Immunogenicity and reactogenicity of heterologous immunization schedules with COVID-19 vaccines: a systematic review and network meta-analysis / 中华医学杂志(英文版)

BACKGROUND@#Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent. This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.@*METHODS@#Multiple databases with relevant studies were searched with an end date of October 31, 2021, and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31, 2022. Randomized controlled trials (RCTs) that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed. Primary outcomes included neutralizing antibodies against the original strain and serious adverse events (SAEs). A network meta-analysis (NMA) was conducted using a random-effects model.@*RESULTS@#In all, 11 RCTs were included in the systematic review, and nine were ultimately included in the NMA. Among participants who received two doses of CoronaVac, another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit (SU); a dose of BNT162b2 induced the highest geometric mean ratio (GMR) of 15.24, 95% confidence interval [CI]: 9.53-24.39. Following one dose of BNT162b2 vaccination, a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone (GMR = 1.32; 95% CI: 1.06-1.64), NVX-CoV2373 (GMR = 1.60; 95% CI: 1.16-2.21), or ChAdOx1 (GMR = 1.80; 95% CI: 1.25-2.59). Following one dose of ChAdOx1, a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1 (GMR = 11.09; 95% CI: 8.36-14.71) or NVX-CoV2373 (GMR = 2.87; 95% CI: 1.08-3.91). No significant difference in the risk for SAEs was found in any comparisons.@*CONCLUSIONS@#Relative to vaccination with two doses of CoronaVac, a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines. For primary vaccination, schedules including mRNA vaccines induce a greater immune response. However, the comparatively higher risk for local and systemic adverse events introduced by mRNA vaccines should be noted.@*REGISTRATION@#PROSPERO; https://www.crd.york.ac.uk/PROSPERO/ ; No. CRD42021278149.

Tiroiditis subaguda posterior a la administración de la vacuna COVID-19. Presentación de tres casos clínicos / Subacute thyroiditis following COVID-19 vaccine administration. Presentation of three clinical cases

La tiroiditis subaguda (TSA) es un trastorno inflamatorio autolimitado de la glándula tiroides. Es más común en mujeres y se caracteriza por dolor cervical, síntomas inflamatorios sistémicos y disfunción tiroidea. La TSA se ha asociado a una infección viral previa, generalmente respiratoria o enteral. Múltiples virus se han relacionado con TSA. Desde mayo de 2020 se reportaron casos de TSA relacionados con la infección por SARS-CoV-2. Describimos 3 casos de SAT después de la vacuna COVID-19. Dos casos fueron inoculados con vacuna SARS-CoV-2 inactivada (CoronaVac) y uno con vacuna de ARNm Pfizer-BioNTech. Los síntomas clínicos comenzaron pocas semanas después de la inoculación. Presentaron dolor cervical anterior, fiebre, astenia y tirotoxicosis transitoria. En todos los casos la evolución fue favorable. Hasta donde sabemos, estos son los primeros casos de SAT posteriores a la vacuna COVID-19 descritos en Chile.

Subacute thyroiditis (SAT) is a self-limited inflammatory disorder of the thyroid gland. The disease is more common in women and is characterized by neck pain, systemic symptoms, and thyroid dysfunction. SAT It has been associated with viral, respiratory or enteral infection. Multiple viruses had been related to SAT. Since May 2020, cases of SAT related to SARS-CoV-2 infection were reported. We describe 3 cases of SAT following COVID-19 vaccine. Two cases were inoculated with inactivated SARS-CoV-2 vaccine (CoronaVac) and one with mRNA vaccine Pfizer­BioNTech. The clinical symptoms began few weeks after inoculation. They presented with neck pain, fever, general malaise and transient thyrotoxicosis. All cases revered spontaneously. To our knowledge, these are the first cases of SAT following COVID-19 vaccine described in Chile.

