Updated Guidance Regarding The Risk ofAllergic Reactions to COVID-19 Vaccines and Recommended Evaluation and Management: A GRADE Assessment, and International Consensus Approach.

This guidance updates 2021 GRADE recomendations regarding immediate allergic reactions following COVID-19 vaccines and addresses re-vaccinating individuals with 1st dose allergic reactions and allergy testing to determine re-vaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 re-vaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommenations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the UK, and the US formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy, and re-vaccination after a prior immediate allergic reaction. We suggest against >15-minute post-vaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest re-vaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise, in a properly equipped setting. We suggest against pre-medication, split-dosing, or special precautions because of a comorbid allergic history.

Temporal trends in anaphylaxis ED visits over the last decade and the effect of COVID-19 pandemic on these trends.

BACKGROUND: Anaphylaxis is an acute systemic and potentially fatal allergic reaction. We evaluated trends in yearly rates of anaphylaxis in a pediatric Emergency Department (ED) in Montreal, Canada. METHODS: A prospective and retrospective recruitment process was used to find families of children who had presented with anaphylaxis at the Montreal Children's Hospital between April 2011 and April 2021. Using a uniform recruitment form, data were collected. Anaphylaxis patterns were compared to clinical triggers using descriptive analysis. RESULTS: Among 830,382 ED visits during the study period, 2726 (26% recruited prospectively) presented with anaphylaxis. The median age was 6 years (IQR: 0.2, 12.00), and 58.7% were males. The relative frequency of anaphylaxis cases doubled between 2011-2015, from 0.22% (95% CI, 0.19, 0.26) to 0.42 March 2020, the total absolute number of anaphylaxis cases and relative frequency declined by 24 cases per month (p < 0.05) and by 0.5% of ED visits (p < 0.05). CONCLUSIONS: The rate of anaphylaxis has changed over the years, representing modifications in food introduction strategies or lifestyle changes. The decrease in the frequency of anaphylaxis presenting to the ED during the COVID pandemic may reflect decreased accidental exposures with reduced social gatherings, closed school, and reluctance to present to ED.

Changes in food-related costs during the COVID-19 pandemic among families managing food allergy.

Background: The COVID-19 pandemic has affected the supply, cost, and demand for certain foods, but it is not clear how these changes have affected food-allergic households. Objective: To describe the changes in food-related costs that have followed COVID-19, as reported by higher- and lower-income households with a food-allergic member. Methods: Between May 1-June 30, 2020, Canadian households, with at least one food-allergic member, completed an online survey on food shopping and preparation habits before and during the COVID-19 pandemic. The sample was divided into binary groups, either higher or lower than the sample median income. Data were analyzed using descriptive statistics and multiple regression. Results: The sample was comprised of 102 participants (i.e., 51/ income group). The three most common food allergies amongst both groups were peanuts, tree nuts and milk. Since the start of the pandemic, both groups reported greater monthly direct grocery costs, although costs amongst the higher-income group were twice as high as the lower-income group ($212.86 vs. $98.89, respectively). Indirect food preparation costs were similarly elevated. Higher-income households with food procurement difficulties reported increased indirect shopping costs following the outbreak of COVID-19, whereas those without such difficulties reported decreased costs. Lower-income households with allergies to milk, wheat, or eggs (i.e., staple allergy) experienced a larger change in indirect food preparation costs following the outbreak of COVID-19 relative to those with other food allergies ($244.58 vs. -$20.28, respectively; p = 0.03). Conclusion: Both higher and lower income households with food allergy reported greater direct food costs and indirect food preparation costs following the COVID-19. Households with staple allergy and those with difficulties finding their typical food items were particularly affected.

Home-Based Peanut Oral Immunotherapy for Low-Risk Peanut-Allergic Preschoolers During the COVID-19 Pandemic and Beyond.

