 20 years, is often diagnosed early in life, and outgrown in fewer than 20–32% of children by age 6. Recent self-reported data suggest that over 50% of peanut allergic individuals have had a severe reaction. Because food (and peanut in particular) is a ubiquitous part of school attendance, this raises the potential for reactions to accidental peanut ingestion at school. Accordingly, there is increasing interest in creating policy to protect peanut allergic children in the school environment—sometimes as a ban on peanut-containing items either in the classroom, the lunchroom, or even in the entire facility. We review the evidence for, and against, peanut bans in schools.

Shared decision making was first highlighted in a report by the Institute of Medicine in 2001. The primary aim of this initiative was to improve the quality of care provided to patients in the United States by creating a health care system that is safe, effective, efficient, and equitable. Currently, medical decision making is based on a patient-centered approach, with the individual's preferences, needs, and values guiding optimal care. Patients are frequently faced with various treatment choices with no absolute guarantee of any desired outcome and no clear indication of the "best or least worse" option. In fact, in healthcare, each of these options usually has potential trade-offs and outcomes. The process of how to choose a particular option becomes a discussion where the clinician and the patient have to jointly review the medical evidence, but also the patient's openness and preference for balancing particular attributes of the treatment (both positive and negative). Shared decision making is important for chronic diseases that require long-term management, such as most allergic conditions, including food allergies. The landscape of food allergies has changed considerably in recent years with multiple and significant scientific advances in both diagnostics and treatment, providing an ideal field for the use of shared decision making. For the purposes of this review, we will discuss different areas of food allergy management within a single complex case, focusing on the role of shared decision making.

Background: Food allergies are a significant public health issue, and the only effective management option currently available is strict avoidance of all foods containing the allergen. In view of the practical impossibility of limiting risks to zero, quantitative allergen risk assessment and management strategies are needed. Objective: We sought to develop appropriate methods for informing population-based risk assessments and risk management programs to benefit all stakeholders but particularly patients with food allergy. Methods: Individual thresholds for food allergens (maximum tolerable doses and minimum eliciting doses) can ideally be established through double-blind, placebo-controlled food challenges. If double-blind, placebo-controlled food challenge data are not available, data from widely used open food challenges using predefined objective criteria can also provide useful data regarding minimum eliciting doses. For more than 20 years, the Netherlands Organisation for Applied Scientific Research and the Food Allergy Research and Resource Program at the University of Nebraska-Lincoln have been collecting individual maximum tolerable doses and minimum eliciting doses that produce objective symptoms from published and unpublished clinical data to better refine knowledge regarding the sensitivity of the population to food allergens. Results: In this article we provide in-depth insights into the methodology applied by the Netherlands Organisation for Applied Scientific Research and Food Allergy Research and Resource Program to derive individual maximum tolerable doses and minimum eliciting doses for objective symptoms from clinical food challenge data. More than 90 examples for determining individual allergic thresholds are presented. Conclusion: With the methodology presented in this article, we aim to stimulate harmonization and transparency in quantitative food allergen risk assessment and risk management programs, encouraging their wider adoption. © 2019 American Academy of Allergy, Asthma & Immunology