Seroconversión posterior a la aplicación de vacuna Pfizer anticovid-19 en personal de la salud / Seroconversión rates following covid-19 Pfizer vaccine application among health personnel

Introducción: la pandemia por COVID-19 constituyó un problema de salud que requirió la realización de esfuerzos sin precedentes para la fabricación de vacunas en tiempo récord. Dada la emergencia no se podían llevar a cabo los protocolos establecidos que componen la fármacovigilancia, razón por la cual es importante realizar estudios locales que contribuyan al conocimiento y vigilancia clínica y farmacológica. Objetivos: evaluar los niveles de anticuerpos desarrollados en quienes recibieron la vacuna Pfizer, determinar los efectos secundarios más frecuentes y describir la mortalidad por todas las causas a un año en este grupo. Métodos: estudio prospectivo, de corte transversal de una cohorte de 105 pacientes, se realizó estadística descriptiva en el análisis univariado y bivariado para los niveles de anticuerpos, se describe la correlación de la edad con los niveles de anticuerpos y la mortalidad cruda de los pacientes a 1 año. Resultados: la edad media de los 105 pacientes fue 36,45 años (DE 10,11), con tendencia al aumento de los niveles de anticuerpos en la segunda toma y descenso en la tercera; se encontró una correlación negativa significativa entre edad y niveles de anticuerpos en la segunda toma. Conclusiones: en los sujetos más jóvenes se presentaron mayores títulos de anticuerpos que disminuyeron con el tiempo, la variabilidad en la titulación puede depender de varios factores como edad, género, imnunosupresores y comorbilidades. Es necesaria la medición para realizar una vacunación periódica e individualizarla. La mortalidad a un año fue de 0%.

Introduction: the COVID-19 pandemic prompted unprecedented efforts to manufacture vaccines in record time. Given the emergency, to conduct the established pharmacovigilance protocols was not possible, thus, the importance of carrying out local studies which contribute to gain understanding and clinical and pharmacological surveillance. Objectives: to evaluate antibody levels developed in subjects who received the Pfizer vaccine; to determine the most frequent side effects; and describe all-cause 1-year mortality in this group. Methods: a prospective, cross-sectional study in a cohort of 105 patients. Descriptive statistics were conducted by univariate and bivariate analyses of antibody levels. The correlation between age and antibody levels and the crude 1-year mortality rate among patients is described. Results: mean age was 36.45 years (SD 10.11), with a tendency for antibody levels to increase with the second dose and decrease with the third dose. A significant negative correlation was found between age and antibody levels in the second dose. Conclusions: younger subjects had higher antibody titers, which decreased over time. The variability of titer estimates may depend on several factors such as, age, gender, immunosuppressive therapies and comorbidities. Measurements are essential for periodic and individualized vaccination. One-year mortality rate was 0%.

Infección por SARS - CoV-2 posterior a la inmunización artificial e híbrida en el personal de salud / SARS-CoV-2 breakthrough infection after artificial and hybrid immunization in healthcare workers

Reportes actuales sugieren que el antecedente de infección por SARS - CoV-2 y completar un esquema de vacunación otorga mayor protección contra la presentación sintomática de COVID -19. Se comparó el riesgo de enfermar de COVID -19 entre el personal de salud con esquema completo de vacuna contra SARS - CoV-2 BNT162b2 y el antecedente de infección por SARS - CoV-2. Estudio de cohorte histórica en 1874 trabajadores de la salud del Nuevo Hospital Civil de Guadalajara inmunizados con la vacuna BNT162b2 entre enero y marzo de 2021. Después de seis meses de seguimiento, el grupo de no expuestos (sin antecedente de infección) fue de 1397 y el grupo expuesto (con antecedente de infección), de 477 sujetos. La incidencia de infección por SARS - CoV-2 fue de 39 casos. El riesgo de infección en la cohorte posterior a la inmunización fue de 0,021. El grupo de inmunización híbrida presentó un riesgo menor de infección comparado con el grupo de inmunización artificial (0,015 y 0,243). La inmunización híbrida contribuyó a una reducción del riesgo atribuible a la población de 0,003 (R0 0,024; Rp 0,020). La hospitalización se presentó en el 7,69 % de los casos confirmados con SARS - CoV-2. El riesgo de hospitalización en inmunización híbrida es de 0,210 y de 0,143 en el grupo de inmunización artificial (RR 1,46 IC95 % 0,13 -16,11). Se llegó a la conclusión que la inmunización híbrida podría contribuir a reducir el riesgo de infección por SARS - CoV-2, potenciando la inmunidad generada por la vacuna contra COVID -19

