Propiedad intelectual y derecho de la competencia en el sector farmacéutico durante la pandemia de COVID-19

La pandemia de COVID-19 demostró que las políticas públicas relacionadas con la propiedad intelectual y el derecho de la competencia no fueron adecuadas o suficientemente articuladas para permitir el acceso oportuno de la población a las vacunas de manera equitativa, debido a distorsiones en su fabricación, distribución y venta cuando éstas estuvieron disponibles durante la pandemia. Esta investigación tiene como objetivo analizar, desde una perspectiva jurídica, si los problemas observados se originan en una inadecuada aplicación de la legislación que regula la propiedad intelectual y su relación con otras políticas públicas vinculadas a la competencia, o, eventualmente, en el ejercicio abusivo de tales derechos, y que, como consecuencia, distorsionaría el proceso de competencia en los mercados nacionales y regionales.

The COVID 19 pandemic demonstrated that public policies related to intellectual property and competition law were not adequate or sufficiently articulated to allow timely access to vaccines in an equitable manner, due to distortions in the manufacture, distribution, and sale of COVID-19 vaccines when they were available during the pandemic. This research aims to analyze, from a legal perspective, whether the observed problems originate in an inadequate application of intellectual property legislation and its relationship with other public policies related to competition, or, eventually, in the abusive exercise of such rights, which, as a consequence, would distort the process of competition in national and regional markets.

A pandemia de COVID 19 demostrou que as políticas públicas relacionadas com a propriedade intelectual e o direito de competência não foram adequados ou suficientemente articulados para permitir o acesso oportuno da população às vacinas de maneira equitativa, devido a distorções na fabricação, distribuição e venda de vacinas COVID-19, quando estavam disponíveis durante a pandemia. Esta investigação tem como objetivo analizar, desde uma perspectiva jurídica, se os problemas observados se originam em uma inadequada aplicação da legislação que regula a propriedade intelectual e sua relação com outras políticas públicas vinculadas à competência ou, eventualmente, no exercício abusivo de tais direitos, e que, como consequência, distorceria o processo de competência nos mercados nacionais e regionais.

Navigating the waves in Colombia: a cohort study of inpatient care during four COVID-19 waves

ABSTRACT Introduction: Understanding the intricate dynamics between different waves of the COVID-19 pandemic and the corresponding variations in clinical outcomes is essential for informed public health decision-making. Comprehensive insights into these fluctuations can guide resource allocation, healthcare policies, and the development of effective interventions. This study aimed to compare the characteristics and clinical outcomes of COVID-19 at peak transmission points by including all patients attended during the first four pandemic waves in a referral center in Colombia. Material and methods: In a prospective observational study of 2733 patients, clinical and demographic data were extracted from the Fundacion Valle de Lili's COVID-19 Registry, focusing on ICU admission, Invasive Mechanical Ventilation (IMV), length of hospital stay, and mortality. Results: Our analysis unveiled substantial shifts in patient care patterns. Notably, the proportion of patients receiving glucocorticoid therapy and experiencing secondary infections exhibited a pronounced decrease across waves (p < 0.001). Remarkably, there was a significant reduction in ICU admissions (62.83% vs. 51.23% vs. 58.23% vs. 46.70 %, p < 0.001), Invasive Mechanical Ventilation (IMV) usage (39.25% vs. 32.22% vs. 31.22% vs. 21.55 %, p < 0.001), and Length of Hospital Stay (LOS) (9 vs. 8 vs. 8 vs. 8 days, p < 0.001) over the successive waves. Surprisingly, hospital mortality remained stable at approximately 18-20 % (p > 0.05). Notably, vaccination coverage with one or more doses surged from 0 % during the initial waves to 66.71 % in the fourth wave. Conclusions: Our findings emphasize the critical importance of adapting healthcare strategies to the evolving dynamics of the pandemic. The reduction in ICU admissions, IMV utilization, and LOS, coupled with the rise in vaccination rates, underscores the adaptability of healthcare systems. Hospital mortality's persistence may warrant further exploration of treatment strategies. These insights can inform public health responses, helping policymakers allocate resources effectively and tailor interventions to specific phases of the pandemic.