BackgroundThe long-term sequelae of coronavirus disease 2019 (Covid-19) in children remain poorly characterised. This study aimed to assess long-term outcomes in children previously hospitalised with Covid-19 and associated risk factors. MethodsThis is a prospective cohort study of children ([≤]18 years old) admitted with confirmed Covid-19 to Z.A. Bashlyaeva Childrens Municipal Clinical Hospital in Moscow, Russia. Children admitted to the hospital during the first wave of the pandemic, between April 2, 2020 and August 26, 2020, were included. Telephone interview using the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Covid-19 Health and Wellbeing paediatric follow up survey. Persistent symptoms (>5 months) were further categorised by system(s) involved. FindingsOverall, 518 of 853 (61%) of eligible children were available for the follow-up assessment and included in the study. Median age was 10.4 years (IQR, 3-15.2) and 270 (52.1%) were girls; median follow-up since hospital discharge was 256 (223-271) days. At the time of the follow-up interview 126 (24.3%) participants reported persistent symptoms among which fatigue (53, 10.7%), sleep disturbance (36, 6.9%,) and sensory problems (29, 5.6%) were the most common. Multiple symptoms were experienced by 44 (8.4%) participants. Risk factors for persistent symptoms were: age "6-11 years" (odds ratio 2.74 (95% confidence interval 1.37 to 5.75) and "12-18 years" (2.68, 1.41 to 5.4), and a history of allergic diseases (1.67, 1.04 to 2.67). InterpretationA quarter of children experienced persistent symptoms months after hospitalization with acute covid-19 infection, with almost one in ten experiencing multi-system involvement. Older age and allergic diseases were associated with higher risk of persistent symptoms at follow-up. Our findings highlight the need for replication and further investigation of potential mechanisms as well as clinical support to improve long term outcomes in children. FundingNone. O_TEXTBOXResearch in contextO_ST_ABSEvidence before this studyC_ST_ABSEvidence suggests that Covid-19 may result in short- and long-term consequences to health. Studies in children and adolescents are limited and available evidence is scarce. We searched Embase for publications from inception to April, 25, 2021, using the following phrases or combinations of phrases "post-covid condition" or "post-covid syndrome" or "covid sequalae" or "post-acute covid" or "long covid" or "long hauler" with "pediatric*" or "paediatric*" or "child*" or "infant*" or "newborn*" or "toddler*" or "neonate*" or "neonatal" or "adolescent*" or "teen*". We found small case series and small cohort studies looking at Covid-19 consequences in children. No large cohort studies of previously hospitalised children, assessing symptom duration, categorisation or attempting multivariable analyses to identify independent risk factors for long Covid development were identified. Added value of this studyTo our knowledge, this is the largest cohort study with the longest follow-up since hospital discharge of previously hospitalised children. We found that even months after discharge from the hospital, approximately a quarter of children experience persistent symptoms with one in ten having multi-system involvement. Older age and allergic diseases are associated with Covid-19 consequences. Parents of some children report emotional and behavioural changes in their children after Covid-19. Implications of all the available evidenceOur findings highlight the need for continued global research of Covid-19 consequences in the paediatric population. Older children admitted to the hospital should be carefully monitored upon discharge. Large, controlled studies aiming to identify risk groups and potential intervention strategies are required to fill knowledge gaps. C_TEXTBOX

Background The coronavirus disease 2019 pandemic has highlighted the importance of accurate capture of vaccine, and vaccine component, allergy. There remains a gap in the prevalence literature from the perspective of direct primary care provider (PCP) reporting at a population level. Objective To determine the prevalence of PCP-documented vaccine and polyethylene glycol (PEG) allergy using electronic medical record data from the Canadian Primary Care Sentinel Surveillance Network. Methods Retrospective cohort study using the Canadian Primary Care Sentinel Surveillance Network repository. Machine learning algorithms were applied to evaluate for vaccine allergy documentation, and Anatomic Therapeutic Chemical codes were used for PEG allergy or allergy to common injectable medications containing PEG (CIMCP). Results The prevalence of PCP-documented vaccine allergy in Canada was 0.037% (395/1,055,677) and of PEG allergy was 0.0009% (10/1,055,677). In total, 0.01% of patients had a documented allergy to either PEG or CIMCP (135/1,055,677). None of the patients with PEG allergy had a documented allergy to a CIMCP. Patients with vaccine allergy and PEG allergy were significantly more likely to have other atopic comorbidities, including asthma (P < .001 for both), eczema (P < .001 and P = .001, respectively), rhinitis (P = .002 and P < .001, respectively), and food allergy (P < .001 for both). Significantly higher rates of depression (P < .001 and P < .001, respectively) and anxiety (P = .003 and P < .001, respectively) were found in those with vaccine allergy, or PEG allergy, than those without vaccine allergy or PEG allergy. Conclusion This is the first study to estimate the prevalence of vaccine and PEG allergy in a national cohort that uses PCP documentation, revealing a low reported rate of vaccine allergy and PEG allergy.

