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2.
Vaccine ; 41(39): 5715-5721, 2023 09 07.
Artículo en Inglés | MEDLINE | ID: mdl-37550146

RESUMEN

Despite Brazil's tradition of successful mass immunization programs, the country has been experiencing alarming declines in vaccination coverage, especially among children. That is aggravated by the growth of anti-vaccine movements and the spread of health misinformation in social media in the last decade, which have worsened during the COVID-19 outbreak. Several reports link populism and far-right politicians to anti-vaccination support worldwide, which was also the case in Brazil during president Jair Bolsonaro's administration. This project aimed to identify the circulating pro and anti-vaccine narratives in Portuguese on Twitter, during a crucial decision-making period regarding childhood vaccination in Brazil, from December 9, 2021, until February 9, 2022. From the over one million tweets and four million retweets collected, we identified two well-defined groups, one in favor and another against vaccination. Within the sample, we selected 1500 influencer tweets with the highest impact (>500 retweets) and conducted content analysis. Although the pro-vaccine influencers were more retweeted than anti-vaxxer ones, we observed that anti-vaccine movements were more succesful in framing discussions on Twitter. The subject of COVID-19 was the target of political polarization embedded in populist, anti-science and anti-traditional media discourses promoted by anti-vaxxers. As a counterpart, the pro-vaccine influencers reacted inarticulately, focusing on criticizing the anti-vaccination actors, attitudes, and policies instead of promoting vaccines. Based on reults, we claim that a well-coordinated network of health communicators from science centers and health institutions, in partnership with properly briefed social media influencers and fact-checking sources, would more efectively pre-tempt the public about vaccine misinformation.


Asunto(s)
COVID-19 , Medios de Comunicación Sociales , Vacunas , Niño , Humanos , Brasil/epidemiología , COVID-19/prevención & control , Vacunas/efectos adversos , Vacunación
3.
Stat Med ; 42(18): 3283-3301, 2023 08 15.
Artículo en Inglés | MEDLINE | ID: mdl-37221996

RESUMEN

In the postmarket drug and vaccine safety surveillance, when the number of adverse events follows a Poisson distribution, the ratio between the exposed and the unexposed person-time information is the random variable that governs the decision rule about the safety of the drug or vaccine. The probability distribution function of such a ratio is derived in this paper. Exact point and interval estimators for the relative risk are discussed as well as statistical hypothesis testing. To the best of our knowledge, this is the first paper that provides an unbiased estimator for the relative risk based on the person-time ratio. The applicability of this new distribution is illustrated through a real data analysis aimed to detect increased risk of occurrence of Myocarditis/Pericarditis following mRNA COVID-19 vaccination in Manitoba, Canada.


Asunto(s)
COVID-19 , Vacunas , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos , Vacunas contra la COVID-19 , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas/efectos adversos , Funciones de Verosimilitud , Vacunación , Distribución de Poisson
4.
Mult Scler Relat Disord ; 75: 104741, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37182477

RESUMEN

BACKGROUND: Vaccination in patients with neuromyelitis optica spectrum disorders (NMOSD) is challenging because there is a concern that vaccines can lead to clinical attacks. However, little is known about the risk and the characteristics of attacks occurring after vaccination. METHODS: We performed a systematic review and meta-analysis using PubMed and Embase databases to estimate a summary frequency of attacks occurring after vaccination and describe the clinical features of theses attacks. We defined attacks occurring after vaccination as typical NMOSD attacks that occurred up to 30 days after vaccine administration.  For the frequency of attacks occurring after vaccination, we selected observational studies that reported the number of attacks and total number of patients that received vaccines; for the clinical description of the attacks, case reports and case series were also included. RESULTS: We included 377 participants from 5 studies to estimate the frequency of NMOSD attacks occurring after vaccination. We found a summary frequency of of 2% (95% CI 1-4%, I2 = 0%). We evaluated 17 studies to identify that 13 different vaccines were associated with NMOSD attacks. A higher-than-expected proportion of males, simultaneous optic neuritis and transverse myelitis attacks, and anti-aquaporin 4 antibody negative cases were identified in vaccine-associated attacks from 24 participants from 17 studies. Nearly two-thirds of attacks occurring after vaccination were an initial event of NMOSD. CONCLUSION: The frequency of NMOSD attacks occurring after vaccination is low and non-specific to different vaccine technologies. Our work reinforces the safety of vaccine recommendations in patients with NMOSD.