Immunogenicity of COVID-19 adsorbed inactivated vaccine (CoronaVac) and additional doses of mRNA BNT162b2 vaccine in immunocompromised adults compared with immunocompetent persons

ABSTRACT Inactivated COVID-19 vaccines data in immunocompromised individuals are scarce. This trial assessed the immunogenicity of two CoronaVac doses and additional BNT162b2 mRNA vaccine doses in immunocompromised (IC) and immunocompetent (H) individuals. Adults with solid organ transplant (SOT), hematopoietic stem cell transplant, cancer, inborn immunity errors or rheumatic diseases were included in the IC group. Immunocompetent adults were used as control group for comparison. Participants received two CoronaVac doses within a 28-day interval. IC received two additional BNT162b2 doses and H received a third BNT162b2 dose (booster). Blood samples were collected at baseline, 28 days after each dose, pre-booster and at the trial end. We used three serological tests to detect antibodies to SARS-CoV-2 nucleocapsid (N), trimeric spike (S), and receptor binding domain (RBD). Outcomes included seroconversion rates (SCR), geometric mean titers (GMT) and GMT ratio (GMTR). A total of 241 IC and 100 H adults participated in the study. After two CoronaVac doses, IC had lower SCR than H: anti-N, 33.3% vs 79%; anti-S, 33.8% vs 86%, and anti-RBD, 48.5% vs 85%, respectively. IC also showed lower GMT than H: anti-N, 2.3 vs 15.1; anti-S, 58.8 vs 213.2 BAU/mL; and anti-RBD, 22.4 vs 168.0 U/mL, respectively. After the 3rd and 4th BNT162b2 doses, IC had significant anti-S and anti-RBD seroconversion, but still lower than H after the 3rd dose. After boosting, GMT increased in IC, but remained lower than in the H group. CoronaVac two-dose schedule immunogenicity was lower in IC than in H. BNT162b2 heterologous booster enhanced immune response in both groups.

Factors associated with adherence to the COVID-19 vaccine in pregnant women / Factores asociados a la adherencia a la vacuna contra la COVID-19 en mujeres embarazadas / Fatores associados à adesão da vacina contra a COVID-19 em gestantes

Objective: to identify factors associated with adherence to the COVID-19 vaccine during pregnancy. Method: cross-sectional and analytical study with 348 postpartum women in shared accommodation at the Municipal Maternities of Recife-PE. Data was collected through interviews during the months of June to September 2022. Pearson's Chi-Square or Fisher's Exact tests and the Poisson regression model were applied for statistical analysis. Results: 17.2% of pregnant women adhered to the complete vaccination schedule, and adherence was associated with access to the internet/TV/radio (p-value = 0.011), routine prenatal vaccination (p-value = 0.019), safety of the efficacy of the COVID-19 vaccine and partner support (p-value = 0.020). Postpartum women without access to the internet/TV/radio, and who feel confident about the effectiveness of the vaccine, had higher prevalence rates for adhering to COVID-19 vaccination, with PRs of 2.56 and 3.25, respectively. Conclusion: there was evidence of low adherence to the vaccination schedule against COVID-19 during the gestational period, considering the number of recommended doses and the interval between them. Therefore, professionals in their clinical practice must make pregnant women aware of the importance of immunization and compliance with the vaccination schedule.