Background Vaccine-associated anaphylaxis is a rare event (1.34 events/million doses; 0.00017% occurrence over 26 years). Several reports of allergic reactions concerning for anaphylaxis have been reported early into the Pfizer-BioNTech and Moderna coronavirus disease 2019 (COVID-19) vaccine campaign in the United States, Canada, and the United Kingdom. Objective To perform a cost-effectiveness analysis characterizing the risks of COVID-19 versus vaccine anaphylaxis, comparing universal COVID-19 vaccination versus risk-stratified vaccination approaches. Methods Cohort analysis models were created to evaluate the cost-effectiveness of universal vaccination versus risk-stratified vaccination (eg, contraindicated in persons with a history of any previous episode of anaphylaxis) with a threshold for cost-effective care at $10,000,000 per death prevented. In the base case, risk of anaphylaxis was estimated at 0.1%, with case-fatality estimated at 0.3%. Results On a population level (n = 300,000,000 simulated persons), universal vaccination was associated with a cost-savings of $503,596,316 and saved 7,607 lives, but the cost-savings was sensitive to increasing rates of vaccine-associated anaphylaxis. The universal strategy dominated at higher rates of COVID-19 infection and low rates of vaccine-associated anaphylaxis in both the health care and societal perspectives. When the risk of vaccine-associated anaphylaxis exceeded 0.8%, the risk-stratified approach to vaccination was the most cost-effective strategy. There was also an interaction between anaphylaxis risk and anaphylaxis fatality, with a risk-stratified approach becoming cost-effective as each risk increased concurrently. Stratified observation time by anaphylaxis history (15 minutes vs 30 minutes) was not cost-effective until a 1% anaphylaxis case-fatality was assumed and risk of vaccine anaphylaxis exceeded 6%. Conclusions This study demonstrates that unless vaccine anaphylaxis rates exceed 0.8%, a universal vaccination approach dominates a risk-stratified approach where persons with any history of anaphylaxis would be contraindicated from vaccination, with lower cost and superior health outcomes.

Concerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of international experts in anaphylaxis composed of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the World Health Organizstion (WHO) global coronavirus database, and the gray literature (inception, March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases per million (n = 41,000,000 vaccinations; 95% confidence interval [95% CI] 4.02-15.59; 26 studies, moderate certainty), the incidence of 0.15 cases per million patient-years (95% CI 0.11-0.2), and the sensitivity for PEG skin testing is poor, although specificity is high (15 studies, very low certainty). We recommend vaccination over either no vaccination or performing SARS-CoV-2 vaccine/excipient screening allergy testing for individuals without history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient, and a shared decision-making paradigm in consultation with an allergy specialist for individuals with a history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient. We recommend further research to clarify SARS-CoV-2 vaccine/vaccine excipient testing utility in individuals potentially allergic to SARS-CoV2 vaccines or their excipients.

Recently published data from high-impact randomized controlled trials indicate the strong potential of strategies to prevent the development of food allergy in high-risk individuals, but guidance in the United States at present is limited to a policy for only the prevention of peanut allergy, despite other data being available and several other countries advocating early egg and peanut introduction. Eczema is considered the highest risk factor for developing IgE-mediated food allergy, but children without risk factors still develop food allergy. To prevent peanut and/or egg allergy, both peanut and egg should be introduced around 6 months of life, but not before 4 months. Screening before introduction is not required, but may be preferred by some families. Other allergens should be introduced around this time as well. Upon introducing complementary foods, infants should be fed a diverse diet, because this may help foster prevention of food allergy. There is no protective benefit from the use of hydrolyzed formula in the first year of life against food allergy or food sensitization. Maternal exclusion of common allergens during pregnancy and/or lactation as a means to prevent food allergy is not recommended. Although exclusive breast-feeding is universally recommended for all mothers, there is no specific association between exclusive breast-feeding and the primary prevention of any specific food allergy.

Purpose of review Introduction of peanut during the first year of life is associated with an 81% relative risk reduction of developing peanut allergy in infants with severe eczema, egg allergy, or both. However, significant international variation exists in risk stratification prior to peanut introduction. Recent findings A policy-level screening approach, such as the one in the United States, is not practical and is associated with higher costs and more cases of peanut allergy over time, in contrast to international models that recommend universal early introduction without prescreening. In Australia, population-level efforts to introduce peanut early without screening have demonstrated high rates of peanut introduction before 12 months of age and low rates of severe allergic reactions. In contrast, screening prior to peanut introduction in the United States is associated with 'screening creep' - the tendency of clinicians to test populations where screening is not recommended. Summary Early peanut introduction can reduce the risk of developing food allergy and is more effective without a risk-based screening approach. In some circumstances, shared clinical decision-making can facilitate food allergy prevention in a manner consistent with family values and preferences.