Current reports suggest that a history of SARS - CoV-2 infection and completing a vaccination schedule provides greater protection against the symptomatic presentation of COVID -19. The risk of becoming ill with COVID -19 was compared between health personnel with a complete SARS - CoV-2 BNT162b2 vaccine schedule and a history of SARS - CoV-2 infection. Historical cohort study in 1874 health workers of the New Civil Hospital of Guadalajara immunized with the BNT162b2 vaccine between January and March 2021. After six months of follow-up, the non-exposed group (without a history of infection) was 1397 and the exposed group (with a history of infection), of 477 subjects. The incidence of SARS - CoV-2 infection was 39 cases. The risk of infection in the post-immunization cohort was 0.021. The hybrid immunization group had a lower risk of infection compared to the artificial immunization group (0.015 and 0.243). Hybrid immunization contributed to a population-attributable risk reduction of 0.003 (R0 0.024, Rp 0.020). Hospitalization occurred in 7.69% of confirmed cases with SARS - CoV-2. The risk of hospitalization in hybrid immunization is 0.210 and 0.143 in the artificial immunization group (RR 1.46 CI95% 0.13 -16.11). It was concluded that hybrid immunization could help reduce the risk of SARS - CoV-2 infection, enhancing the immunity generated by the vaccine against COVID -19

Linfadenopatía cervical y supraclavicular ipsilateral a la vacunación de refuerzo con Pfizer-BioNTech COVID-19 / Cervical and supraclavicular lymphadenopathy after Pfizer-BioNTech COVID-19 vaccination

La COVID-19 es la enfermedad causada por el nuevo coronavirus conocido como SARS-CoV-2. Para finales del 2020, la FDA de los Estados Unidos aprobó la primera vacuna para su uso de emergencia contra el COVID-19, desarrollada por Pfizer y BioNTech (BNT162b2). Este nuevo tipo de vacuna utiliza ARN mensajero modificado, el cual le da instrucciones al organismo para generar un fragmento de la proteína espiga de la superficie del virus, y que por sí sola desencadena una respuesta inmunitaria que ayuda a proteger el organismo contra una infección por COVID-19. Dentro de los eventos adversos menos comunes reportados en los estudios clínicos iniciales está la linfadenopatía (0.3 %). Objetivo: reportar el caso de paciente masculino que acude a evaluación sonográfica por preocupación de nódulo palpable en región supraclavicular. Resultados: a la evaluación sonográfica se observa cadena ganglionar reactiva compatible con una linfadenopatía. Paciente reporta vacunación de refuerzo con la vacuna Pfizer 8 días antes de la evaluación, subsecuente a dos vacunas Coronavac, corroborando de que se trata de una linfadenopatía reactiva, secundaria a una respuesta inmune robusta al refuerzo con la vacuna Pfizer. Se realiza una medición de Anti-SARS-CoV-2 TrimericS IgG cuantitativa a los 15 días del refuerzo con Pfizer, reportando valores elevados de 10,600 BAU/mL. Se orientó al paciente a regresar en una semana para seguimiento ecográfico, el cual evidenció resolución espontánea sin secuelas. Conclusiones: los hallazgos de adenopatía axilar o supraclavicular unilateral subsecuentes a la vacunación por COVID-19 deben ser informados tanto a médicos como pacientes, como un efecto secundario temporal producto de la respuesta inmunológica post vacuna. Este hallazgo benigno no requiere seguimiento adicional de imágenes y mucho menos de procedimientos invasivos como biopsias, los cuales generan mucha ansiedad al paciente, además de ser muy costosos para los mismos