The coronavirus disease 2019 (COVID-19) pandemic has led to the deprioritization of non-emergency services, such as oral food challenges and the initiation of oral immunotherapy (OIT) for food-allergic children. Recent studies have suggested that home-based peanut OIT could be a safe and effective option for low-risk peanut-allergic children. In the period between September 1, 2020, and January 31, 2021, nine preschoolers with a history of mild allergic reactions to peanut underwent home-based peanut OIT. Eight of them (88.9%) completed the build-up phase at home in 11-28 weeks, tolerating a daily maintenance dose of 320 mg peanut protein. During the build-up, six patients (75.0%) reported urticaria, three (33.3%) reported gastrointestinal tract symptoms, and one (14.3%) reported oral pruritis. None of the patients developed anaphylaxis, required epinephrine, or attended emergency services related to OIT. One or two virtual follow-up visits were completed per patient during the build-up phase. Our case series shows that home-based OIT could be offered to the low-risk preschoolers during the COVID-19 pandemic when non-emergency services are limited and could be considered beyond the pandemic, especially for the families living in the rural or remote areas that may otherwise be unable to access OIT.

Development of IMPAACT (Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool), a validated tool to screen for food allergy-associated parental anxiety.

BACKGROUND: Parents commonly experience anxiety owing to their children's food allergies (FAs). Although FA-specific anxiety screening tools for adult and pediatric patients exist, a tool for parents with children with food allergy is lacking. OBJECTIVE: To develop and validate a tool that measures parental anxiety related to their child's FA. METHODS: To construct the instrument, items were developed based on consultations with stakeholders and review of existing literature. The instrument was then pilot tested, and items were modified based on relevance, importance, item-total correlations, and fit with the instrument's overall factor structure. The modified instrument was validated through assessing internal validity (reliability), convergent and discriminant validity, concurrent validity, and practical usefulness at 2 time points (precoronavirus disease 2019 and current). RESULTS: The scale showed excellent reliability (Cronbach's α = 0.95). It had a 4-factor structure that was replicated at the 2 time points. The 4 subscales were moderately correlated (between r = 0.438 and 0.744). The scale showed excellent convergent and discriminatory validity, correlating moderately with State Trait Anxiety Inventory and Generalized Anxiety Disorder, and highly with Food Allergy Quality of Life-Parental Burden. It also showed excellent concurrent validity, differentiating among many external variables. Most importantly, it successfully differentiated parents in need of psychological support for problems related to their child's FA. CONCLUSION: The Impairment Measure for Parental Food Allergy-associated Anxiety and Coping Tool fills a gap in the existing literature as a validated screening tool for parental anxiety associated with a child's FA, employing a multi-factor structure addressing multiple dimensions of anxiety and its functional impacts. It has excellent internal and external validity and is well-suited for use in both research and clinical settings to quickly determine which parents of children with FA are in need of further psychological support.

Elevated Cow's Milk-Specific IgE Levels Prior to Oral Immunotherapy Decrease the Likelihood of Reaching the Maintenance Dose.

BACKGROUND: Food desensitization via oral immunotherapy (OIT) is gaining acceptance in clinical practice. Owing to adverse reactions, the duration of the buildup phase until a maintenance dose is achieved may be prolonged, and in a minority of cases, OIT is stopped. OBJECTIVE: We aimed to assess factors associated with the probability of reaching the maintenance dose in cow's milk (CM) OIT. METHODS: We collected data from patients undergoing CM OIT at the Montreal Children's Hospital, BC Children's Hospital, and Hospital for Sick Children. We compared univariable and multivariable Cox regressions to evaluate sociodemographic factors, comorbidities, clinical characteristics, and biomarkers at study entry associated with the likelihood of reaching a maintenance dose of 200 mL of CM. RESULTS: Among 69 children who reached 4 mL of milk, the median age was 12 years (interquartile range, 9-15 years); 59% were male. Median duration of buildup phase from 4 to 200 mL was 24.0 weeks (interquartile range, 17.7-33.4 weeks). After adjusting for age and sex, higher baseline levels of specific IgE antibodies for α-lactalbumin (hazard ratio [HR] = 0.80; 95% confidence interval [CI], 0.67-0.95), ß-lactoglobulin (HR = 0.86; 95% CI, 0.76-0.98), casein (HR = 0.82; 95% CI, 0.72-0.94), and total CM (HR = 0.79; 95% CI, 0.65-0.97) were associated with a decreased probability of reaching maintenance. In addition, for every 10-mL increase in CM tolerated at entry challenge, the probability of reaching maintenance increased by 10%. CONCLUSIONS: The data suggest that higher levels of CM-specific IgE decreased the likelihood of reaching maintenance, whereas an increased cumulative CM dose at entry challenge increased the likelihood. Assessing these factors before therapy may assist in predicting the success of CM OIT.