Six years ago, the Learning Early About Peanut (LEAP) trial findings helped fundamentally shift the paradigm of peanut allergy prevention. Although the results of LEAP are well accepted, policy-makers, caregivers, and clinicians struggle with how best to implement and apply the study's key findings in clinical practice. Differences in guidelines highlight issues related to peanut allergy prevention implementation, including caregiver acceptability, cost, fidelity, feasibility, appropriateness, and adoption. The goals of this rostrum are to review how the LEAP study has informed international peanut allergy prevention policy, as well as to review the strengths and ongoing controversies in peanut allergy prevention implementation.

Rationale: Allergic diseases are an increasing public health concern, and early life environment is critical to immune development. Maternal diet during pregnancy has been linked to offspring allergy risk. In turn, maternal diet is a potentially modifiable factor, which could be targeted as an allergy prevention strategy. In this systematic review, we focused on non-allergen-specific modifying factors of the maternal diet in pregnancy on allergy outcomes in their offspring. Methods: We undertook a systematic review of studies investigating the association between maternal diet during pregnancy and allergic outcomes (asthma/wheeze, hay fever/allergic rhinitis/seasonal allergies, eczema/atopic dermatitis (AD), food allergies, and allergic sensitization) in offspring. Studies evaluating the effect of food allergen intake were excluded. We searched three bibliographic databases (MEDLINE, EMBASE, and Web of Science) through February 26, 2019. Evidence was critically appraised using modified versions of the Cochrane Collaboration Risk of Bias tool for intervention trials and the National Institute for Clinical Excellence methodological checklist for cohort and case-control studies and meta-analysis performed from RCTs. Results: We identified 95 papers: 17 RCTs and 78 observational (case-control, cross-sectional, and cohort) studies. Observational studies varied in design and dietary intakes and often had contradictory findings. Based on our meta-analysis, RCTs showed that vitamin D supplementation (OR: 0.72; 95% CI: 0.56-0.92) is associated with a reduced risk of wheeze/asthma. A positive trend for omega-3 fatty acids was observed for asthma/wheeze, but this did not reach statistical significance (OR: 0.70; 95% CI: 0.45-1.08). Omega-3 supplementation was also associated with a non-significant decreased risk of allergic rhinitis (OR: 0.76; 95% CI: 0.56-1.04). Neither vitamin D nor omega-3 fatty acids were associated with an altered risk of AD or food allergy. Conclusions: Prenatal supplementation with vitamin D may have beneficial effects for prevention of asthma. Additional nutritional factors seem to be required for modulating the risk of skin and gastrointestinal outcomes. We found no consistent evidence regarding other dietary factors, perhaps due to differences in study design and host features that were not considered. While confirmatory studies are required, there is also a need for performing RCTs beyond single nutrients/foods.

Asthma remains one of the most important challenges to pediatric public health in the US. A large majority of children with persistent and chronic asthma demonstrate aeroallergen sensitization, which remains a pivotal risk factor associated with the development of persistent, progressive asthma throughout life. In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma. The cascade of biological responses to allergens is primarily mediated through IgE antibodies and their production is further stimulated by IgE responses to antigen exposure. In addition, circulating IgE impairs innate anti-viral immune responses. The latter effect could magnify the effects of another early life exposure associated with increased risk of the development of asthma – viral infections. Omalizumab binds to circulating IgE and thus ablates antigen signaling through IgE-related mechanisms. Further, it has been shown restore IFN-α response to rhinovirus and to reduce asthma exacerbations during the viral season. We therefore hypothesized that early blockade of IgE and IgE mediated responses with omalizumab would prevent the development and reduce the severity of asthma in those at high risk for developing asthma. Herein, we describe a double-blind, placebo-controlled trial of omalizumab in 2–3 year old children at high risk for development of asthma to prevent the development and reduce the severity of asthma. We describe the rationale, methods, and lessons learned in implementing this potentially transformative trial aimed at prevention of asthma.

In early 2020, the first US and Canadian cases of the novel severe acute respiratory syndrome coronavirus 2 infection were detected. In the ensuing months, there has been rapid spread of the infection. In March 2020, in response to the virus, state/provincial and local governments instituted shelter-in-place orders, and nonessential ambulatory care was significantly curtailed, including allergy/immunology services. With rates of new infections and fatalities potentially reaching a plateau and/or declining, restrictions on provision of routine ambulatory care are lifting, and there is a need to help guide the allergy/immunology clinician on how to reinitiate services. Given the fact that coronavirus disease 2019 will circulate within our communities for months or longer, we present a flexible, algorithmic best-practices planning approach on how to prioritize services, in 4 stratified phases of reopening according to community risk level, as well as highlight key considerations for how to safely do so. The decisions on what services to offer and how fast to proceed are left to the discretion of the individual clinician and practice, operating in accordance with state and local ordinances with respect to the level of nonessential ambulatory care that can be provided. Clear communication with staff and patients before and after all changes should be incorporated into this new paradigm on continual change, given the movement may be forward and even backward through the phases because this is an evolving situation.

