Implications of the non-specific effect induced by Bacillus Calmette-Guerin (BCG) vaccine on vaccine recommendations

Abstract Objectives: Since the beginning of its use for the prevention of tuberculosis (TB) in 1921, other uses of BCG (Bacillus Calmette-Guérin) have been proposed, particularly in the treatment of malignant solid tumors, multiple sclerosis, and other autoimmune diseases. Its beneficial impact on other infections, by nontuberculous mycobacteria, and by viruses, has been more often studied in recent years, especially after the introduction of the concept of trained immunity. The present study's objective was to review the possible indications of BCG and the immunological rationale for these indications. Data source: Non-systematic review carried out in the PubMed, SciELO and Google Scholar databases, using the following search terms: "BCG" and "history", "efficacy", "use", "cancer", "trained immunity", "other infections", "autoimmune diseases". Data synthesis: There is epidemiological evidence that BCG can reduce overall child morbidity/mortality beyond what would be expected from TB control. BCG is able to promote cross-immunity with nontuberculous mycobacteria and other bacteria. BCG promotes in vitro changes that increase innate immune response to other infections, mainly viral ones, through mechanisms known as trained immunity. Effects on cancer, except bladder cancer, and on autoimmune and allergic diseases are debatable. Conclusions: Despite evidence obtained from in vitro studies, and some epidemiological and clinical evidence, more robust evidence of in vivo efficacy is still needed to justify the use of BCG in clinical practice, in addition to what is recommended by the National Immunization Program for TB prevention and bladder cancer treatment.

Allergic rhinitis and sleep disorders in children - coexistence and reciprocal interactions

Abstract Objective To review, critically analyze and synthesize knowledge from the international literature regarding the association between allergic rhinitis (AR) and sleep disorders, the impact of AR treatment on children's sleep, and lay the foundation for future research on this topic. Source of data A literature search using PubMed database including original and review articles, systematic reviews and meta-analyses using keywords related to AR, sleep disorders and sleep-disordered breathing. Synthesis of data Sleep is fundamental to health, and its assessment and control of conditions that trigger or aggravate disturbances are of the uttermost importance. Allergic rhinitis (AR) is common in children and may interfere with both their quality of life and quality of sleep. It has emerged as one of the most important risk factors for habitual snoring in children and appeared to increase the risk of Obstructive Sleep Apnea (OSA), with AR severity exhibiting a significant and independent association with pediatric OSA severity. However, in some studies, those associations between AR and OSA in children are not very consistent. Conclusions A substantial level of controversy exists regarding the interactions between AR and OSA in children. Notwithstanding, identifying and treating AR in clinical settings is probably an important step toward improving symptoms and preventing deterioration of sleep quality in children and may improve the severity of underlying OSA. Considering the high prevalence, morbidity, economic and social implications of both AR and sleep problems, it is crucial that healthcare providers improve their understanding of the relationships between those conditions among children.

Diretrizes brasileiras do angioedema hereditário 2022 ­ Parte 1: definição, classificação e diagnóstico / 2022 Brazilian guidelines for hereditary angioedema ­ Part 1: definition, classification, and diagnosis

O angioedema hereditário é uma doença autossômica dominante caracterizada por crises recorrentes de edema que acometem o tecido subcutâneo e o submucoso, com envolvimento de diversos órgãos. Os principais locais afetados são face, membros superiores e inferiores, as alças intestinais e as vias respiratórias superiores. Em decorrência da falta de conhecimento dessa condição por profissionais de saúde, ocorre atraso importante no seu diagnóstico, comprometendo a qualidade de vida dos indivíduos afetados. Além disso, o retardo no diagnóstico pode resultar em aumento da mortalidade por asfixia devido ao edema de laringe. A natureza errática das crises com variação do quadro clínico e gravidade dos sintomas entre diferentes pacientes, e no mesmo paciente ao longo da vida, se constitui em desafio no cuidado dos doentes que têm angioedema hereditário. O principal tipo de angioedema hereditário é resultante de mais de 700 variantes patogênicas do gene SERPING1 com deficiência funcional ou quantitativa da proteína inibidor de C1, porém nos últimos anos outras mutações foram descritas em seis outros genes. Ocorreram avanços importantes na fisiopatologia da doença e novas drogas para o tratamento do angioedema hereditário foram desenvolvidas. Nesse contexto, o Grupo de Estudos Brasileiro em Angioedema Hereditário (GEBRAEH) em conjunto com a Associação Brasileira de Alergia e Imunologia (ASBAI) atualizou as diretrizes brasileiras do angioedema hereditário. O maior conhecimento dos diversos aspectos resultou na divisão das diretrizes em duas partes, sendo nessa primeira parte abordados a definição, a classificação e o diagnóstico.