COVID-19 is a disease caused by a new coronavirus identified as SARS-CoV-2. Towards the end of 2020, the FDA of the United States approved the first vaccine for emergency use against COVID-19, which was developed by Pfizer and BioNTech (BNT162b2). This new type of vaccine uses a modified RNA Messenger, which gives instructions to the host cells of the vaccinated person to produce a fragment of the spike protein of the virus, which then generates an inmune response and protects the recipient of the vaccine against COVID-19. Among the adverse events less frequently reported in the initial clinical studies of the vaccine is lymphadenopathy which was reported by 0.3% of the participants. Objective: Presentation of a case report of a male subject that came to a ultrasound evaluation due to concern of a palpable nodule in the supraclavicular región. Results: Ultrasound exam showed reactive unilateral cervical and supraclavicular lymphadenopathy. Patient reports a third dose booster with the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine, 8 days prior to the evaluation, after completing a two-dose vaccination schedule with the Coronavac/Sinovac vaccine, confirming a vigorous immune response to the mRNA anti-COVID vaccines. This response was validated by elevated Anti-SARS-CoV-2 TrimericS IgG (10,600 BAU/mL). Patient was informed to return in a week for an echography follow-up which showed spontaneous resolution without leaving sequelae. Conclusions: It is of great importance to inform this benign finding of supraclavicular or axillar adenopathy subsequent to COVID vaccination to the medical community and patients, to avoid unnecessary medical interventions such as imaging or biopsies, which generate anxiety to the patient as well as additional costs

Parálisis de Bell secundaria a vacuna Pfizer para COVID-19: reporte de caso / Bell's Palsy Secondary to COVID-19 Vaccine Pfizer: Case report

Introducción: la BNT162b2 (Pfizer-BioNTech) es una vacuna de ARNm modificado con nucleósidos y formulada con nanopartículas lipídicas para la prevención de la enfermedad covid-19 causada por la infección por SARS-CoV-2. A principios de diciembre del 2020, la BNT162b2 recibió una autorización para su uso de emergencia. Se han publicado datos iniciales de eficacia y seguridad, sin embargo las hojas de información para el consumidor/paciente para vacunas distribuidas en América del Norte no advierten sobre la parálisis de Bell como un posible efecto adverso. Informamos el caso de una mujer que desarrolló parálisis de Bell posterior a la aplicación de la primera dosis de la vacuna Pfizer-BioNTech.Caso clínico: mujer latina de 32 años que desarrolló parálisis facial derecha después de recibir la primera dosis de la vacuna ARNm BNT162b2 el 7 de abril de 2021; con paresia facial derecha, ausencia de arrugas en la frente, surco labio-bucal y pliegue nasolabial, así como espasmos de los músculos faciales y periorbitarios y dolor latero-cervical. Se descartaron posibles etiologías, se le indicó prednisona, gabapentina y topiramato, con TAC de cráneo simple sin alteraciones, logrando mejoría paulatina hasta la recuperación completa funcional a los 15 días, con evolución benigna, congruente con la evolución natural de la enfermedad, clasificándola como parálisis de Bell idiopática.Conclusiones: aunque no se puede establecer una relación causal, el momento y el modo de aparición de la parálisis sugieren fuertemente la relación con la aplicación de la vacuna BNT162b2. Dada la ecomendación de las autoridades sanitarias de vigilar los casos de parálisis de Bell, y la vigilancia de eventos upuestamente atribuibles a la vacunación (ESAVI), se trata del primer caso reportado en la literatura en población mexicana, por lo que consideramos que debe compartirse con la comunidad científica de manera oportuna.

Background: BNT162b2 (Pfizer-BioNTech) is a nucleosidemodified mRNA vaccine formulated with lipid nanoparticles for the prevention of COVID-19 disease caused by SARSCoV-2 infection. In early December 2020, BNT162b2 received an emergency use authorization, initial efficacy and safety data have been released, consumer / patient information sheets for vaccines distributed in North America do not warn of Bell's palsy as a possible adverse effect. We reported the case of a patient who developed Bell's palsy on the right side in less than 3 hours after the application of the first dose of the Pfizer-BioNTech COVID-19 vaccine. Clinical case: 32-year-old latina woman who developed right facial paralysis after receiving the first dose of the BNT162b2 mRNA vaccine on April 7, 2021; with right facial paresis, absence of forehead wrinkles, lip-buccal sulcus and nasolabial fold; spasms of the facial and periorbital muscles, laterocervical pain; possible etiologies were ruled out, prednisone, gabapentin and topiramate. CT without alterations, achieving gradual improvement; until full functional recovery after 15 days. With benign evolution, congruent with the natural history of the disease, classifying it as idiopathic Bell's palsy.Conclusions: Although a causal relationship cannot be established, the time and mode of appearance of the paralysis suggested a relationship with the application of the BNT162b2 vaccine. Given the recommendation of the health authorities to monitor the cases of Bell's palsy, and the surveillance of events upposedly attributable to vaccination (ESAVI) and as it is the first case reported in the literature, in the mexican population, we believe that this case should be shared with the scientific community in a timely manner.