Asunto(s)
Mielitis Transversa , Neuromielitis Óptica , Neuritis Óptica , Vacunas , Masculino , Humanos , Neuromielitis Óptica/complicaciones , Mielitis Transversa/complicaciones , Neuritis Óptica/complicaciones , Vacunación/efectos adversos , Vacunas/efectos adversos , Autoanticuerpos
5.
BMC Pregnancy Childbirth ; 23(1): 172, 2023 Mar 13.
Artículo en Inglés | MEDLINE | ID: mdl-36915061

RESUMEN

BACKGROUND: There is an urgent need for active safety surveillance to monitor vaccine exposure during pregnancy in low- and middle-income countries (LMICs). Existing maternal, newborn, and child health (MNCH) data collection systems could serve as platforms for post-marketing active surveillance of maternal immunization safety. To identify sites using existing systems, a thorough assessment should be conducted. Therefore, this study had the objectives to first develop an assessment tool and then to pilot this tool in sites using MNCH data collection systems through virtual informant interviews. METHODS: We conducted a rapid review of the literature to identify frameworks on population health or post-marketing drug surveillance. Four frameworks that met the eligibility criteria were identified and served to develop an assessment tool capable of evaluating sites that could support active monitoring of vaccine safety during pregnancy. We conducted semi-structured interviews in six geographical sites using MNCH data collection systems (DHIS2, INDEPTH, and GNMNHR) to pilot domains included in the assessment tool. RESULTS: We developed and piloted the "VPASS (Vaccines during Pregnancy - sites supporting Active Safety Surveillance) assessment tool" through interviews with nine stakeholders, including central-level systems key informants and site-level managers from DHIS2 and GNMNHR; DHIS2 in Kampala (Uganda) and Kigali (Rwanda); GNMNHR from Belagavi (India) and Lusaka (Zambia); and INDEPTH from Nanoro (Burkina Faso) and Manhica (Mozambique). The tool includes different domains such as the system's purpose, the scale of implementation, data capture and confidentiality, type of data collected, the capability of integration with other platforms, data management policies and data quality monitoring. Similarities among sites were found regarding some domains, such as data confidentiality, data management policies, and data quality monitoring. Four of the six sites met some domains to be eligible as potential sites for active surveillance of vaccinations during pregnancy, such as a routine collection of MNCH individual data and the capability of electronically integrating individual MNCH outcomes with information related to vaccine exposure during pregnancy. Those sites were: Rwanda (DHIS2), Manhica (IN-DEPTH), Lusaka (GNMNHR), and Belagavi (GNMNHR). CONCLUSION: This study's findings should inform the successful implementation of active safety surveillance of vaccines during pregnancy by identifying and using active individual MNCH data collection systems in LMICs.


Asunto(s)
Países en Desarrollo , Vacunas , Embarazo , Recién Nacido , Niño , Femenino , Humanos , Zambia , Rwanda , Uganda , Vacunas/efectos adversos , Exactitud de los Datos
6.
Vaccine ; 41(2): 540-546, 2023 01 09.
Artículo en Inglés | MEDLINE | ID: mdl-36496281

RESUMEN

This study examines the personal beliefs held by parents of autistic children in Puerto Rico regarding the cause of their child's autism and how these beliefs may influence parental vaccination decision-making. This study seeks to contribute towards diversifying the autism literature by focusing on an autism community living in a relatively lower income, resource-deficit context. These findings expand our understandings of how parents of autistic children may perceive vaccines and how these perceptions are informed by various sources of knowledge. This ethnographic research study was conducted between May 2017 and August 2019. Methods included 350+ hours of participant-observation and semi-structured interviewing of 35 Puerto Rican parents of autistic children. 32 of these 35 parents interviewed believed autism to be the result of genetic risks that are 'triggered' by an unknown environmental factor. Suggested 'triggers' included various environmental contaminants and vaccinations. The subject of vaccination came up in every interview; 18 interviewed parents did not believe vaccines 'triggered' autism, 3 parents attributed their child's autism entirely to vaccines, while 14 considered vaccines to be one of several possible 'triggers'. It is important to note that no parents interviewed perceived vaccinations to be inherently or universally harmful. Rather, they perceived vaccinations to be one of many possible 'triggers' for a child predisposed to develop autism. In some cases, this perception prompted parents to oppose mandatory vaccination policies on the island. Parents shared nuanced, complex understandings of autism causation that may carry implications for COVID-19 vaccine uptake within the Puerto Rican autistic community.