Objetivo: identificar factores asociados con la adherencia a la vacuna contra la COVID-19 durante el embarazo. Método: estudio transversal y analítico con 348 puérperas en alojamiento compartido en Maternidades Municipales de Recife-PE. Los datos fueron recolectados por medio de entrevistas durante los meses de junio a septiembre de 2022. Para el análisis estadístico se aplicaron las pruebas Chi-Cuadrado de Pearson o Exacta de Fisher y el modelo de regresión de Poisson. Resultados: el 17,2% de las gestantes cumplió con el esquema completo de vacunación, y la adherencia se asoció con el acceso a internet/televisión/radio (p-valor = 0,011), la vacunación prenatal de rutina (p-valor = 0,019), la seguridad con relación a la eficacia de la vacuna contra la COVID-19 y el apoyo de la pareja (p-valor = 0,020). Las mujeres puérperas sin acceso a internet/televisión/radio, y que se sienten seguras de la eficacia de la vacuna, tuvieron tasas de prevalencia más altas de adherencia a la vacunación contra la COVID-19, con RP de 2,56 y 3,25, respectivamente. Conclusión: se evidenció baja adherencia al esquema de vacunación contra la COVID-19 durante el período gestacional, considerándose el número de dosis recomendadas y el intervalo entre ellas. Por ello, los profesionales en su práctica clínica deben concienciar a las mujeres embarazadas sobre la importancia de la inmunización y del cumplimiento del esquema vacunal.

Objetivo: identificar os fatores associados à adesão da vacina contra a covid-19 no período gestacional. Método: estudo transversal e analítico com 348 puérperas em alojamentos conjuntos das Maternidades Municipais de Recife-PE. Os dados foram coletados por meio de entrevistas durante os meses de junho a setembro de 2022. Aplicou-se para a análise estatística o teste Qui-Quadrado de Pearson ou Exato de Fisher e o modelo de regressão de Poisson. Resultados: 17,2% das gestantes aderiram ao esquema completo de vacinação, e a adesão estava associada ao acesso à internet/TV/rádio (p-valor = 0,011), à vacinação de rotina no pré-natal (p-valor = 0,019), à segurança da eficácia da vacina contra a covid-19 e ao apoio do companheiro/parceria (p-valor = 0,020). As puérperas sem acesso à internet/TV/rádio, e que se sentem seguras com relação à eficácia da vacina, apresentaram maiores prevalências para adesão à vacinação da COVID-19, com RP de 2,56 e 3,25, respectivamente. Conclusão: evidenciou-se uma baixa adesão ao esquema vacinal contra a covid-19 no período gestacional, considerando-se o número de doses recomendadas e o intervalo entre as mesmas. Dessa maneira, os profissionais em sua prática clínica devem conscientizar as gestantes da importância da imunização e do cumprimento do esquema vacinal.

Systematic documentation of the introduction of COVID-19 vaccines in Latin America and the Caribbean / Documentación sistemática de la introducción de vacunas contra la COVID-19 en América Latina y el Caribe / Documentação sistemática da introdução das vacinas contra a COVID-19 na América Latina e no Caribe

ABSTRACT Objective. To document the process of introducing COVID-19 vaccines in a selection of Latin American and Caribbean countries, including the lessons learned and the strengths and weaknesses, and similarities and differences among programs. Methods. This descriptive study is based on a systematic evaluation of the process of introducing COVID-19 vaccines in Argentina, Belize, Brazil, Costa Rica, Panama and Peru. Data were collected through a questionnaire distributed to key stakeholders. Six informants from each of the included countries participated in this study. The period of the study was from December 2021 through September 2022. Results. The main strengths reported by countries were health workers' commitment to delivering vaccinations, evidence-based decision-making, the development of plans for vaccine introduction, the participation of national immunization technical advisory groups, the availability of economic resources and positive actions from the respective Ministry of Health. The main challenges were the actions of antivaccination groups, problems with electronic immunization registries, a lack of vaccines, delays in the delivery of vaccines and the scarcity of health personnel at the local level. Conclusions. Commitment, the participation of multiple sectors, the availability of resources and preparedness planning were some of the many strengths shown by countries introducing COVID-19 vaccines. Weaknesses included third parties' interests, the lack of information systems and difficulty in accessing vaccines and vaccine services. There is a window of opportunity for countries to maintain the good practices that allowed for the processes' strengths and to assess the identified weaknesses to invigorate immunization programs and prepare for future health crises.