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.

Antecedentes de vacunación en pacientes con COVID-19 / COVID-19 patients and vaccination

Introduction: Vaccines against COVID-19 are effective. However, a percentage of people with a complete vaccination scheme are at risk of contracting and becoming ill from COVID-19. These cases are known as "vaccinated cases of infection". Objective: To identify the clinical characteristics of patients with SARS-CoV-2 infection with a history of vaccination for COVID-19. Methods: Retrospective cohort study in 271 vaccinated and positive patients who attended medical units in Baja California Sur, with or without a complete scheme and registered in SINOLAVE. Clinical characteristics, management, sequelae and mortality were analyzed. Descriptive statistics and association measures were used. Authorized by the ethics and research committees. Results: Age 48.5 ± 12.1 years, 19.5% met the definition of infection in vaccinated, 93% with outpatient management, 3.7% mortality, the most frequent comorbidity: diabetes / hypertension. 92% of the cases vaccinated with Cansino had COVID, followed by Pfizer with 26%. There is a higher risk of hospitalization and mortality in patients with an incomplete scheme. Conclusions: The vaccines are effective, most of the cases were ambulatory. Patients vaccinated with Cansino showed a higher COVID infection, the reinforcement of this vaccine could reduce the disease in patients already vaccinated. Of the patients who died, the majority did not have a complete vaccination schedule.

Introducción: Las vacunas contra la COVID-19 son efectivas. Sin embargo, un porcentaje de personas con esquema completo de vacunación tiene riesgo de contagiarse y enfermar por COVID-19. Estos casos se conocen como "casos de infección en vacunados". Objetivo: Identificar las características clínicas de los pacientes con infección por SARS-COV-2 con antecedente de vacunación para COVID-19.Métodos: Estudio de cohorte retrospectivo con 271 vacunados y positivos que acudieron a las unidades médicas en Baja California Sur, con esquema completo o sin él y registrados en el SINOLAVE. Se analizaron características clínicas, manejo, secuelas y mortalidad. Se utilizó estadística descriptiva y medidas de asociación. El estudio fue autorizado por los comités de ética e investigación. Resultados: Edad: 48.5 ± 12.1 años; 19.5% cumplieron con la definición de infección en vacunados; 93% con manejo ambulatorio; mortalidad del 3.7%; la comorbilidad mas frecuente: diabetes/hipertensión. El 92% de los casos vacunados con Cansino presentaron COVID, seguido por los que recibieron Pfizer, con el 26%. Existe mayor riesgo de hospitalización y mortalidad en pacientes con esquema incompleto. Conclusiones: las vacunas son efectivas, la mayoría de los casos fueron ambulatorios. Los pacientes vacunados con Cansino mostraron mayor infección por SARS-CoV-2; el refuerzo de esta vacuna, podría disminuir la enfermedad en los pacientes ya vacunados. De los pacientes que murieron, la mayoría no tenía esquema completo de vacunación.

Linfadenopatía reactiva por vacuna Pfizer-BioNTech para COVID-19: reporte de un caso / Reactive lymphadenopathy due to Pfizer-BioNTech COVID-19 vaccine: a case report