The SARS-CoV2 pandemic has prompted a re-evaluation of our current practice of medicine. The seemingly abrupt worldwide spread of this disease resulted in immediate changes and a reduction in many allergy-focussed services and procedures. The reality of the long-term circulation of this virus in our communities requires us to evolve as a specialty. In this article, we outline current and future challenges in the management of food allergy in light of coronavirus disease 2019 (COVID-19). We focus on infant food allergy prevention, management of anaphylaxis, accurate diagnosis with oral food challenges, and active management of food allergy with oral immunotherapy. This article identifies the challenges of conflicting guidelines, shortcomings of acute management approaches, and inherent system deficiencies. We offer perspectives and strategies that can be implemented now, including an evaluation of virtual care and telemedicine for the management of food allergy. The use of a shared decision-making model results in novel approaches that can benefit our patients and our specialty for years to come. COVID-19 has forced us to re-evaluate our current way of thinking about food allergy management to better treat our patients.

In the wake of the COVID-19 pandemic and massive disruptions to daily life in the spring of 2020, in May 2020, the Centers for Disease Control (CDC) released guidance recommendations for schools regarding how to have students attend while adhering to principles of how to reduce the risk of contracting SARS-CoV-2. As part of physical distancing measures, the CDC is recommending that schools who traditionally have had students eat in a cafeteria or common large space instead have children eat their lunch or other meals in the classroom at already physically distanced desks. This has sparked concern for the safety of food-allergic children attending school, and some question of how the new CDC recommendations can coexist with recommendations in the 2013 CDC Voluntary Guidelines on Managing Food Allergy in Schools as well as accommodations that students may be afforded through disability law that may have previously prohibited eating in the classroom. This expert consensus explores the issues related to evidence-based management of food allergy at school, the issues of managing the health of children attending school that are acutely posed by the constraints of an infectious pandemic, and how to harmonize these needs so that all children can attend school with minimal risk from both an infectious and allergic standpoint.

The oral food challenge (OFC) is the criterion standard for diagnosing food allergy, but prior studies indicate many allergists may not be using OFCs for various reasons. To better understand current OFC trends, practices, and barriers, the American Academy of Allergy Asthma and Immunology (AAAAI) Adverse Reactions to Foods Committee subcommittee updated a 19-item survey (previously administered in 2009) and sent it to AAAAI and American College of Allergy, Asthma, and Immunology (ACAAI) membership. There were a total of 546 respondents who represented approximately a 10% response rate. Among the 546 respondents, compared with 2009, significantly more providers offer OFCs (95% vs 84.5%), offer10 OFCs per month (17% vs 5.6%), obtain informed consent (82.2% vs 53.6%), and performed OFCs in fellowship (71% vs 45%) (all P.001). Fellowship OFC training was limited, with 56% performing10 OFCs in fellowship and 29% performing none. Although 94% see patients12 months of age, 35.5% do not offer OFCs for early peanut introduction. Although 79% dedicate a supervising medical provider (MD, NP, PA) and 86% have a written OFC protocol, only 60% had a standardized reaction treatment protocol and 56% prepared emergency medications before OFC. Compared with 2009, there was significant worsening of perceived barriers to performing OFCs, including time (65.6% vs 55%), space (55.3% vs 27.1%), staffing (59.6% vs 44.3%), experience (16.9% vs 11.5%), and hospital proximity (10.9% vs 7.9%), though reimbursement as a barrier improved (45.9% vs 53.7%) (all P.01). Compared with 2009, although more providers offer OFCs, multiple perceived barriers to performing OFCs have worsened. Hesitancy to challenge infants and emergency preparedness issues are emerging potential concerns.

Given the burden of disease and the consequences of a diagnosis of peanut allergy, it is important that peanut allergy be accurately diagnosed so that an appropriate treatment plan can be developed. However, a test that indicates there is peanut sensitization present (eg, a "positive" test) is not always associated with clinical reactivity. This practice parameter addresses the diagnosis of IgE-mediated peanut allergy, both in children and adults, as pertaining to 3 fundamental questions, and based on the systematic reviews and meta-analyses, makes recommendations for the clinician who is evaluating a patient for peanut allergy. These questions relate to when diagnostic tests should be completed, which diagnostic tests to utilize, and the utility (or lack thereof) of diagnostic testing to predict the severity of a future allergic reaction to peanut.