Hereditary angioedema is an autosomal dominant disease characterized by recurrent attacks of edema that affect the subcutaneous tissue and the submucosa, involving several organs. The main affected sites are the face, upper and lower limbs, gastrointestinal tract, and upper airways. Because health professionals lack knowledge about this condition, there is a significant delay in diagnosis, compromising the quality of life of affected individuals. Furthermore, delayed diagnosis may result in increased mortality from asphyxia due to laryngeal edema. The erratic nature of the attacks with variations in clinical course and severity of symptoms among different patients and in one patient throughout life constitutes a challenge in the care of patients with hereditary angioedema. The main type of hereditary angioedema results from more than 700 pathogenic variants of the SERPING1 gene with functional or quantitative deficiency of the C1 inhibitor protein, but in recent years other mutations have been described in six other genes. Important advances have been made in the pathophysiology of the disease, and new drugs for the treatment of hereditary angioedema have been developed. In this context, the Brazilian Study Group on Hereditary Angioedema (GEBRAEH) in conjunction with the Brazilian Association of Allergy and Immunology (ASBAI) updated the Brazilian guidelines on hereditary angioedema. Greater knowledge of different aspects resulted in the division of the guidelines into two parts, with definition, classification, and diagnosis being addressed in this first part.

Diretrizes brasileiras de angioedema hereditário 2022 ­ Parte 2: terapêutica / 2022 Brazilian guidelines for hereditary angioedema ­ Part 2: therapy

O tratamento do angioedema hereditário tem início com a educação dos pacientes e familiares sobre a doença, pois é fundamental o conhecimento da imprevisibilidade das crises, assim como os seus fatores desencadeantes. O tratamento medicamentoso se divide em terapia das crises e profilaxia das manifestações clínicas. As crises devem ser tratadas o mais precocemente possível com o uso do antagonista do receptor de bradicinina, o icatibanto ou o concentrado de C1-inibidor. É necessário estabeler um plano de ação em caso de crises para todos os pacientes. A profilaxia de longo prazo dos sintomas deve ser realizada preferencialmente com medicamentos de primeira linha, como concentrado do C1-inibidor ou o anticorpo monoclonal anti-calicreína, lanadelumabe. Como segunda linha de tratamento temos os andrógenos atenuados. Na profilaxia de curto prazo, antes de procedimentos que podem desencadear crises, o uso do concentrado de C1-inibidor é preconizado. Existem algumas restrições para uso desses tratamentos em crianças e gestantes que devem ser consideradas. Novos medicamentos baseados nos avanços do conhecimento da fisiopatologia do angioedema hereditário estão em desenvolvimento, devendo melhorar a qualidade de vida dos pacientes. O uso de ferramentas padronizadas para monitorização da qualidade de vida, do controle e da atividade da doença são fundamentais no acompanhamento destes pacientes. A criação de associações de pacientes e familiares de pacientes com angioedema hereditário tem desempenhado um papel muito importante no cuidado destes pacientes no nosso país.

The treatment of hereditary angioedema begins with the education of patients and their families about the disease, as it is essential to know the unpredictability of attacks as well as their triggering factors. Drug treatment is divided into attack therapy and prophylaxis of clinical manifestations. Attacks should be treated as early as possible with the bradykinin receptor antagonist icatibant or C1-inhibitor concentrate. An action plan needs to be established for all patients with attacks. Long-term prophylaxis of symptoms should preferably be performed with first-line drugs such as C1-inhibitor concentrate or the anti-kallikrein monoclonal antibody lanadelumab. Attenuated androgens are the second line of treatment. In short-term prophylaxis, before procedures that can trigger attacks, the use of C1-inhibitor concentrate is recommended. There are some restrictions for the use of these treatments in children and pregnant women that should be considered. New drugs based on advances in knowledge of the pathophysiology of hereditary angioedema are under development and are expected to improve patient quality of life. The use of standardized tools for monitoring quality of life and controlling disease activity is essential in the follow-up of these patients. The creation of associations of patients and families of patients with hereditary angioedema has played a very important role in the care of these patients in Brazil.