RESUMEN Objetivo. Documentar el proceso de introducción de las vacunas contra la COVID-19 en un algunos países de América Latina y el Caribe, incluidas las enseñanzas extraídas y sus puntos fuertes y débiles, así como las similitudes y diferencias entre los distintos programas. Métodos. Este estudio descriptivo se basa en una evaluación sistemática del proceso de introducción de las vacunas contra la COVID-19 en Argentina, Belice, Brasil, Costa Rica, Panamá y Perú. Los datos se recopilaron mediante un cuestionario distribuido a las principales partes interesadas. El estudio contó con la participación de un informante de cada uno de los seis países incluidos. El período de estudio fue de diciembre del 2021 a septiembre del 2022. Resultados. Los países indicaron como puntos fuertes principales el compromiso del personal de atención de salud con la vacunación, la toma de decisiones basada en la evidencia, la formulación de planes para la introducción de las vacunas, la participación de grupos técnicos asesores nacionales sobre inmunización, la disponibilidad de recursos económicos y las medidas favorables adoptadas por respectivos los Ministerios de Salud. Los retos más importantes fueron las acciones de los grupos contrarios a las vacunas, los problemas con los registros electrónicos de vacunación, la falta de vacunas, los retrasos en la entrega de vacunas y la escasez de personal de atención de salud a nivel local. Conclusiones. Se observó que el compromiso, la participación de múltiples sectores, la disponibilidad de recursos y la planificación de la preparación eran algunos de los puntos fuertes de los países que introdujeron las vacunas contra la COVID-19. Los puntos débiles fueron los intereses de terceros, la falta de sistemas de información y las dificultades para acceder a las vacunas y a los servicios de vacunación. Los países disponen ahora de una oportunidad para mantener las buenas prácticas que propiciaron los puntos fuertes de los procesos y evaluar los puntos débiles identificados a fin de fortalecer los programas de inmunización y prepararse para futuras crisis de salud.

RESUMO Objetivo. Documentar o processo de introdução da vacina contra a COVID-19 em alguns países da América Latina e do Caribe, incluindo as lições aprendidas e os pontos fortes e fracos, bem como semelhanças e diferenças entre os programas. Métodos. Este estudo descritivo baseia-se em uma avaliação sistemática do processo de introdução das vacinas contra a COVID-19 na Argentina, em Belize, no Brasil, na Costa Rica, no Panamá e no Peru. Os dados foram coletados por meio de um questionário distribuído às principais partes interessadas. Seis informantes de cada um dos países incluídos participaram do estudo, que foi realizado entre dezembro de 2021 e setembro de 2022. Resultados. Os principais pontos fortes relatados pelos países foram o comprometimento dos profissionais de saúde com a vacinação, a tomada de decisões baseadas em evidências, o desenvolvimento de planos para a introdução de vacinas, a participação de grupos técnicos assessores nacionais sobre imunização, a disponibilidade de recursos econômicos e ações positivas dos respectivos ministérios da Saúde. Os principais desafios foram as ações de grupos antivacina, problemas com os registros eletrônicos de imunização, a falta de vacinas, atrasos na entrega das vacinas e a escassez de pessoal de saúde em nível local. Conclusões. O comprometimento, a participação de vários setores, a disponibilidade de recursos e o planejamento de preparação foram alguns dos muitos pontos fortes demonstrados pelos países ao introduzirem as vacinas contra a COVID-19. Entre os pontos fracos estavam os interesses de terceiros, a falta de sistemas de informação e a dificuldade de acesso às vacinas e aos serviços de vacinação. Há uma janela de oportunidade para que os países mantenham as boas práticas que viabilizaram os pontos fortes dos processos e avaliem os pontos fracos identificados a fim de revigorar os programas de imunização e preparar-se para futuras crises sanitárias.