Asunto(s)
Trastorno Autístico , Padres , Vacilación a la Vacunación , Vacunas , Niño , Humanos , Trastorno Autístico/etiología , COVID-19 , Vacunas contra la COVID-19 , Conocimientos, Actitudes y Práctica en Salud , Puerto Rico , Vacunación/psicología , Vacunas/efectos adversos , Vacilación a la Vacunación/etnología , Vacilación a la Vacunación/psicología , Antropología Cultural , Antropología Médica
7.
Rev Bras Ginecol Obstet ; 44(9): 821-829, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36067796

RESUMEN

Regulations for the vaccination of pregnant women in Brazil occurred in March 2021. Despite the absence of robust data in the literature on the coronavirus disease 2019 (COVID-19) vaccinations in pregnant women, it is understood that the benefit-risk ratio tends to be favorable when considering the pandemic and the high burden of the disease. However, it is still important to monitor for Events Supposedly Attributable to Vaccination or Immunization (ESAVI) and to draw safety profiles of the different platforms used in pregnant and postpartum women. The present study aims to describe the main characteristics of ESAVIs related to COVID-19 vaccines occurring in pregnant women in the first months of the vaccination campaign in Brazil. During the evaluation period, 1,674 notifications of ESAVIs in pregnant women were recorded, and 582 notifications were included for the analysis. Of the 582 ESAVIs identified, 481 (82%) were classified as non-serious adverse events and 101 (17%) as serious adverse events. Ten deaths were identified, including one death which was considered to be causally related to the vaccine. The other nine maternal deaths had causality C, that is, without causal relationship with the vaccine, and most were due to complications inherent to pregnancy, such as pregnancy-specific hypertensive disorder (PSHD) in 4 cases and 3 due to COVID-19. Despite some limitations in our study, we believe it brings new insights into COVID-19 vaccines in this group and will add to the available evidence.


As determinações vacinação nas gestantes foram estabelecidas em março de 2021, no Brasil. Apesar da ausência de dados robustos na literatura da vacinação contra coronavirus disease 2019 (COVID-19) nesse grupo, entende-se que a relação de benefício versus risco tende a ser favorável considerando a situação pandêmica e a elevada carga de doença, tendo justificado o uso dessas vacinas em ampla escala nas gestantes de todo o mundo. Entretanto, o monitoramento dos eventos adversos pós vacinação (EAPVs) torna-se ainda mais importante para traçar um perfil de segurança das diferentes plataformas nas gestantes e puérperas. O presente estudo tem como objetivo descrever as principais características dos EAPVs contra COVID-19 ocorridos nas gestantes nos primeiros meses de campanha da vacinação no Brasil. Foram identificadas 1.674 notificações em gestantes, com a inclusão de 582 EAPVs analisados. Dos 582 EAPVs identificados, 481 (82%) foram classificados como eventos adversos não-graves e 101 (17%) como eventos adversos graves, sendo 10 (9,9%) destes referentes aos óbitos. Apenas um caso de óbito materno teve relação causal com a vacinação comprovada (causalidade A1), e foi secundário à síndrome trombocitopênica trombótica (TTS) após a vacina AstraZeneca/Fiocruz. Os outros nove óbitos maternos tiveram causalidade C, ou seja, sem relação causal com a vacina, e a maioria por complicações inerentes à gravidez, como a doença hipertensiva específica da gestação (DHEG) e COVID-19. Apesar de algumas limitações em nosso estudo, acreditamos que ele traz dados importantes sobre as vacinas COVID-19 neste grupo aumentando as evidências disponíveis.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Brasil/epidemiología , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Femenino , Humanos , Embarazo , Mujeres Embarazadas , Vacunación , Vacunas/efectos adversos
8.
Stat Methods Med Res ; 31(12): 2323-2337, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36120901

RESUMEN

In sequential testing with binary data, sample size and time to detect a signal are the key performance measures to optimize. While the former should be optimized in Phase III clinical trials, minimizing the latter is of major importance in post-market drug and vaccine safety surveillance of adverse events. The precision of the relative risk estimator on termination of the analysis is a meaningful design criterion as well. This paper presents a linear programming framework to find the optimal alpha spending that minimizes expected time to signal, or expected sample size as needed. The solution enables (a) to bound the width of the confidence interval following the end of the analysis, (b) designs with outer signaling thresholds and inner non-signaling thresholds, and (c) sequential designs with variable Bernoulli probabilities. To illustrate, we use real data on the monitoring of adverse events following the H1N1 vaccination. The numerical results are obtained using the R Sequential package.


Asunto(s)
Subtipo H1N1 del Virus de la Influenza A , Vacunas contra la Influenza , Vacunas , Intervalos de Confianza , Probabilidad , Tamaño de la Muestra , Vacunas/efectos adversos , Ensayos Clínicos Fase III como Asunto , Vacunas contra la Influenza/efectos adversos
9.
Vaccine ; 40(47): 6722-6729, 2022 11 08.
Artículo en Inglés | MEDLINE | ID: mdl-36055876

RESUMEN

INTRODUCTION: Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18-60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. METHODS: The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. RESULTS AND DISCUSSION: A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell's palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Humanos , Brasil/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Programas de Inmunización , Pandemias/prevención & control , Vacunación/efectos adversos , Vacunas/efectos adversos
10.
J Pediatr ; 250: 45-53.e3, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-35948192