The Risk of Allergic Reaction to SARS-CoV-2 Vaccines and Recommended Evaluation and Management: A Systematic Review, Meta-Analysis, GRADE Assessment, and International Consensus Approach.

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.

COVID-19 vaccine testing & administration guidance for allergists/immunologists from the Canadian Society of Allergy and Clinical Immunology (CSACI).

BACKGROUND: Safe and effective vaccines provide the first hope for mitigating the devastating health and economic impacts resulting from coronavirus disease 2019 (COVID-19) and related public health orders. Recent case reports of reactions to COVID-19 vaccines have raised questions about their safety for use in individuals with allergies and those who are immunocompromised. In this document, we aim to address these concerns and provide guidance for allergists/immunologists. METHODS: Scoping review of the literature regarding COVID-19 vaccination, adverse or allergic reactions, and immunocompromise from PubMed over the term of December 2020 to present date. We filtered our search with the terms "human" and "English" and limited the search to the relevant subject age range with the term "adult." Reports resulting from these searches and relevant references cited in those reports were reviewed and cited on the basis of their relevance. RESULTS: Assessment by an allergist is warranted in any individual with a suspected allergy to a COVID-19 vaccine or any of its components. Assessment by an allergist is NOT required for individuals with a history of unrelated allergies, including to allergies to foods, drugs, insect venom or environmental allergens. COVID-19 vaccines should be offered to immunocompromised patients if the benefit is deemed to outweigh any potential risks of vaccination. INTERPRETATION: This review provides the first Canadian guidance regarding assessment of an adolescent and adult with a suspected allergy to one of the COVID-19 vaccines currently available, or any of their known allergenic components, and for patients who are immunocompromised who require vaccination for COVID-19. As information is updated this guidance will be updated accordingly.

Novel Approaches to Food Allergy Management During COVID-19 Inspire Long-Term Change.

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.

Managing Food Allergy in Schools During the COVID-19 Pandemic.

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.

A Phased Approach to Resuming Suspended Allergy/Immunology Clinical Services.

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.

COVID-19: Pandemic Contingency Planning for the Allergy and Immunology Clinic.

In the event of a global infectious pandemic, drastic measures may be needed that limit or require adjustment of ambulatory allergy services. However, no rationale for how to prioritize service shut down and patient care exists. A consensus-based ad-hoc expert panel of allergy/immunology specialists from the United States and Canada developed a service and patient prioritization schematic to temporarily triage allergy/immunology services. Recommendations and feedback were developed iteratively, using an adapted modified Delphi methodology to achieve consensus. During the ongoing pandemic while social distancing is being encouraged, most allergy/immunology care could be postponed/delayed or handled through virtual care. With the exception of many patients with primary immunodeficiency, patients on venom immunotherapy, and patients with asthma of a certain severity, there is limited need for face-to-face visits under such conditions. These suggestions are intended to help provide a logical approach to quickly adjust service to mitigate risk to both medical staff and patients. Importantly, individual community circumstances may be unique and require contextual consideration. The decision to enact any of these measures rests with the judgment of each clinician and individual health care system. Pandemics are unanticipated, and enforced social distancing/quarantining is highly unusual. This expert panel consensus document offers a prioritization rational to help guide decision making when such situations arise and an allergist/immunologist is forced to reduce services or makes the decision on his or her own to do so.