RESUMO
OBJECTIVES: To describe the trend in the frequency of adverse events (AE) records associated to pertussis component vaccines between January 1st, 2015 and June 30th, 2020 in infants younger than 2-years-old in Chile, by reviewing the records submitted to the AEFI NIP, stratified by DTP-vaccine type, wP or aP. MATERIALS AND METHODS: This was a retrospective observational study including all AEFI records of DTP (either aP or wP)-containing vaccines in the described sample. A descriptive analysis was performed according to vaccine type and AEFI, using MedDRA terminology. RESULTS: The total number of AEFI reports was 1,697: 815 corresponding to wP vaccines, 417 to aP vaccines, and 465 with unknown type. The reporting rates for the years 2015 to 2020 were 40.1, 56.2, 37.1, 24.7, 19.1, and 12.2 per 100,000 doses administered, respectively. The most reported AEFI were injection site erythema (42.9%), pyrexia (35.7%), and pain at the injection site (29.2%). Among all cases, 5.8% were SAEs (n = 98), 5.9% were SAEs for wP vaccines (n = 48) and 5.3% were for aP vaccines (n = 22). DISCUSSION: A significant decrease in AEFI reports was observed as of 2018, the year that the DTaP-IPV-HepB-Hib was introduced in the NIP.
Assuntos
Vacina contra Difteria, Tétano e Coqueluche , Vacinas contra Difteria, Tétano e Coqueluche Acelular , Pré-Escolar , Chile/epidemiologia , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacinas contra Difteria, Tétano e Coqueluche Acelular/efeitos adversos , Humanos , Lactente , Vacina contra Coqueluche/efeitos adversos , Estudos Retrospectivos , Vacinas CombinadasRESUMO
INTRODUCCIÓN: La hipotonía-hiporrespuesta (HHR) es uno de los efectos adversos supuestamente atribuibles a la vacunación e inmunización de tipo neurológico más notificados. El impacto a largo plazo a nivel del neurodesarrollo no es completamente conocida. OBJETIVO: Caracterizar los eventos de HHR post vacuna pentavalente notificados entre 2014 y 2018 al Ministerio de Salud Pública (MSP) de Uruguay. Realizar el tamizaje del neurodesarrollo de los que al momento de la evaluación tenían menos de 6 años de edad. METODOLOGÍA: Estudio descriptivo de las notificaciones al Sistema Nacional de Farmacovigilancia del MSP. Se realizó el tamizaje del neurodesarrollo con la Guía Nacional para la Vigilancia del Desarrollo. RESULTADOS: 30 casos, la mayoría de breve duración, en las primeras horas post primera dosis y con recuperación espontánea. Requirieron hospitalización 29. Se realizó el tamizaje del neurodesarrollo en 16. La media de tiempo entre el evento y esta evaluación fue 2 años y 2 meses. Fue normal la prueba de tamizaje en 15. En uno se detectó un retraso del lenguaje. CONCLUSIONES: Los episodios de HHR se presentaron con características similares a las descritas en la bibliografía. A pesar de las limitaciones del estudio, no se encontraron retrasos ni desvíos del desarrollo en los niños evaluados.
BACKGROUND: Hypotonic-hyporesponsive episodes (HHE) is one frequently reported neurologic adverse effect supposedly attributable to vaccination and immunization. Its long-term impact on neurodevelopment is not completely known. AIM: To characterize the post-pentavalent vaccine HHE events reported to the Uruguayan Ministry of Health (M of H) between 2014 and 2018. To perform neurodevelopment screening of those who were under 6 years of age at the time of evaluation. METHODS: Descriptive study of the reports made to the National Farmacosurveillance System of the M of H. Neurodevelopment screening was performed using the National Guidelines for Developmental Surveillance. RESULTS: 30 cases were studied. Most cases occurred after the first doses, were of short duration and during the first hours after vaccination, with spontaneous recovery. Median time between the event and this evaluation was 2 years and 2 months. Screening tests were normal in 15. Delay in the language area was detected in one case. CONCLUSIONS: HHE events had similar characteristics to those described in the literature, with no severe short-term complications. Despite the limitations of the present study, no delays nor deviations were found in the development of the children who were evaluated.