RESUMEN

OBJECTIVES: To estimate the risk of recurrence of adverse events following immunization (AEFIs) upon revaccination and to determine among patients with suspected vaccine allergy whether allergy skin test positivity was associated with AEFI recurrence. STUDY DESIGN: This prospective observational study included patients assessed in the Canadian Special Immunization Clinic Network from 2013 to 2019 with AEFIs who required revaccination with the vaccine temporally associated with their AEFI. Participants underwent standardized assessment and data collection. Special Immunization Clinic physicians used guidelines to inform their recommendations. Participants were followed up after revaccination to capture AEFI recurrences. Data were transferred to a central database for descriptive analysis. RESULTS: Overall, 588 participants were assessed for 627 AEFIs; 570 (91%) AEFIs occurred in children <18 years of age. AEFIs included immediate hypersensitivity (130/627; 21%), large local reactions (110/627; 18%), nonurticarial rash (51/627; 8%), seizures (26/627; 4%), and thrombocytopenia (11/627; 2%). Revaccination was recommended to 513 of 588 (87%) participants. Among participants recommended and due for revaccination during the study period, 63% (299/477) were revaccinated. AEFI recurrence was 10% (31/299) overall, 31% (15/49) for large local reactions, and 7% (5/66) for immediate hypersensitivity. No recurrence was serious. Among 92 participants with suspected vaccine allergy who underwent skin testing and were revaccinated, the negative predictive value of skin testing for AEFI recurrence was 96% (95% CI 92.5%-99.5%). CONCLUSIONS: Most individuals with AEFIs were safely revaccinated. Among those with suspected vaccine allergy, skin testing may help determine the safety of revaccination.


Asunto(s)
Hipersensibilidad Inmediata , Hipersensibilidad , Inmunización Secundaria , Inmunización , Vacunas , Niño , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos , Canadá , Hipersensibilidad/etiología , Hipersensibilidad Inmediata/inducido químicamente , Inmunización/efectos adversos , Inmunización Secundaria/efectos adversos , Vacunación/efectos adversos , Vacunas/efectos adversos
11.
Epilepsia ; 63(10): e144-e149, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35943891

RESUMEN

The COVID-19 pandemic led to the development and emergency approval of an array of effective vaccines against SARS-CoV-2. Given the relatively small number of patients included in vaccine trials, postapproval epidemiological surveillance is crucial to detect infrequent vaccine-related adverse events. We conducted a nationwide retrospective descriptive study evaluating the incidence of seizures among recipients of SARS-CoV-2 vaccines in Mexico from December 24, 2020 (date of administration of first doses nationwide) to October 29, 2021. Among 81 916 351 doses of any vaccine that were administered, we documented seizures in 53 patients, of which 31 (60%) were new onset seizures. The incidence rate of seizures per million doses was highest for mRNA-1273 (Moderna) with 2.73 per million, followed by BNT162b2 (Pfizer-BioNTech) with 1.02 per million, and Ad5-nCoV (CanSino) with 1.01 per million. Thus, we found that seizures following SARS-CoV-2 vaccination are exceedingly rare events.


Asunto(s)
COVID-19 , Vacunas , Vacuna BNT162 , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Humanos , México/epidemiología , Pandemias , Estudios Retrospectivos , SARS-CoV-2 , Convulsiones/inducido químicamente , Convulsiones/etiología , Vacunación/efectos adversos , Vacunas/efectos adversos
12.
Vaccine ; 40(33): 4788-4795, 2022 08 05.
Artículo en Inglés | MEDLINE | ID: mdl-35779962

RESUMEN

OBJECTIVE: Describe a case series of vaccine-induced immune thrombotic thrombocytopenia (VITT) after COVID-19 vaccination in Brazil that included ChAdOx1 nCoV-19, Ad26.COV2.S and BNT162b2 vaccines, describing their clinical and laboratory characteristics. METHODOLOGY: Descriptive case series study using Bio-Manguinhos/Fiocruz/AstraZeneca Brazil and National Immunization Program/Ministry of Health (NIP/MoH) data on COVID-19 AEFI surveillance. We obtained patient-level data from pharmacovigilance for AEFI surveillance and used both the NIP/MoH and Bio-Manguinhos/Fiocruz pharmacovigilance databases to create the study database. Thirty-nine cases of suspect VITT were included, 36 after ChAdOx1 nCoV-19, one after BNT162b2 and two after Ad26.COV2.S vaccine. All cases were based on meeting the Brighton Collaboration criteria for VITT. The primary outcomes were clinical and laboratory features, site of thrombosis, and anti-PF4 ELISA, when available. RESULTS: Thirty-nine cases met the criteria, 38 of which were classified as level 1 and one as level 3 according to Brighton Collaboration. Most cases had the central nervous system (CNS) as the main site of thrombosis (21/39) and happened after the vaccine first dose (34/39). The median age of the cases was 41 years old (23 to 86 yo). Most of the cases (61.5%) occurred in women. The median interval between vaccination and onset of symptoms was 8 days (0-37 days). The platelet count and D-dimer count had median values of 34,000/µL and 19,235 µg FEU/L, respectively. The ELISA anti-PF4 antibody was positive in 18 samples. The overall mortality rate was 51% and was higher in cases of CNS thrombosis with intracerebral bleeding. CONCLUSION: Our case series shows that Brazilian VITT cases have similar clinical and laboratory profiles as demonstrated in the literature. Brazil has administered more than 300 million doses of COVID-19 vaccines (more than 110 million from ChAdOx1 nCoV-19). VITT seems to be a very rare but serious adverse event following COVID-19 immunization, especially adenoviral vector immunization.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Trombocitopenia , Trombosis , Ad26COVS1 , Adulto , Vacuna BNT162 , Brasil/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , ChAdOx1 nCoV-19 , Femenino , Humanos , Trombocitopenia/inducido químicamente , Trombocitopenia/epidemiología , Trombosis/inducido químicamente , Trombosis/epidemiología , Vacunación/efectos adversos , Vacunas/efectos adversos
14.
Rev Bras Enferm ; 75(3): e20210132, 2022.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-35137883