Posicionamento da ASBAI sobre a vacinação de crianças de 5 a 11 anos contra a COVID-19 com a vacina Comirnaty/ Pfizer/BioNTech ­ 27/12/2021 / ASBAI's position on vaccination of children aged 5 to 11 years against COVID-19 with the Comirnaty/Pfizer/BioNTech vaccine ­ 12/27/2021

A Associação Brasileira de Alergia e Imunologia (ASBAI) se manifesta totalmente favorável à imunização contra a COVID-19 em indivíduos entre 5 e 11 anos, para a proteção não somente deste grupo, mas também de seus conviventes. A vacinação de crianças, demonstrada sua eficácia e segurança, é fundamental para o controle da circulação do vírus e proteção de indivíduos cuja resposta vacinal pode não ocorrer de modo eficiente, como os imunocomprometidos e idosos. A imunização de pessoas entre 5 e 11 anos deve ser uma estratégia de saúde pública fundamental para o controle da pandemia que nos assola desde março de 2020 com todas as suas graves consequências para a saúde pública e a economia.

The Brazilian Association of Allergy and Immunology (ASBAI) is totally in favor of immunization against COVID-19 in individuals between 5 and 11 years old, for the protection not only of this group, but also of their cohabitants. The vaccination of children, once its efficacy and safety has been demonstrated, is essential for controlling the circulation of the virus and protecting individuals whose vaccine response may not occur efficiently, such as the immunocompromised and the elderly. The immunization of people between the ages of 5 and 11 must be a fundamental public health strategy to control the pandemic that has been plaguing us since March 2020 with all its serious consequences for public health and the economy.

Allergic sensitization pattern of patients in Brazil

Abstract Objective Allergic sensitization is one of the key components for the development of allergies. Polysensitization seems to be related to the persistence and severity of allergic diseases. Furthermore, allergic sensitization has a predictive role in the development of allergies. The aim of this study was to characterize the pattern of sensitization of atopic patients treated at different pediatric allergy referral centers in Brazil. Methods A nation-wide transversal multicenter study collected data on patients attended in Brazil. Peripheral blood samples were collected to determine the serum levels of allergen-specific IgE. If allergen-specific IgE was higher than 0.1 kUA/L, the following specific components were quantified. Results A total of 470 individuals were enrolled in the study. Mite sensitization was the most frequent kind in all participants. A high frequency of sensitization to furry animals and grasses featured in the respiratory allergies. Regarding components, there was a predominance of sensitization to Der p 1 and Der p 2. It has been verified that having a food allergy, atopic dermatitis, or multimorbidity are risk factors for the development of more severe allergic disease. Conclusion Studies on the pattern of allergic sensitization to a specific population offer tools for the more effectual prevention, diagnosis, and treatment of allergic diseases. Sensitization to dust mites house was the most prevalent in the evaluated sample. High rates of sensitization to furry animals also stand out. Patients with food allergy, atopic dermatitis, or multimorbidity appear to be at greater risk for developing more severe allergic diseases.

Vacinas COVID-19 e outros imunobiológicos ­ intervalos preconizados / COVID-19 vaccines and other immunobiological drugs ­ recommended intervals

Com o início do programa de vacinação contra a COVID-19 no Brasil, surgiu uma série de questionamentos relacionados ao uso dos imunizantes. Neste documento, o grupo de estudo da COVID-19 da Associação Brasileira de Alergia e Imunologia (ASBAI) avalia as evidências científicas e se posiciona em relação aos intervalos preconizados entre a administração das vacinas contra o SARS-CoV-2 e dos imunobiológicos.

With the beginning of the COVID-19 vaccination program in Brazil, a series of questions related to the use of vaccines arose. In this document, the COVID-19 study group of the Brazilian Association of Allergy and Immunology (ASBAI) assesses the scientific evidence and takes a stand for the recommended intervals between the administration of SARS-CoV-2 vaccines and that of immunobiological drugs.

Reinfecções pelo SARS-CoV-2: fato ou fake ? Implicações para a resposta vacinal / Reinfection with SARS-CoV-2: fact or fake? Implications for vaccine response

Há evidências atuais de que a reinfecção pelo SARS-CoV-2 é uma realidade, mas na grande maioria das situações não houve investigação que permitisse sua perfeita caracterização, sendo confirmados poucos casos. Em situações de real reinfecção, esta ocorreu, em sua grande maioria, por variantes do vírus, com diversas mutações, usualmente na proteína da espícula viral, em profissionais de saúde altamente expostos, ou em portadores de imunodeficiências, tanto primárias quanto secundárias. Ressaltamos que as vacinas podem ser modificadas com relativa facilidade, mas a capacidade de fabricação e de distribuição pelo mundo será capaz de acompanhar a demanda por vacinação em massa de forma eficiente? Neste manuscrito, a comissão de estudo da COVID-19 da ASBAI analisa criticamente o conhecimento atual sobre a reinfecção pelo SARS-CoV-2.