Assuntos
Humanos , Masculino , Feminino , Lactente , Pré-Escolar , Criança , Vacinas Combinadas/efeitos adversos , Hipotonia Muscular/etiologia , Hipotonia Muscular/epidemiologia , Uruguai/epidemiologia , Vacina contra Coqueluche/efeitos adversos , Imunização , Vacinação , FarmacovigilânciaRESUMO
Beginning in 1974, the date on which the Expanded Program on Immunization was established in the Americas, the number of deaths and disabilities due to certain infectious diseases decreased considerably thanks to universally applied vaccines. A program that initially included four vaccines that protected against six diseases (tuberculosis, diphtheria, pertussis, tetanus, polio and measles) was consolidated, over the years, by incorporating new vaccines and significantly raising coverage rates. The Sociedad Argentina de Pediatría (Argentine Society of Pediatrics), as a leader of opinion, played a leading role in the incorporation of new vaccines, currently reaching one of the most complete vaccination calendars in the world, which improves the levels of inequality and inequity in public health. Taking into account the significant role of the pediatrician in decision-making, the National Committee of Infectious Diseases, together with the Subsidiary Committees, prepared a document on updates and recommendations for 2018 on Polio, Rotavirus, Pneumococcus, Meningococcus, Human Papillomavirus, Chickenpox, Flu, Dengue vaccines and Whooping Cough.
A partir del año 1974, cuando se estableció el Programa Ampliado de Inmunizaciones en las Américas, la cantidad de muertes y discapacidades por enfermedades infecciosas disminuyó de manera considerable gracias a las vacunas aplicadas. Inicialmente, se incluyeron cuatro vacunas que protegían contra seis enfermedades (tuberculosis, difteria, coqueluche, tétanos, polio y sarampión), y, a través de los años, al incorporar nuevas vacunas, aumentaron considerablemente las tasas de cobertura. La Sociedad Argentina de Pediatría tuvo un rol destacado en la incorporación de nuevas vacunas y, en la actualidad, hay uno de los calendarios de vacunación más completos del mundo, lo que permite mejorar los niveles de desigualdad e inequidad en salud pública. Teniendo en cuenta el rol que tiene el pediatra en la toma de decisiones, el Comité Nacional de Infectología, junto con comités de filiales, elaboró un documento sobre actualizaciones y recomendaciones de 2018 acerca de polio, rotavirus, neumococo, meningococo, virus del papiloma humano, varicela, gripe, dengue y coqueluche.
Assuntos
Programas de Imunização/normas , Esquemas de Imunização , Vacina contra Coqueluche/administração & dosagem , Vacinas Estreptocócicas/administração & dosagem , Vacinas Virais/administração & dosagem , Adolescente , Argentina/epidemiologia , Varicela/epidemiologia , Varicela/prevenção & controle , Criança , Pré-Escolar , Tomada de Decisão Clínica , Contraindicações , Dengue/epidemiologia , Dengue/prevenção & controle , Diagnóstico Diferencial , Armazenamento de Medicamentos/métodos , Feminino , Saúde Global , Humanos , Lactente , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , América Latina/epidemiologia , Masculino , Infecções Meningocócicas/epidemiologia , Infecções Meningocócicas/prevenção & controle , Infecções Meningocócicas/transmissão , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Pediatria , Vacina contra Coqueluche/efeitos adversos , Vacina contra Coqueluche/imunologia , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Poliomielite/diagnóstico , Poliomielite/epidemiologia , Poliomielite/prevenção & controle , Poliomielite/transmissão , Vacinas contra Poliovirus/administração & dosagem , Vacinas contra Poliovirus/efeitos adversos , Vacinas contra Poliovirus/imunologia , Infecções por Rotavirus/epidemiologia , Infecções por Rotavirus/prevenção & controle , Sociedades Médicas , Vacinas Estreptocócicas/efeitos adversos , Vacinas Estreptocócicas/imunologia , Vacinas Conjugadas/administração & dosagem , Vacinas Conjugadas/efeitos adversos , Vacinas Conjugadas/imunologia , Vacinas Virais/efeitos adversos , Vacinas Virais/imunologia , Coqueluche/epidemiologia , Coqueluche/prevenção & controleRESUMO
BACKGROUND: Adverse events following immunization (AEFI) requires special consideration in patients with primary immunodeficiency diseases (PID) because they may represent a "red flag" for the initial diagnosis and may cause disease complications. Therefore, the definition of appropriate vaccination schemes is a major issue in PID. The aim of this study is to describe the AEFI in a cohort of PID patients. METHODS: Medical records from 379 PID patients were included. AEFI severity was classified according to the WHO 1999 guidelines. Causality was assessed using the Clinical Immunization Safety Assessment (CISA) 2009 criteria. RESULTS: Evidence of AEFI was found in 26 medical records and represented a total of 29 reactions. Most of the AEFI were observed in patients with idiopathic hypogammaglobulinemia (IHG), chronic granulomatous disease (CGD) and severe combined immunodeficiency (SCID), representing 10, 4 and 4 cases, respectively. A total of 21 reactions were associated with replicative vaccines, 7 of which were serious cases related to Bacille Calmette-Guérin (BCG). BCG was also the vaccine more often associated with definitive AEFI in PID. In addition to BCG-related complications, seizures were the most serious AEFI among PID patients. CONCLUSIONS: Our study included a large cohort of PID patients and confirmed an increased risk of serious AEFI in these populations. The design and implementation of neonatal screening strategies for the early detection of congenital lymphopenias and other PID are urgently needed to avoid serious complications of the BCG vaccine usually applied immediately after birth. Our findings also support the use of the acellular pertussis vaccine to minimize the appearance of seizures in PID patients vaccinated with diphtheria, pertussis and tetanus (DPT).