Headache as the most prevalent post-vaccination adverse event after Covid-19 vaccination / Dor de cabeça como evento adverso pós-vacinação mais prevalente após a vacinação contra Covid-19

BACKGROUND: In 2020, the first vaccines were approved, according to the WHO. However, speculations arose regarding their efficacy and post-vaccination adverse events (AEFV). OBJECTIVE: To evaluate the prevalence of headache as AEFI from the SARSCoV-2 vaccine in Piauí, Brazil. METHODS: This is a quantitative, observational, cross-sectional, and prevalence study. Data were provided by the Post-Vaccination Adverse Event Information System (SI-AEFV), from reported cases from January to September 2021. Data were analyzed, and the research was approved by the UFPI Research Ethics Committee. RESULTS: A total of 2,008 cases were analyzed. Headache was reported in 752 cases (27.99%) as an AEFV after vaccination against SARS-CoV-2. In most cases, patients were from Teresina (67.62%), of brown race/ethnicity (52.67%), female (79.00%), and the majority were not healthcare professionals (54.27%). The most common age of patients, with the original data, was 33 years. After data correction, the most common age was 28 years. The majority of these cases were not severe (96.44%), and the majority of cases were associated with the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine (43.18%).CONCLUSION: Thus, it is concluded from the partial analysis of the results that headache is the most common adverse event after vaccination against SARS-CoV-2. The profile of patients with the most notifications was brown women aged 30 to 40 years who received the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine. Regarding the severity of events, the vast majority were considered non-severe, and no deaths were mentioned, demonstrating the safety of immunobiologicals.

FUNDAMENTO: Em 2020, foram aprovadas as primeiras vacinas, segundo a OMS. No entanto, surgiram especulações quanto à sua eficácia e eventos adversos pós-vacinais (EAPV). OBJETIVO: Avaliar a prevalência de cefaleia como EAPV da vacina SARSCoV-2 no Piauí, Brasil. MÉTODOS: Trata-se de um estudo quantitativo, observacional, transversal e de prevalência. Os dados foram fornecidos pelo Sistema de Informação de Eventos Adversos Pós-Vacinação (SI-AEFV), dos casos notificados no período de janeiro a setembro de 2021. Os dados foram analisados ​​e a pesquisa foi aprovada pelo Comitê de Ética em Pesquisa da UFPI. RESULTADOS: Foram analisados ​​2.008 casos. Cefaleia foi relatada em 752 casos (27,99%) como EAPV após vacinação contra SARS-CoV-2. Na maioria dos casos, os pacientes eram procedentes de Teresina (67,62%), de raça/etnia parda (52,67%), do sexo feminino (79,00%) e a maioria não era profissional de saúde (54,27%). A idade mais comum dos pacientes, com os dados originais, era de 33 anos. Após correção dos dados, a idade mais comum foi 28 anos. A maioria desses casos não foi grave (96,44%), e a maioria dos casos esteve associada à primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca (43,18%).CONCLUSÃO: Assim, conclui-se a partir da análise parcial dos resultados de que cefaleia é o evento adverso mais comum após vacinação contra SARS-CoV-2. O perfil dos pacientes com mais notificações foi de mulheres pardas com idade entre 30 e 40 anos que receberam a primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca. Quanto à gravidade dos eventos, a grande maioria foi considerada não grave e não foram mencionados óbitos, demonstrando a segurança dos imunobiológicos.