There is current evidence that reinfection with SARS-CoV-2 is a reality, but there is also a lack of investigation that would allow its perfect characterization, and few cases have been confirmed. Real reinfections occurred mostly with variants of the virus, with several mutations, usually in the viral spike protein, in highly exposed health professionals or in patients with immunodeficiencies, both primary and secondary. We emphasize that vaccines can be modified relatively easily, but will the manufacturing and distribution capacity around the world be able to keep up with the demand for mass vaccination efficiently? The ASBAI COVID-19 study commission critically analyzes in this manuscript the current knowledge about SARS-CoV-2 reinfection.

Alergias e vacinas contra a COVID-19 / Allergies and vaccines against COVID-19

As vacinas são reconhecidas como uma das conquistas do século passado de maior impacto em Saúde Pública, reduzindo de modo significativo a morbidade e mortalidade associadas a grande número de doenças infecciosas. No entanto, em casos raros, as vacinas podem causar doença ou eventos adversos pós-vacinação (EAPV). Os imunologistas clínicos e alergistas possuem um papel muito importante nesse momento em que mundialmente buscamos imunizar a população contra a COVID- 19. Eles devem fornecer apoio aos indivíduos orientando sobre o diagnóstico e tratamento de EAPV, incluindo anafilaxia, e, ainda, apoiar e encorajar os pacientes a se vacinarem, mesmo após eventos adversos, desde que leves ou moderados.

Vaccines are known as one of the achievements of the last century with greatest impact on public health, significantly reducing morbidity and mortality associated with a large number of infectious diseases. However, in rare cases, vaccines may cause disease or adverse events following immunization. Clinical immunologists and allergists have a very important role in the worldwide vaccination against COVID-19. They should provide support to individuals by advising on the diagnosis and treatment of adverse events following immunization, including anaphylaxis, and also support and encourage patients to be vaccinated, even after adverse events, as long as they are mild or moderate.

Vacinas contra a COVID-19 e os erros inatos da imunidade (ou imunodeficiências primárias) / COVID-19 vaccines and inborn errors of immunity (or primary immunodeficiencies)

Desde o início da pandemia de COVID-19 iniciou-se a corrida por uma imunização ativa, eficaz e segura. Todas as vacinas desenvolvidas até o momento vêm demostrando boa eficácia na prevenção de casos graves de COVID-19, de hospitalizações e mortes. Muitos pacientes com erros inatos da imunidade (EII) não terão capacidade de desenvolver uma resposta imune semelhante ao indivíduo imunocompetente. Esses pacientes foram incluídos nos grupos prioritários definidos pelo Ministério da Saúde, como pessoas entre 18 a 59 anos com uma ou mais das comorbidades, incluindo as imunodeficiências primárias. Eles podem e devem receber as vacinas em uso contra o SARS-CoV-2, mas nem sempre apresentarão uma resposta imunológica satisfatória e protetora, e, portanto, seus contactantes também devem ser vacinados.

Since the beginning of the COVID-19 pandemic, the race for an active, effective, and safe immunization has started. All vaccines developed to date have shown good efficacy in preventing serious cases of COVID-19, hospitalization, and death. Many patients with inborn errors of immunity will not be able to develop an immune response similar to that of immunocompetent individuals. These patients were included in the priority groups defined by the Brazilian Ministry of Health, as people between 18 and 59 years of age with one or more comorbidities, including primary immunodeficiencies. They can and should receive the vaccines in use against SARS-CoV-2, but they will not always have a satisfactory and protective immune response, and, therefore, those in direct contact with them should also be vaccinated.