Uno de los efectos secundarios encontrados en pacientes con antecedente de vacunación por COVID-19, especialmente con la vacuna Pfizer-BioNTech, es la aparición de múltiples adenopatías hiperplásicas, principalmente en los ganglios linfáticos axilares, supraclaviculares e infraclaviculares ipsilaterales al sitio de vacunación. Presentamos el caso de una paciente femenina de 33 años, con aparición de masa dolorosa supraclavicular izquierda, quien una semana antes había sido vacunada con la primera dosis de la vacuna Pfizer-BioNTech en región deltoidea izquierda. Los hallazgos citológicos fueron sugestivos de una enfermedad linfoproliferativa, y el estudio histopatológico reveló linfadenopatía reactiva con proliferación de inmunoblastos B activados, secundaria a la vacunación contra COVID-19. Aportamos a la literatura con la caracterización de los hallazgos histopatológicos de la linfadenopatía posvacunación contra COVID-19. Es importante que los médicos tratantes y radiólogos estén familiarizados con este diagnóstico diferencial, para brindar recomendaciones adecuadas basadas en un seguimiento a corto plazo, en lugar de realizar biopsias, intervenciones y conductas inmediatas innecesarias en el manejo de los pacientes

One of the side effects found in patients with a history of vaccination for COVID-19, especially with the Pfizer-BioNTech vaccine, is the appearance of multiple hyperplastic adenopathies, mainly axillary, supraclavicular and infraclavicular lymph nodes ipsilateral to the vaccination site. We present the case of a 33-year-old female patient, with the appearance of a painful left supraclavicular mass, who was vaccinated a week earlier with the first dose of the Pfizer-BioNTech vaccine in the left deltoid region. The cytological findings were suggestive of a lymphoproliferative disease, and the histopathological study revealed reactive lymphadenopathy with proliferation of activated B immunoblasts, secondary to vaccination against COVID-19. We contribute to the literature with the characterization of the histopathological findings of COVID-19 post-vaccination lymphadenopathy. It is important for treating physicians and radiologists to be familiar with this differential diagnosis, in order to provide appropriate recommendations based on short-term follow-up, instead of performing unnecessary immediate biopsies or interventions in patient management.

Tiroiditis subaguda y tirotoxicosis posterior a vacuna contra SARS-CoV-2: reporte de 2 casos / Subacute thyroiditis and thyrotoxicosis after SARS-CoV-2 vaccine: report of 2 cases

La enfermedad por coronavirus SARS-CoV-2 que surgió en el año 2019 (COVID-19), ha obligado al rápido desarrollo de vacunas para prevenir su propagación e intentar controlar la pandemia. Dentro de las vacunas desarrolladas, las primeras en ser aprobadas con una tecnología nueva en el campo de la vacunación, fueron las vacunas basadas en ARNm (ácido ribonucleico mensajero), que lograron tasas de efectividad cercanas al 95 % para la prevención de la enfermedad COVID-19 grave. Los eventos adversos comunes son reacciones locales leves, pero ha habido varios informes de pacientes que desarrollaron tiroiditis subaguda y disfunción tiroidea después de recibir la vacuna contra SARS-CoV-2. Este artículo presenta dos casos de tiroiditis subaguda poco después de recibir la vacuna contra COVID-19

The SARS-CoV-2 coronavirus disease which emerged in 2019 (COVID-19), has forced the rapid development of vaccines to prevent the spread of infection and attempt to control the pandemic. Among the vaccines developed, one of the first to be approved with a new technology in the field of vaccination, was the mRNA (messenger ribonucleic acid) vaccine, with rates of effectiveness close to 95% for the prevention of severe COVID-19 disease. Common adverse events are mild local reactions, but there have been some reports of patients developing sub-acute thyroiditis and thyroid dysfunction after receiving the SARS-CoV-2 vaccine. This article presents two case reports of subacute thyroiditis shortly after receiving the COVID-19 vaccine

Vacinas COVID-19 e suas implicações imunológicas: uma revisão de literatura / COVID-19 vaccines and immunological implications: A literature review

A COVID-19 e seus mecanismos imunológicos são, atualmente, temas de grande relevância mundial. Suas manifestações clínicas e as perigosas complicações decorrentes da tempestade de citocinas motivaram a criação de vacinas contra o SARS-CoV-2 em um ritmo acelerado, gerando desconfianças e diferentes níveis de eficácia e segurança. Este estudo trata-se de um artigo de revisão que abordou pesquisas publicadas no período de 2020 e 2021, utilizando as bibliotecas eletrônicas SciELO (Scientific Electronic Library Online), PubMed, LILACS (Literatura Latino-Americana e do Caribe em Ciências da Saúde) e MEDLINE com o rastreamento específico por meio dos seguintes descritores: vacinas COVID-19, SARS-CoV-2, imunologia do COVID-19. Questões como o mecanismo imunológico, eficácia e efeitos adversos das vacinas disponíveis no mercado mundial atual foram amplamente discutidas.