Assuntos
Síndromes de Imunodeficiência/fisiopatologia , Vacinação/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Idoso de 80 Anos ou mais , Vacina BCG/efeitos adversos , Criança , Pré-Escolar , Estudos de Coortes , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Feminino , Humanos , Síndromes de Imunodeficiência/imunologia , Masculino , Pessoa de Meia-Idade , Vacina contra Coqueluche/efeitos adversos , Convulsões/induzido quimicamente , Adulto JovemRESUMO
The resurgence of pertussis in the world and in our country has questioned the effectiveness of cellular and acellular vaccines. The reason why pertussis has not been controlled or eliminated after 70 years of implementation of the vaccination is probably multifactorial. This article, on the basis of questions and answers, describes the benefits and limitations of both cellular and acellular vaccines and suggests new strategies of vaccination in childhood. It is a fact that the currently applied vaccination does not eliminate the circulation of Bordetella pertussis in the community. Perhaps the introduction of vaccines with live B. pertussis, inhalation, will be able to eliminate the disease around the world.
Assuntos
Bordetella pertussis/imunologia , Vacina contra Coqueluche/administração & dosagem , Coqueluche/prevenção & controle , Chile , Humanos , Vacina contra Coqueluche/efeitos adversos , Vacinação , Vacinas Acelulares/administração & dosagem , Vacinas Acelulares/efeitos adversosRESUMO
The resurgence of pertussis in the world and in our country has questioned the effectiveness of cellular and acellular vaccines. The reason why pertussis has not been controlled or eliminated after 70 years of implementation of the vaccination is probably multifactorial. This article, on the basis of questions and answers, describes the benefits and limitations of both cellular and acellular vaccines and suggests new strategies of vaccination in childhood. It is a fact that the currently applied vaccination does not eliminate the circulation of Bordetella pertussis in the community. Perhaps the introduction of vaccines with live B. pertussis, inhalation, will be able to eliminate the disease around the world.
El resurgimiento de la coqueluche en el mundo y en nuestro país ha puesto en tela de juicio la eficacia de las vacunas celulares y acelulares. Las razones de por qué la coqueluche no es controlada ni eliminada después de 70 años de implementación de la vacunación son diversas y probablemente multifactoriales. En este artículo, en base a preguntas y respuestas, se describen las bondades y limitaciones de tanto vacunas celulares como acelulares y queda sugerida una mejor forma de administrar ambas en la infancia. Es un hecho que la vacunación actualmente aplicada no elimina la circulación de Bordetella pertussis en la comunidad. Tal vez la introducción de vacunas con B. pertussis viva, inhalatoria, sea capaz de eliminar la enfermedad de la humanidad.
Assuntos
Humanos , Bordetella pertussis/imunologia , Vacina contra Coqueluche/administração & dosagem , Coqueluche/prevenção & controle , Chile , Vacina contra Coqueluche/efeitos adversos , Vacinação , Vacinas Acelulares/administração & dosagem , Vacinas Acelulares/efeitos adversosRESUMO
The introduction of routine vaccination against whooping cough caused a drastic decline in the incidence of this disease, but remains today a public health problem even in countries with high vaccination coverage. However, with this decrease in cases, there were an emergence of neurological severe adverse events such as the "hypotonic-hyporesponsive episodes" (HHE), characterized by sudden loss of muscle tone associated with poor response to stimuli and skin pallor or cyanosis. The HHE is a rare phenomenon after administration of pertussis vaccine, but it is essential for health workers recognition of such reactions, especially in the 48 hours following vaccination. Although sometimes can become difficult to attribute a causal relationship between vaccine administration and an adverse effect, any suspicious events should be reported.