Imunizações em pacientes com doenças raras ­ Posicionamento conjunto da Sociedade Brasileira de Imunizações (SBIm), Associação Brasileira de Alergia e Imunologia (ASBAI) e Sociedade Brasileira de Pediatria (SBP) / Immunizations in patients with rare diseases ­ A joint position statement of the Brazilian Society of Immunizations (SBIm), Brazilian Association of Allergy and Immunology (ASBAI), and Brazilian Society of Pediatrics (SBP)

Introdução: De acordo com a Organização Mundial da Saúde, a prevalência de doenças raras (abaixo de 65 casos/100.000 habitantes) é de 6%, e variável na dependência da população em estudo. Há 6.172 doenças raras (DR) catalogadas. Esquemas vacinais específicos para DR não estão disponíveis no Brasil, e esta orientação é limitada na maioria dos países. Objetivos: Identificar e propor esquemas específicos de imunização para pacientes com DR, tendo-se em conta segurança e eficácia. Fonte de dados: Revisão não sistemática da literatura, com busca de artigos de 2000 a 2020 no PubMed, Google Scholar, SciELO e Orphanet usando os termos "rare diseases" ou "inborn errors of metabolism" ou "cystic fibrosis" ou "inborn errors of immunity" e "vaccines" ou "immunization" ou "vaccination", nos idiomas inglês, francês, espanhol e português. Conclusões: A imunização de pessoas com DR é tema complexo, com poucas recomendações publicadas a este respeito, e na maioria das vezes realizada de modo empírico. É importante que a equipe médica que acompanha esses pacientes tenha um olhar abrangente e proporcione a prevenção mais completa possível.

Background: According to the World Health Organization, the prevalence of rare diseases (below 65 cases/100 000 population) is 6% and may vary depending on the study population. There are 6172 rare diseases (RD) listed. RD-specific vaccine schemes are not available in Brazil, and guidance is limited in most countries. Objectives: To identify and propose specific immunization schemes for RD patients, valuing safety and efficacy. Data source: A nonsystematic literature review was conducted, with search for articles from 2000 to 2020 on PubMed, Google Scholar, SciELO, and Orphanet with the terms "rare diseases" or "inborn errors of metabolism" or "cystic fibrosis" or "inborn errors of immunity" and "vaccines" or "immunization" or "vaccination," in English, French, Spanish, and Portuguese languages. Conclusions: Immunization of RD patients is a complex topic with few published recommendations, most often produced empirically. The medical teams following up these patients should have a more comprehensive insight and provide the most complete prevention possible.

Evolução da infecção por COVID-19 em um grupo de pacientes com erros inatos da imunidade / Evolution of a Brazilian group of patients with inborn errors of immunity with COVID-19

Introdução: O novo coronavírus causou uma pandemia e desafio na saúde pública em todo o mundo. Até hoje muitos mecanismos do vírus no hospedeiro foram desvendados, cujo conhecimento é essencial para entender a evolução clínica e desenvolver uma estratégia de terapia adequada para a infecção com COVID-19. Contudo, pouco se sabe da infecção por COVID-19 em pacientes com erros inatos da imunidade (EII), principalmente em pacientes com síndromes autoinflamatórias. Objetivo: Descrever a evolução de pacientes com erros inatos da imunidade acometidos por SARS-CoV-2 em um centro de referência em doenças raras e da imunidade no Brasil. Material e métodos: Foram analisados retrospectivamente dados clínicos, radiológicos, patológicos e laboratoriais de pacientes com erros inatos da imunidade infectados por SARS-CoV-2 de março a dezembro de 2020. Resultados: Ao total, dados de 13 pacientes com diversos EII foram coletados para descrever tanto a evolução da doença quanto para buscar mais conhecimento sobre o tratamento desses pacientes. Em nenhum paciente a síndrome da angústia respiratória aguda foi observada, e também não foi observado nenhum óbito. A grande maioria dos pacientes teve evolução com síndrome gripal. Observou-se, em um paciente com CAPS-NLRP3, rash cutâneo vasculítico responsivo ao uso de anti-IL1. Conclusão: Neste pequeno grupo de pacientes com erros inatos da imunidade e com infecção por SARS-CoV-2, o risco de fatalidade foi menor do que observado na literatura. Especialmente, o fato de que a maioria apresenta maior predisposição a inflamação do que infecção deve ser levada em conta na análise dos dados finais. Reportamos pela primeira vez a presença de urticária vasculítica em paciente com CAPS, que habitualmente apresentam-se com urticária neutrofílica. Tal achado ressalta a capacidade de injúria vascular do vírus, mesmo em indivíduos predispostos geneticamente.