Eosinophilic esophagitis (EoE) is a chronic inflammatory condition of the esophagus. Many new studies have been reported recently that describe EoE management. An expert panel was convened by the American Gastroenterological Association Institute and the Joint Task Force on Allergy-Immunology Practice Parameters to provide a technical review to be used as the basis for an updated clinical guideline. This technical review was developed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. Eighteen focused EoE management questions were considered, with 15 answered using the GRADE framework and 3 with a narrative summary. There is moderate certainty in the evidence that topical glucocorticosteroids effectively reduce esophageal eosinophil counts to

Objective Shared decision-making is a patient-centered approach that involves a mutual discussion about management or treatment options, which account for the patient's underlying values and preferences for therapy. Little is known about the role of shared decision-making in the care of patients with food allergy. Data Sources A narrative review of the shared decision-making and food allergy outcomes literature in the past 20 years was performed. Results In shared decision-making, care must be taken to help clarify the patient's values regarding their care options, but not instill the clinician's values or preferences into that choice. It is essential to understand the mutual roles of the clinician in the process of providing evidence-based options for care, advocating for treatments that are aligned with their goals and preferences, and allowing patients to make fully informed decisions within this paradigm. Decision support tools such as decision aids can assist patients in the values clarification process, particularly in which preference-sensitive care exists, in which options hold significant tradeoffs and varying outcomes, and the decision is reflective of personal values and preferences. There are multiple potential preference-sensitive care scenarios in food allergy in which shared decision-making could be optimized, including the development of decision aids. These areas include early allergenic solid introduction, preemptive epinephrine use in which there is allergen exposure but no symptoms, automatic activation of EMS after using epinephrine, and choices of food allergy treatment. Only one decision aid in food allergy exists. Conclusion Shared decision-making is an approach that could greatly enhance food allergy care and improve patient-reported outcomes.

To fully understand the role of diet diversity on allergy outcomes and to set standards for conducting research in this field, the European Academy of Allergy and Clinical Immunology Task Force on Diet and Immunomodulation has systematically explored the association between diet diversity and allergy outcomes. In addition, a detailed narrative review of information on diet quality and diet patterns as they pertain to allergic outcomes is presented. Overall, we recommend that infants of any risk category for allergic disease should have a diverse diet, given no evidence of harm and some potential association of benefit in the prevention of particular allergic outcomes. In order to harmonize methods for future data collection and reporting, the task force members propose relevant definitions and important factors for consideration, when measuring diet diversity in the context of allergy. Consensus was achieved on practice points through the Delphi method. It is hoped that the definitions and considerations described herein will also enable better comparison of future studies and improve mechanistic studies and pathway analysis to understand how diet diversity modulates allergic outcomes.

Background Both oral immunotherapy (OIT) and epicutaneous immunotherapy (EPIT) are emerging potential treatments for peanut allergy. Caregiver goals and expectations of these therapies are poorly defined. Objective To determine caregiver goals and expectations of food allergy therapy. Methods Twenty-two detailed, semistructured interviews of OIT and EPIT caregivers were conducted, allowing caregivers to describe their motivations for and experiences with food allergy therapy and life with a peanut allergic child. Results In this sample, caregivers of peanut allergic children enrolled in OIT or EPIT phase 3 trials expressed a primary goal for their child to develop a buffer against an unintentional peanut exposure. The perception of the buffer varied, representing a decreased reaction severity on exposure, increased time to react to allow for assessment, or increased threshold of peanut exposure tolerated. Although caregivers expressed that a buffer may increase their confidence in travel and dining outside the home, they do not anticipate this buffer would lessen their overall level of pretherapy anxiety, allergen-associated vigilance, or avoidance practices. Most of the caregivers hope the buffer will increase their and their child's perceived sense of freedom for the child's actions and social interactions, translating to quality of life improvement, while still respecting the limitations of having a severe allergy that has been partially treated. No caregiver viewed these therapies as a cure, and most viewed treatment as a supplement to their current avoidance practices. Conclusion Caregivers of peanut allergic children strongly desire that OIT and EPIT result in a buffer against an unintentional reaction, although most admitted that this would not significantly change their anxiety and family's current lifestyle.