Assuntos
Hipotonia Muscular/induzido quimicamente , Vacina contra Coqueluche/efeitos adversos , Humanos , Lactente , MasculinoRESUMO
La introducción de la vacunación sistemática contra la tos ferina determinó un descenso drástico en la incidencia de esta patología, aunque todavía representa un problema de salud pública, incluso en los países con alta cobertura de vacunación. Sin embargo, además de la disminución de los casos por la proflaxis activa, se ha observado la emergencia de efectos adversos neurológicos graves, como los denominados "episodios de hipotonía-hiporreactividad" (HHE), caracterizados por una pérdida súbita del tono muscular asociada a escasa respuesta a los estímulos y palidez cutánea o cianosis. Los HHE son un fenómeno infrecuente después de la administración de la vacuna con un componente antitosferínico, pero es fundamental que el personal sanitario sepa reconocerlos, sobre todo en las siguientes 48 horas de la vacunación. Aunque en ocasiones es difícil establecer una relación causal entre la administración de la vacuna y un efecto adverso, debe comunicarse cualquier evento sospechoso.(AU)
The introduction of routine vaccination against whooping cough caused a drastic decline in the incidence of this disease, but remains today a public health problem even in countries with high vaccination coverage. However, with this decrease in cases, there were an emergence of neurological severe adverse events such as the "hypotonic-hyporesponsive episodes" (HHE), characterized by sudden loss of muscle tone associated with poor response to stimuli and skin pallor or cyanosis. The HHE is a rare phenomenon after administration of pertussis vaccine, but it is essential for health workers recognition of such reactions, especially in the 48 hours following vaccination. Although sometimes can become diffcult to attribute a causal relationship between vaccine administration and an adverse effect, any suspicious events should be reported.(AU)
Assuntos
Humanos , Lactente , Masculino , Hipotonia Muscular/induzido quimicamente , Vacina contra Coqueluche/efeitos adversosRESUMO
La introducción de la vacunación sistemática contra la tos ferina determinó un descenso drástico en la incidencia de esta patología, aunque todavía representa un problema de salud pública, incluso en los países con alta cobertura de vacunación. Sin embargo, además de la disminución de los casos por la proflaxis activa, se ha observado la emergencia de efectos adversos neurológicos graves, como los denominados "episodios de hipotonía-hiporreactividad" (HHE), caracterizados por una pérdida súbita del tono muscular asociada a escasa respuesta a los estímulos y palidez cutánea o cianosis. Los HHE son un fenómeno infrecuente después de la administración de la vacuna con un componente antitosferínico, pero es fundamental que el personal sanitario sepa reconocerlos, sobre todo en las siguientes 48 horas de la vacunación. Aunque en ocasiones es difícil establecer una relación causal entre la administración de la vacuna y un efecto adverso, debe comunicarse cualquier evento sospechoso.
The introduction of routine vaccination against whooping cough caused a drastic decline in the incidence of this disease, but remains today a public health problem even in countries with high vaccination coverage. However, with this decrease in cases, there were an emergence of neurological severe adverse events such as the "hypotonic-hyporesponsive episodes" (HHE), characterized by sudden loss of muscle tone associated with poor response to stimuli and skin pallor or cyanosis. The HHE is a rare phenomenon after administration of pertussis vaccine, but it is essential for health workers recognition of such reactions, especially in the 48 hours following vaccination. Although sometimes can become diffcult to attribute a causal relationship between vaccine administration and an adverse effect, any suspicious events should be reported.
Assuntos
Humanos , Lactente , Masculino , Hipotonia Muscular/induzido quimicamente , Vacina contra Coqueluche/efeitos adversosRESUMO
An improved whole cell pertussis vaccine, designated as Plow, which is low in endotoxicity due to a chemical extraction of lipo-oligosaccharide (LOS) from the outer membrane, was evaluated for safety, immunogenicity and potency, comparatively to a traditional whole cell pertussis vaccine. Current whole cell pertussis vaccines are effective but contain large quantities of endotoxin and consequently display local and systemic adverse reactions after administration. Endotoxin is highly inflammatory and contributes considerably to the reactogenicity as well as the potency of these vaccines. In contrast, acellular pertussis vaccines hardly contain endotoxin and are significantly less reactogenic, but their elevated costs limit their global use, especially in developing countries. In this paper, bulk products of Plow and a traditional whole cell vaccine, formulated as plain monocomponents or combined with diphtheria and tetanus toxoids (DTPlow or DTP, respectively) were compared by in vitro and in vivo assays. Chemical extraction of LOS resulted in a significant decrease in endotoxin content (20%) and a striking decline in endotoxin related toxicity (up to 97%), depending on the used in vitro or in vivo test. The LOS extraction did not affect the integrity of the product and, more importantly, did not affect the potency and/or stability of DTPlow. Moreover, hardly any differences in antibody and T-cell responses were observed. The development of Plow is a significant improvement regarding the endotoxicity of whole cell pertussis vaccines and therefore a promising and affordable alternative to currently available whole cell or acellular pertussis vaccines for developing countries.