Introduction: The pandemic caused by the new coronavirus has become a global public health challenge. To date, many pathophysiological mechanisms of the virus have been explained, which is essential to understand clinical evolution and to develop appropriate therapeutic strategies for patients with COVID-19. However, less is known about COVID-19 in patients with inborn errors of immunity (IEI), especially in those with autoinflammatory disorders. Objective: To report the natural evolution of a group of patients with IEI infected with SARS-CoV-2 treated at a center of excellence in rare diseases and immunity in Brazil. Material and methods: Clinical, radiological, pathological, and laboratory data of patients treated from March to December 2020 were retrospectively retrieved and analyzed. Results: Data of 13 patients with IEI were collected to describe the natural course of the infection with SARS-CoV-2 and to enhance understanding of treatment for these patients. Neither acute respiratory distress syndrome nor death were observed. The vast majority of patients had flu-like symptoms. Urticarial vasculitis was observed in one patient with CAPS-NLRP3 responsive to the use of anti-IL1. Conclusion: In this small group of patients with IEI and SARSCoV- 2 infection, fatality risk was lower than that observed in the literature. Importantly, the fact that our group is composed mainly of patients with predisposition to inflammation instead of infection should be taken into account for final data analysis. Furthermore, we observed for the first time the presence of urticarial vasculitis in a patient with CAPS, which is usually characterized by neutrophilic urticaria. Such finding reinforces the virus ability to cause vascular injury, even in individuals with a genetic predisposition.

Laboratory diagnosis of COVID-19

Abstract Objectives: This was a non-systematic review of the literature on the laboratory diagnosis of COVID-19. Data sources: Searches in PubMed and Google Scholar for articles made available in 2020, using the terms "diagnosis" OR "diagnostic" OR "diagnostic tests" OR "tests" AND "COVID-19" OR "SARS-CoV-2" in the title. Summary of findings: Tests for the etiological agent identify genetic material of SARS-CoV-2 or humoral responses to it. The gold standard for diagnosis is the identification of viral genome targets by real-time polymerase chain reaction (RT-PCR) in respiratory tract materials during the first week of symptoms. Serological tests should be indicated from the second week of symptoms onwards. A wide range of different tests is available, with variable sensitivity and specificity, most of which require validation. Laboratory tests such as complete blood count, C-reactive protein (CRP), D-dimer, clotting tests, lactic dehydrogenase (LDH), ferritin, and procalcitonin identify risk of disease with greater severity, thromboembolic complications, myocardial damage, and/or worse prognosis. Imaging tests may be useful for diagnosis, especially when there is a compatible clinical picture, and other tests presented negative results or were unavailable. Conclusions: The identification of genetic material of the virus by RT-PCR is the gold standard test, but its sensitivity is not satisfactory. The diagnosis of COVID-19 should be based on clinical data, epidemiological history, tests for etiological diagnosis, and tests to support the diagnosis of the disease and/or its complications. New diagnostic methods with higher sensitivity and specificity, as well as faster results, are necessary.

Vacinas COVID-19 e reações imunoalérgicas / COVID-19 vaccines and immunoallergic reactions

A avaliação dos riscos e benefícios deve ser realizada para qualquer intervenção preventiva, diagnóstica ou terapêutica em Medicina. As vacinas, assim como qualquer imunobiológico, são consagradas pelas inúmeras vantagens inerentes à proteção da saúde, apesar dos potenciais riscos de eventos adversos que, na imensa maioria das vezes, são raros, leves e controláveis. O desenvolvimento de vacinas contra o novo SARS-CoV-2 representa um dos principais anseios da população mundial e representa extraordinário avanço da Ciência. Pacientes com histórico de alergias graves a algum componente das vacinas ou a uma dose prévia de alguma delas, devem ser avaliados com cautela pelo especialista para decidir se esta deverá ser contraindicada, aplicada com supervisão médica, ou se estará indicado protocolo de dessensibilização.

The assessment of risks and benefits must be carried out for any preventive, diagnostic, or therapeutic intervention in medicine. Vaccines, like any biologic, are recognized for the innumerable advantages in public health, despite the potential risks of adverse events that, in the vast majority of cases, are rare, mild, and controllable. The development of vaccines against the new SARSCoV- 2 represents one of the main wishes of the world population as well as an extraordinary advance in science. Patients with a history of severe allergies to any component of the vaccines or reaction to a previous dose of any of them should be carefully evaluated by the specialist to decide whether vaccination should be contraindicated or administered with medical supervision, or if a desensitization protocol will be indicated.