Immunization against covid-19 and mortality in hospitalized patients: a retrospective cohort / Imunização contra covid-19 e mortalidade em pacientes hospitalizados: coorte retrospectiva

ABSTRACT OBJECTIVE To evaluate the effectiveness of vaccines developed against covid-19 in reducing mortality in people hospitalized with severe acute respiratory syndrome (SARS) caused by SARS-CoV-2. METHODS This is a retrospective cohort that evaluated risk factors and the effectiveness of the two-dose vaccination schedule in reducing the mortality of people hospitalized for covid-19 in the state of Paraíba from February to November 2021. The explanatory variables were vaccination status, presence of comorbidities, socioeconomic and demographic characteristics. Descriptive analyses and bivariate and multivariable logistic regression were performed. RESULTS Most hospitalizations and deaths occurred until May 2021. The percentage of patients with a complete vaccination schedule was similar across patients admitted to public and private hospitals and higher in residents of less developed municipalities. Multivariable analysis demonstrated that women (OR = 0.896; 95%CI 0.830-0.967) and people admitted to private hospitals (OR = 0.756; 95%CI 0.679-0.842) were less likely to die. Presence of any comorbidity (OR = 1.627; 95%CI 1.500-1.765) and age ≥ 80 years (OR = 7.426; 95%CI 6.309-8.741) were risk factors for death. Patients with complete vaccination schedule at the time of admission were 41.7% less likely to die (OR = 0.583; 95% CI 0.501-0.679) from covid-19 in the adjusted analysis, as compared to unvaccinated patients. CONCLUSIONS The study reveals that immunization was effective in reducing the likelihood of death from covid-19. The results suggest that greater vaccination coverage in the first half of 2021 would prevent thousands of deaths in the country.

RESUMO OBJETIVO Avaliar a efetividade das vacinas desenvolvidas contra a covid-19 na redução da mortalidade em pessoas internadas com síndrome respiratória aguda grave (SRAG) causada pelo SARS-CoV-2. MÉTODOS Trata-se de uma coorte retrospectiva que avaliou fatores de riscos e a efetividade do esquema vacinal com duas doses na redução da mortalidade de pessoas internadas por covid-19 no estado da Paraíba entre fevereiro e novembro de 2021. As variáveis explicativas foram situação vacinal, presença de comorbidades, características socioeconômicas e demográficas. Foram realizadas análises descritivas e regressão logística bivariada e multivariável. RESULTADOS A maior parte das internações e óbitos ocorreram até maio de 2021. O percentual de pacientes com esquema vacinal completo foi similar entre pacientes internados em hospitais públicos e privados e superior em residentes de municípios com menor desenvolvimento. A análise multivariável demonstrou que mulheres (OR = 0,896; IC95% 0,830-0,967) e pessoas internadas em hospitais privados (OR = 0,756; IC95% 0,679-0,842) apresentaram menor chance de morte. A presença de alguma comorbidade (OR = 1,627; IC95% 1,500-1,765) e idade ≥ 80 anos (OR = 7,426; IC95% 6,309-8,741) foram fatores de risco de óbito. Pacientes com esquema vacinal completo no momento da internação apresentaram uma chance 41,7% menor de morte (OR = 0,583; IC95% 0,501-0,679) por covid-19 na análise ajustada, quando comparados com pacientes não vacinados. CONCLUSÕES O estudo revela que a imunização foi efetiva na redução da chance de óbito por covid-19. Os resultados sugerem que uma maior cobertura vacinal no primeiro semestre de 2021 evitaria milhares de mortes no país.

Simultaneous unilateral central retinal vein occlusion and branch retinal artery occlusion after Coronavirus Disease 2019 (COVID-19) mRNA vaccine / Oclusão unilateral simultânea da veia retiniana central e artéria retiniana ramificada após vacina mRNA COVID-19

ABSTRACT A 51-year-old non-obese woman presented with a one-week history of progressive blurry vision within the inferior visual field of her left eye. Her only relevant past medical history was long-standing hypothyroidism and recent vaccination against Coronavirus Disease 2019 (COVID-19) with an mRNA vaccine 12 days before the onset of symptoms. At examination, the anterior segment was unremarkable, but the retinal fundus revealed a central retinal vein occlusion associated with a branch retinal artery occlusion of the superior temporal branch in her left eye. Ancillary tests to rule out thrombophilia, hyperviscosity, hypercoagulability, or inflammation were negative. Ultrasound tests were also negative for a cardiac or carotid origin of the branch retinal artery occlusion. At two-month follow-up, no new retinal vascular occlusive events were observed. Although the best-corrected visual acuity at presentation was 8/10 in the left eye, the final best-corrected visual acuity remained 3/10.