COVID-19 and immunological mechanisms currently are topics of great worldwide relevance. Clinical manifestations and the dangerous complications resulting from a cytokine storm motivated the creation of vaccines against SARS-CoV-2 at an accelerated pace, generating suspicions and different levels of efficacy and safety. This is a review article addressing research published in 2020 and 2021. The electronic libraries SciELO (Scientific Electronic Library Online), PubMed, LILACS (Latin American and Caribbean Literature in Health Sciences), and MEDLINE were used for specific screening with the following descriptors: COVID- 19 vaccines, SARS-CoV-2, immunology of COVID-19. Issues such as the immunological mechanism, efficacy, and adverse effects of vaccines currently available on the world market are widely discussed.

Vacina COVID-19 em pacientes com urticária ­ Posicionamento do Departamento Científico de Urticária da Associação Brasileira de Alergia e Imunologia (ASBAI) / COVID-19 vaccine in patients with urticaria ­ Position statement of the Scientific Department of Urticaria of the Brazilian Association of Allergy and Immunology (ASBAI)

Com o início do programa de vacinação contra a COVID-19 no Brasil, surgiu uma série de questionamentos relacionados ao uso dos imunizantes em pacientes com doenças imunoalérgicas. Neste documento, o Departamento Científico de Urticária da Associação Brasileira de Alergia e Imunologia (ASBAI) se posiciona revisando as principais dúvidas relacionadas à imunização para COVID-19 em pacientes com urticária.

As the COVID-19 vaccination program started in Brazil, many questions have arisen regarding the use of vaccines in patients with immune-allergic diseases. In this document, the Scientific Department of Urticaria of the Brazilian Association of Allergy and Immunology takes a stand by reviewing the main queries regarding COVID-19 immunization in patients with urticaria.

Vacinas COVID-19 e imunobiológicos / COVID-19 vaccines and immunobiological drugs

Os medicamentos imunobiológicos têm sido frequentemente utilizados no tratamento das doenças alérgicas e de natureza imunológica. Esses agentes regulam a resposta imunológica do tipo 2 nas doenças alérgicas ou atuam em diversas vias de ativação alteradas nos erros inatos da imunidade. Com o surgimento da pandemia COVID-19 um crescente número de pacientes em uso de imunobiológicos para essas condições deverão ser vacinados contra o vírus SARS-CoV-2. Dessa forma, existe a necessidade de avaliar a segurança e eficácia destas vacinas nos pacientes em uso de imunobiológicos para asma, dermatite atópica, rinossinusite crônica com pólipos nasais, urticária crônica e erros inatos da imunidade. Foi realizada uma busca de literatura recente relevante sobre imunobiológicos e vacinas COVID-19 no PubMed. Existe um consenso de manutenção desses agentes durante a pandemia COVID-19, embora nas doenças alérgicas os mesmos devam ser suspensos durante a infecção ativa. Por outro lado, dados disponíveis em relação à segurança e eficácia das vacinas contra a COVID-19 nesse grupo de pacientes são escassos. Existem relatos do uso de outras vacinas inativadas em associação com alguns imunobiológicos demonstrando serem eficazes e seguras. Portanto, considerando o risco potencial da infecção COVID-19, especialmente nos pacientes portadores de erros inatos da imunidade, recomendamos que as vacinas contra a COVID-19 sejam utilizadas nos pacientes em uso de imunobiológicos. Desta forma, existe uma necessidade de estudos que avaliem estas questões haja vista que a terapia com diversos imunobiológicos tem sido amplamente utilizada nos pacientes com doenças alérgicas e de natureza imunológica.