RESUMEN

OBJECTIVES: to analyze the effects of nursing professionals' behavior in adverse event following immunization surveillance. METHODS: a cross-sectional study of 384 participants who received vaccines. Information on vaccination history, administered vaccines and vaccination guidelines were analyzed. Descriptive and bivariate analyzes were performed using simple logistic regression (unadjusted Odds Ratio). RESULTS: guidelines on events (PR=1.8; p=0.001) and conducts regarding their occurrence (PR=1.7; p=0.001) are activities that influence adverse event following immunization surveillance. More than half of participants did not receive guidance on the vaccines administered, the events and the conduct in case of an occurrence. Only 38.5% were instructed about the vaccines administered and 40.6% about adverse events. In the presence of an event, 29.9% reported that they sought services for notification. CONCLUSIONS: proper screening, providing guidance on vaccines and adverse events are essential preventive measures to strengthen adverse event following immunization surveillance.


Asunto(s)
Vacunación , Vacunas , Estudios Transversales , Humanos , Inmunización/efectos adversos , Programas de Inmunización , Vacunación/efectos adversos , Vacunas/efectos adversos
15.
Rev Alerg Mex ; 69 Suppl 1: s1-s14, 2022.
Artículo en Español | MEDLINE | ID: mdl-34998305

RESUMEN

Even though the SARS-CoV-2 pandemic represents a historical challenge, science has had an exponential development, and the current vaccination campaigns are proof of this. Unfortunately, along came misinformation and myths regarding their production and their adverse effects. For this reason, we have considered of utter importance to review anaphylaxis, one of the most feared vaccine adverse events.Anaphylaxis can be defined as a life-threatening acute and systemic allergic reaction, with a wide clinical spectrum, which can be explained by many immunological mechanisms, and whose diagnostic complexity demands the fulfillment of strict criteria. Though infrequent, any vaccine has the potential to trigger anaphylaxis. In the United States, for the new SARS-CoV-2 vaccines, rates from 1:200 000 (Pfizer-BioNTech) to 1:360 000 doses (Moderna) have been estimated. Vaccine adverse events can be mediated by hypersensitivity reactions, either allergic or not. Unlike a typical drug allergy, rarely is the active ingredient responsible for the reaction. Therefore, excipients must be considered during the approach to this problem. Vaccine associated anaphylaxis has to be referred to an allergist so as to guarantee the maximum benefit for the patient and improve the vaccines' security profile.


A pesar de la difícil situación que se enfrenta con la actual pandemia de COVID-19, la ciencia ha tenido un desarrollo exponencial. Si bien la inmunización contra esa enfermedad ha sido posible gracias a ello, desafortunadamente se ha acompañado de desinformación y mitos en torno a su fabricación y reacciones adversas. Por tal razón, es importante revisar una de las reacciones adversas a vacunas más temidas para el personal de salud y la población general, la anafilaxia. La anafilaxia se define como una reacción alérgica aguda y sistémica que puede poner en riesgo la vida; se asocia con distintos mecanismos inmunológicos, factores desencadenantes y manifestaciones clínicas. Su diagnóstico puede ser confuso, por lo que se han establecido diferentes criterios. Todas las inmunizaciones tienen el potencial de desencadenar anafilaxia, aunque este evento es poco frecuente. Respecto de las vacunas contra el coronavirus SARS-CoV-2, en Estados Unidos se ha reportado una tasa de anafilaxia de 1:200 000 para la vacuna Pfizer-BioNTech, y de 1:360 000 para la vacuna de Moderna. Al igual que un fármaco, las vacunas pueden presentar efectos adversos mediados por mecanismos de hipersensibilidad, pero a diferencia de lo que sucede con los medicamentos, el principio activo rara vez es el responsable; es más frecuente que las reacciones indeseadas se deban a los excipientes. La sospecha de una anafilaxia secundaria a su aplicación obliga a una oportuna referencia y a un correcto diagnóstico, tanto para el beneficio del paciente como para mejorar el perfil de seguridad de la vacuna.