RESUMO Uma mulher de 51 anos, não obesa, apresentou história de uma semana de visão embaçada progressiva no campo visual inferior do olho esquerdo. Seu único histórico médico anterior relevante era hipotireoidismo de longa data e uma recente vacinação contra a Doença de Coronavírus 2019 (COVID-19), com vacina de mRNA, 12 dias antes do início dos sintomas. O exame mostrou segmento anterior normal, mas o fundo da retina revelou uma oclusão da veia central da retina associada a uma oclusão de ramo arterial da retina do ramo temporal superior no olho esquerdo. Testes auxiliares para descartar trombofilia, hiperviscosidade, hipercoagulabilidade ou inflamação apresentaram resultados negativos. Testes de ultrassom também foram negativos quanto a uma origem cardíaca ou da carótida da oclusão do ramo da artéria da retina. Após dois meses de acompanhamento, nenhum novo evento vascular oclusivo retiniano foi observado. Embora, a acuidade visual melhor corrigida na apresentação tenha sido de 8/10 no olho esquerdo, a acuidade visual final melhor corrigida permaneceu em 3/10.

Macular perfusion changes in people administered two types of COVID-19 vaccines: optical coherence tomography angiography study

ABSTRACT Purpose: To evaluate macular chorioretinal flow changes on optical coherence tomography angiography, in participants who received inactivated and messenger RNA (mRNA) vaccines to prevent coronavirus disease 2019 (COVID-19). Methods: In this prospective cohort study, healthy participants who received two doses of an inactivated COVID-19 vaccine (CoronaVac) and then one dose of an mRNA vaccine (BNT162b2) were examined before and after each vaccination. Ophthalmologic examination and imaging with optical coherence tomography angiography were performed during each visit. We evaluated vascular densities in the superficial and deep capillary plexuses in foveal, parafoveal, and perifoveal areas; the foveal avascular zone; and choriocapillaris flows (in 1- and 6-mm-diameter areas). Results: One eye in each of the 24 participants was assessed. Superficial capillary plexus vascular densities in the parafoveal area were significantly lower after the second dose of the CoronaVac vaccine than after the first dose. In the deep capillary plexus, vascular attenuation was observed only in the parafoveal region after the first CoronaVac dose. However, in all regions, the deep capillary plexus vascular densities and subfoveal choriocapillaris flow were significantly decreased after the second CoronaVac dose. After the BNT162b2 dose, the superficial capillary plexus vascular densities, the deep capillary plexus vascular densities, and subfoveal choriocapillaris flow of most regions were significantly lower than those before vaccinations. Conclusion: Vascular attenuation, observed particularly after the second dose of the CoronaVac vaccine, may explain the pathogenesis of postvaccine ocular ischemic disorders reported in the literature. However, these disorders are extremely rare, and the incidence of thrombotic events caused by COVID-19 itself is higher.