Immunobiological drugs have often been used to treat allergic and immunological diseases. These agents regulate the type 2 immune response in allergic diseases or act on different activation pathways altered in inborn errors of immunity. With the emergence of the COVID-19 pandemic, an increasing number of patients with these conditions using these agents should be vaccinated against the SARS-CoV-2 virus. Thus, there is a need to evaluate the safety and efficacy of these vaccines in patients using biologics for asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, chronic urticaria, and inborn errors of immunity. A search for relevant recent literature on biologics and COVID-19 vaccines was conducted on PubMed. There is a consensus on maintaining the use of these agents during the COVID-19 pandemic, although in allergic diseases they must be suspended during active infection. Conversely, the available data regarding the safety and efficacy of the COVID-19 vaccines are scarce. There are reports of the use of other inactivated vaccines with some biologics proving to be effective and safe. Therefore, considering the potential risk of COVID-19 infection, especially in patients with inborn errors of immunity, we recommend that COVID-19 vaccines should be used in patients using biologics. Thus, there is a need for studies to assess these issues, given that therapy with several biologics has been widely used in patients with allergic and immunological diseases.

Should a patient with systemic mastocytosis be vaccinated against COVID-19? / Deve um doente com mastocitose sistêmica ser vacinado contra a COVID-19?

A 26-year-old woman was referred to the allergy department for two episodes of anaphylaxis after intake of non-steroidal antiinflammatory drugs. In both episodes she was evaluated at the emergency department, and her levels of tryptase were 141 ug/L and 117 ug/L, respectively. Baseline tryptase was 92 ug/L. Bone marrow biopsy, myelogram, and immunophenotypic study were performed, confirming systemic mastocytosis. In patients with mast cell disorders, the risk of anaphylaxis after mRNA vaccine against COVID-19 has been under debate. Considering the occupational risk of COVID-19, the risk of anaphylaxis upon exposure to the vaccine was discussed with the patient and, after consent, Pfizer/BioNTech® BNT162B2 was administered under allergist supervision. No premedication was administered and both vaccine inoculations occurred without eliciting mast cell symptoms.

Mulher de 26 anos enviada à consulta de imunoalergologia após dois episódios de anafilaxia no contexto de ingestão de antiinflamatórios. Em ambos os episódios foi observada no Serviço de Urgência. Os valores de triptase nos episódios foram 141 ug/L e 117 ug/L, respetivamente. A triptase basal 92 ug/L. Realizou biópsia de medula óssea, mielograma e estudo imunofenotípico que confirmaram mastocitose sistêmica. Nos doentes com doença mastocitária, o risco de anafilaxia após administração de vacinas mRNA contra a COVID-19 tem sido debatido. Considerando o risco de exposição à COVID-19, o risco de anafilaxia após administração da vacina foi discutido com a doente e, após consentimento, a vacina Pfizer/BioNTech® BNT162B2 foi administrada sob vigilância de um alergologista. Não foi administrada pré-medicação, e a doente recebeu as duas doses da vacina sem evidenciar sintomatologia relacionada com ativação mastocitária.

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.

Vacinação contra COVID-19 em pacientes portadores de angioedema hereditário: recomendações do Grupo de Estudos Brasileiro em Angioedema Hereditário (GEBRAEH) / COVID-19 vaccination in patients with hereditary angioedema: recommendations from the Brazilian Group for the Study on Hereditary Angioedema (GEBRAEH)

No curso da pandemia da COVID-19, o desenvolvimento rápido de vacinas seguras e eficazes é a principal estratégia de saúde pública para conter a propagação da doença. Nesse contexto, esclarecimentos em relação à prioridade e segurança da vacinação contra COVID-19 em pacientes portadores de angioedema hereditário (AEH), assim como de outras doenças, são necessários. Todos os pacientes devem receber a vacina seguindo a estratégia do Ministério da Saúde e manter as medidas de higiene, uso de máscaras e distanciamento social até o controle da pandemia.

During the COVID-19 pandemic, the rapid development of safe and effective vaccines is the main public health strategy to avoid the spread of the disease. In this context, clarifications regarding the priority and safety of vaccination against COVID-19 in patients with hereditary angioedema (HAE), as well as other diseases, are needed. All patients should receive the vaccine according to the Brazilian Ministry of Health strategy and adhere to measures such as maintaining general hygienic measures, wearing masks, and keeping social distance until the pandemic is controlled.