Asunto(s)
Anafilaxia , COVID-19 , Vacunas , Anafilaxia/inducido químicamente , Vacunas contra la COVID-19 , Humanos , SARS-CoV-2 , Estados Unidos , Vacunas/efectos adversos
16.
Gac Med Mex ; 158(6): 435-441, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36657132

RESUMEN

The Royal Philanthropic Vaccine Expedition (1803-1813) becomes relevant in these pandemic times due to the breadth of its geographical dimension and its nature of a health expedition inspired by a pioneering public health objective of its time: to spread the newly discovered vaccine against smallpox. Undertaken by a small number of participants, the expedition was directed by Francisco Xavier Balmis, who was accompanied, among others, by Antonio Gutiérrez Robredo, his favorite disciple. This research, carried out using primary sources, explores the relationship between both, which went from mutual trust to enmity due to a trivial conflict. The study of previous correspondence and late resolution of the lawsuit filed by Balmis against Gutiérrez allows us to delve into their biographical profiles. As a direct consequence of that litigation, Gutiérrez never went back to Spain, although he became a professor in Mexico; in contrast, Balmis enjoyed honors and recognition in Madrid.


En estos tiempos de pandemia, la Real Expedición Filantrópica de la Vacuna (1803-1813) cobra vigencia por la amplitud de su dimensión geográfica y por su carácter de expedición sanitaria inspirada en un objetivo de salud pública pionero en su época: propagar la recién descubierta vacuna contra la viruela. Acometida por un reducido número de expedicionarios, fue dirigida por Francisco Xavier Balmis, a quien acompañaba, entre otros, Antonio Gutiérrez Robredo, su discípulo predilecto. Esta investigación, realizada con fuentes primarias, explora la relación entre ambos, la cual pasó de la mutua confianza a la enemistad debido a un conflicto nimio. El estudio de la correspondencia previa y la tardía resolución del pleito interpuesto por Balmis contra Gutiérrez permite ahondar en sus perfiles biográficos. Como consecuencia directa de aquel litigio, Gutiérrez nunca retornó a España, aunque llegó a ser catedrático en México; por el contrario, Balmis disfrutó honores y reconocimientos en Madrid.


Asunto(s)
Viruela , Vacunas , Humanos , Masculino , Viruela/historia , Viruela/prevención & control , España , Vacunación , Vacunas/efectos adversos
17.
Pesqui. vet. bras ; 42: e06733, 2022. tab, ilus
Artículo en Inglés | VETINDEX | ID: biblio-1375996

RESUMEN

The aim of the present study was to evaluate the post-vaccinal reaction to two lentogenic vaccine strains of Newcatle disease virus (NDV) and a recombinant turkey herpesvirus (rHVT) vaccine expressing the fusion glycoprotein of NDV in broiler chickens through histomorphometric and histopathologic analyses of the trachea. The experiment involved 245 chicks housed in randomized blocks with three different enclosures under controlled conditions of temperature, light and ventilation. Each enclosure represented a vaccine strain and was divided into groups according to the administration route. Each block also had its own control group composed of unvaccinated birds. The vaccine strains PHY.LMV.42 (PL42) and La Sota (LS) were selected according to the Intracerebral Pathogenicity Index (ICPI) and the rHVT-NDV Serotype 3 strain (ST3) was selected for representing non-NDV infection. At two, four, seven, 14 and 21 days post vaccination, fragments from the middle third of the trachea were collected and submitted to routine histological processing. For the histomorphometric analysis, the slides were photographed, and the thickness of the tracheal mucosa was measured. Statistical analysis involved two-way ANOVA and Tukey's post-hoc test with a 5% significance level. For the histopathological evaluation, lesions were described as to the degree of intensity and distribution. At four and 14 days post vaccination with the LS strain administered by the ocular route, the means of thickening of the tracheal mucosa (20.85±7.31µm and 26.97±5.50µm, respectively) were significantly higher (p<0.05) than for all other strains, which was related to the severe histopathological lesions found in this group, characterized by hyperemia, hyperplasia of the mucous glands, moderate deciliation and multifocal lymphohistiocytic inflammatory infiltrate. At 21 days, broiler chickens vaccinated with the ST3 strain showed more discrete lesions and less thickening of the tracheal mucosa (23.23±7.62µm; p<0.05) in comparison with other studied strains. The lesions found in this group were only hemorrhage, deciliation and mild focal lymphocytic inflammatory infiltrate. The results of the histomorphometry and histopathology of the trachea indicated that vaccination with rHVT-NDV Serotype 3 strain induced lower degree post-vaccine tracheal lesions compared to other vaccine strains analyzed in this study.