BACKGROUND Studies suggest early egg introduction (EEI) in the first year of life is associated with reduced risk of developing egg allergy. No US recommendations exist regarding optimally implementing EEI. METHODS Using simulation and Markov modelling over a 20-year horizon, we explored optimal EEI strategies applied to US, European and Canadian populations, comparing screening of high-risk infants (skin prick testing [SPT] or serum-specific IgE[sIgE]) before introducing cooked egg at 6 months of life vs egg introduction at home, without screening, for all infants. RESULTS A no-screen approach dominated egg SPT screening of high-risk infants with early-onset eczema. Base model per-patient incremental costs of SPT were $6865 US dollars (USD), 6801 euros and $10 610 Canadian dollars (CAD). For egg sIgE screening in primary care settings, base model incremental costs were $16 722 USD, 18 072 euros and $28 193 CAD. As the simulation concluded 2.5% were egg allergic without screening vs 9.5%, 12% and 21.4% of children undergoing SPT, delayed introduction or sIgE screening. Incremental societal costs from screening reached $2 009 351 175 USD for SPT and $4 894 445 790 USD for sIgE testing. In sensitivity analyses, if the risk of reaction with initial egg ingestion was ≥22.5%, SPT before EEI became a preferred strategy. A no-screen approach dominated both EEI of raw pasteurized egg and delayed cooked egg introduction approaches. CONCLUSIONS Assuming initial reaction rates

Objective To review the evidence and current policies regarding the use of epinephrine at schools and child care centers Data Sources and Study Selections A narrative review was performed based on the result of conference proceedings of a group of interprofessional stakeholders who attended the USAnaphylaxis Summit 2017 presented by Allergy & Asthma Network. Results Anaphylaxis is a well-recognized medical emergency that requires prompt treatment with intramuscular epinephrine. Anaphylaxis can be associated with poor quality of life. There is renewed recent focus on anaphylaxis management in schools. This interest has been spurred by an increase in the number of children with food allergy who are attending school, data that support up to 25% of first-time anaphylactic events occurring on school grounds, and a well-publicized fatality that helped to initiate a movement for stock, undesignated, non–student-specific epinephrine. Stock epinephrine is now available in 49 states, with an increasing number of states instituting mandatory reporting for use of such devices. Nursing efforts are paramount to support and implement stock epinephrine programs. Many states do not have clarity on delegation of authority for who can administer stock epinephrine, and there is evidence of variability in storage of stock devices. Few states have outcomes data that support successful implementation of stock epinephrine programs. Conclusion Additional data are needed to demonstrate successful implementations of stock epinephrine programs and their outcomes. Such programs should include support for school nursing and clearer delineation of authority for medication administration as well as standards for where and how devices are stored.

Background Eosinophilic esophagitis (EoE) is a chronic, inflammatory disease of the esophagus that currently requires repeated endoscopic biopsies for diagnosis and monitoring because no reliable noninvasive markers have been identified. Objective To identify promising minimally invasive EoE biomarkers and remaining gaps in biomarker validation. Methods We performed a systematic review of EMBASE, Ovid MEDLINE, PubMed, and Web of Science from inception to June 6, 2017. Studies were included if patients met the 2007 consensus criteria for EoE diagnosis, a minimally invasive biomarker was assessed, and the study included at least 1 control for comparison. Results The search identified 2094 studies, with 234 reviewed at full-text level, and 49 included in the analysis (20 adult, 19 pediatric, 7 pediatric and adult, and 3 not stated). Most (26 of 49) were published after 2014. Thirty-five studies included healthy controls, 9 analyzed atopic controls, and 29 compared samples from patients with active and inactive EoE. Minimally invasive biomarkers were obtained from peripheral blood (n = 41 studies), sponge or string samples (n = 3), oral or throat swab secretions (n = 2), breath condensate (n = 2), stool (n = 2), and urine (n = 2). The most commonly reported biomarkers were peripheral blood eosinophils (n = 16), blood and string eosinophil granule proteins (n = 14), and eosinophil surface or intracellular markers (n = 12). EoE biomarkers distinguished active EoE from healthy controls in 23 studies, atopic controls in 2 studies, and inactive EoE controls in 20 studies. Conclusion Several promising minimally invasive biomarkers for EoE have emerged; however, few are able to differentiate EoE from other atopic diseases.