Objetivou-se avaliar a reação pós-vacinal de duas estirpes lentogênicas do vírus da doença de Newcastle (VDN) e uma vacina recombinante de herpesvirus de perus (rHVT) que expressa a glicoproteína de fusão de VDN em frangos de corte por meio da histomorfometria e histopatologia da traqueia. Foram utilizados 245 pintos alojados em blocos ao acaso, sendo três galpões distintos em condições controladas de temperatura, luz e ventilação. Cada galpão representou uma cepa vacinal, onde foram divididos por grupos de acordo com a via de administração. Todos os blocos possuíam um grupo controle composto por aves não vacinadas. As cepas vacinais PHY.LMV.42 (PL42) e La Sota (LS) utilizadas foram selecionadas de acordo com o Índice de Patogenicidade Intracerebral (IPIC) e a cepa Sorotipo 3 (ST3), da vacina rHVT-VDN foi selecionada por não representar infecção do VDN. Aos dois, quarto, sete, 14 e 21 dias pós-vacinação, fragmentos do terço médio da traqueia foram coletados e posteriormente processados conforme rotina histológica. Para análise histomorfométrica da mucosa traqueal, as lâminas foram fotografadas e realizadas as mensurações da espessura da mucosa traqueal sendo aplicado teste de análise de variância a dois critérios (ANOVA) e utilizando o post-hoc de Tukey com nível de significância de 5%. Para a avaliação histopatológica foram observadas a presença de lesões microscópicas e estas foram descritas quanto ao grau de intensidade e distribuição. Aos quatro e quatorze dias pós-vacinação com a cepa LS administrada por via ocular, as médias do espessamento da mucosa traqueal (20,85±7,31µm e 26,97±5,50µm, respectivamente) foram significativamente maiores (p<0,05) quando comparada a todas as demais cepas utilizadas, isto se deve às severas lesões histopatológicas encontrados neste grupo, caracterizadas por hiperemia, hiperplasia das glândulas mucosas, deciliação moderada e infiltrado inflamatório linfohistiocitário multifocal moderado. Já aos 21 dias as aves vacinadas com a cepa ST3 apresentaram lesões mais discretas e menor espessamento da mucosa da traqueia (23,23±7,62µm; p<0,05) em comparação às demais cepas estudadas. As lesões encontradas neste grupo foram apenas hemorragia, deciliação e infiltrado inflamatório linfocitário focal discreto. Os resultados da histomorfometria e da histopatologia da traqueia indicou que a vacinação com a rHVT-NDV, cepa Sorotipo 3 induziu menor grau de lesões pós-vacinais na traqueia comparada a outras cepas vacinais analisadas nesse estudo.


Asunto(s)
Animales , Tráquea/efectos de los fármacos , Tráquea/patología , Virus de la Enfermedad de Newcastle/inmunología , Vacunas/efectos adversos , Pollos/virología , Enfermedad de Newcastle/inmunología , Vacunación/efectos adversos
18.
São Paulo; s.n; 2022.
Tesis en Portugués | Coleciona SUS, Sec. Munic. Saúde SP, HSPM-Producao, Sec. Munic. Saúde SP | ID: biblio-1416504

RESUMEN

Este trabalho buscou apresentar um relato de caso de um paciente que evoluiu com Síndrome de Guillain-Barré (SGB) como evento adverso pós vacinação (EAPV) contra a COVID19, CoronaVac, observado no Hospital do Servidor Público Municipal de São Paulo, Brasil em 2021. A SGB é uma doença de caráter autoimune que envolve nervos periféricos. Pessoas que iniciam quadro já estiveram em contato prévio com infecção por Campylobac, Citomegalovírus, vírus ZIKA, H1N1, covid19, dentre outras viroses. Tal relato e discussão sobre o caso se fazem necessários, visto que a SGB é uma afecção neurológica de baixa incidência e EAPV graves, além da escassez de casos documentados desta síndrome como evento adverso vacinal e, mais especificamente, pós vacina contra a COVID-19. O intuito deste trabalho é relatar a evolução do quadro clínico, de exames laboratoriais e de imagem, bem como auxiliar profissionais de saúde na condução de casos semelhantes que possam vir a suceder. A metodologia utilizada foi um estudo observacional descritivo a partir de informações coletadas no prontuário do paciente e do acompanhamento deste dentro do serviço de saúde. A discussão do caso foi amparada por uma revisão de literatura de artigos científicos. Palavras-chave: Vacina contra a covid19. Evento adverso. Síndrome de Guillain-Barré.


Asunto(s)
Humanos , Masculino , Femenino , Vacunas/efectos adversos , Síndrome de Guillain-Barré , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , COVID-19 , Vacunas contra la COVID-19/efectos adversos
19.
Epidemiol. serv. saúde ; 31(3): e2022055, 2022. tab
Artículo en Inglés, Portugués | LILACS | ID: biblio-1404731

RESUMEN

Objetivo: Avaliar a incidência do erro de imunização no serviço público de saúde do estado de Minas Gerais, Brasil. Métodos: Estudo transversal, a partir dos erros notificados no Sistema de Informação do Programa Nacional de Imunização entre 2015 e 2019. Realizaram-se análise descritiva e cálculo da incidência para as macrorregiões de saúde do estado. Resultados: Foram analisadas 3.829 notificações. Crianças menores de 1 ano foram as mais acometidas (39,1%) e a via intramuscular foi responsável por 29,4% dos erros. O erro mais frequente foi a administração de vacina fora da idade recomendada (37,7%). Observou-se maior incidência de erros nas macrorregiões Vale do Aço (26,5/100 mil) e Triângulo do Norte (22,6/100 mil). Conclusão: Os erros de imunização apresentaram incidência heterogênea entre as macrorregiões de Minas Gerais, no período 2015-2019, e a administração de vacinas fora da idade recomendada foi o erro mais notificado.


Objetivo: Evaluar la incidencia de errores de inmunización en el servicio público de salud del estado de Minas Gerais, Brasil. Métodos: Estudio transversal basado en errores notificados en el Sistema de Información del Programa Nacional de Vacunación entre 2015 y 2019. Se realizó un análisis descriptivo y cálculo de la incidencia para las macrorregiones de salud del estado. Resultados: Se analizaron un total de 3.829 notificaciones. Los niños menores de 1 año fueron los más afectados (39,1%) y la vía intramuscular fue responsable del 29,4% de los errores. El error más frecuente fue la administración de la vacuna fuera de la edad recomendada (37,7%). Se observó una mayor incidencia en las macrorregiones Vale do Aço (26,5/100.000) y Triângulo do Norte (22,6/100.000). Conclusión: Los errores de inmunización mostraron una incidencia heterogénea entre las macrorregiones del estado de Minas Gerais de 2015 a 2019 y la administración de vacunas fuera de la edad recomendada fue el error más reportado.


Objective: To evaluate the incidence of immunization errors in the public health service of the state of Minas Gerais, Brazil. Methods: This was a cross-sectional study, based on errors reported on the National Immunization Program Information System between 2015 and 2019. A descriptive analysis and calculation of the incidence for the state's health macro-regions were performed. Results: A total of 3,829 notifications were analyzed. Children younger than 1 year old were the most affected (39.1%) and the intramuscular route accounted for 29.4% of the errors. The most frequently reported error was administration of vaccines outside minimum and maximum recommended ages (37.7%). There was a higher incidence of errors in Vale do Aço (26.5/100,000) and Triângulo do Norte (22.6/100,000) macro-regions. Conclusion: Immunization errors showed a heterogeneous incidence among the macro-regions of the state of Minas Gerais, between 2015-2019, and the administration of vaccines outside minimum and maximum recommended ages was the most frequently reported error.


Asunto(s)
Humanos , Atención Primaria de Salud , Vacunas/administración & dosificación , Vacunas/efectos adversos , Vacunación/estadística & datos numéricos , Brasil/epidemiología , Estudios Transversales , Programas de Inmunización/organización & administración , Seguridad del Paciente , Errores de Medicación/estadística & datos numéricos
20.
Rev Saude Publica ; 55: 70, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34730750

RESUMEN

The coronavirus disease 2019 (COVID-19) pandemic is significantly causing unprecedented clinical, socioeconomic, and public health challenges globally. The successful global administration of effective, safe and sustainable vaccine(s) is widely believed to be crucial in mitigating as well as preventing COVID-19. However, the rising cases of severe adverse events following immunization (AEFI) with COVID-19 vaccines including thrombosis, thrombocytopenia, and in some instances, death have created serious global concerns and could enormously contribute to vaccine hesitancy. Although the complete underlying pathophysiology and immunopathology of the COVID-19 vaccines related to AEFI, including thrombosis and/or anaphylaxis, are yet to be determined, exploring possible immuno-hypersensitivity could be crucial in the mechanisms associated with these reactions, thereby mitigating their occurrences as well as restoring confidence in vaccine administration for a COVID-19 free world.


Asunto(s)
COVID-19 , Trombocitopenia , Trombosis , Vacunas , Brasil , Vacunas contra la COVID-19 , Humanos , SARS-CoV-2 , Vacunas/efectos adversos
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