Vaccine effectiveness in preventing deaths in people with severe acute respiratory syndrome due to COVID-19 in Blumenau, Brazil, 2021 / Efectividad de las vacunas en la prevención de la muerte por síndrome respiratório agudo grave por covid-19 en Blumenau, Brasil, 2021 / Efetividade vacinal na prevenção de óbitos em pessoas com síndrome respiratória aguda grave por covid-19 em Blumenau, 2021

ABSTRACT Objective to analyze the vaccine effectiveness in preventing deaths attributed to severe acute respiratory syndrome due to COVID-19 (SARS/COVID-19) in adults and the elderly, in Blumenau, state of Santa Catarina, Brazil, 2021. this was a population-based study conducted among individuals aged 20 years and older hospitalized with SARS/COVID-19; each death due to SARS/COVID-19 was considered a "case", and every survivor was considered a "control"; the association between vaccination status and the outcome of "death" was estimated using logistic regression, and vaccine effectiveness was estimated as (1-OR)*100. The study included 1,756 cases of SARS/COVID-19 (59.2% male, mean age of 56 years, 50.4% with elementary education, 68.4% with comorbidities and 39.1% in intensive care), of whom 398 died (cases) and 1,358 survived (controls); vaccine effectiveness was 74% and 85% (20-59 years old) and 72% and 75% (≥ 60 years old), respectively, for those who were partially vaccinated and fully vaccinated. Conclusion vaccines proved to be effective in reducing case fatality ratio due to SARS/COVID-19 in individuals ≥ 20 years old.

RESUMEN Objetivo analizar la efectividad de la vacuna para prevención de muertes por SRAG-COVID en adultos y ancianos de Blumenau, Santa Catarina, Brasil, 2021. Método estudio de base poblacional con personas hospitalizadas por SRAG-COVID mayores de 20 años; las muertes por SRAG-COVID se consideraron casos y todos los supervivientes, controles; la asociación entre el estado de vacunación y la muerte se estimó mediante regresión logística; la efectividad de la vacuna se estimó por (1-OR)*100. Resultados participaram do estudo 1.756 casos de SRAG-COVID (59,2% del sexo masculino, edad media de 56 años, 50,4% con estudios primarios, 68,4% con comorbilidades y 39,1% en cuidados intensivos), dos quais 398 foram a óbito (casos) e 1.358 sobreviveram (controles); la efectividad de la vacuna fue del 74% y el 85% (20 a 59 años) y del 72% y el 75% (60 y más años), entre los que tenían vacunación parcial y completa, respectivamente. Conclusión las vacunas fueran efectivas para reducir la letalidad del SRAG-covid.

RESUMO Objetivo Analisar a efetividade vacinal na prevenção de óbitos atribuídos a síndrome respiratória aguda grave por covid-19 (SRAG-covid) em adultos e idosos, em Blumenau, Santa Catarina, Brasil, 2021. Métodos Estudo populacional, entre maiores de 20 anos de idade internados por SRAG-covid; considerou-se "caso" cada óbito por SRAG-covid, e "controle", todo sobrevivente; estimou-se a associação entre a condição vacinal e o desfecho "óbito" por regressão logística, e a efetividade vacinal, por (1-OR)*100. Resultados Participaram do estudo 1.756 casos de SRAG-covid (59,2% do sexo masculino, idade média de 56 anos, 50,4% com ensino fundamental, 68,4% com comorbidades e 39,1% em cuidado intensivo), dos quais 398 foram a óbito (casos) e 1.358 sobreviveram (controles); a efetividade vacinal foi de 74% e 85% (20-59 anos) e de 72% e 75% (≥ 60 anos), respectivamente, para quem possuía vacinação parcial e vacinação completa. Conclusão Vacinas mostraram-se efetivas na redução da letalidade por SRAG-covid em indivíduos com idade ≥ 20 anos.

Complications following COVID-19 infection or vaccination in Libyan International Medical University students and their Families

Coronavirus disease 2019 (COVID-19) caused by a novel strain of coronavirus belonging to the genus Beta coronavirus named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged as a major pandemic worldwide. This contagious virus had spread in many different forms, and patients have demonstrated a wide range of symptoms, ranging from moderate to severe illness. This study aims to highlight the important associations between SARS-CoV-2 infection, vaccination, and possible complications at the Libyan International Medical University, Benghazi. This crosssectional survey was conducted among students and their families at Libyan International Medical University in Benghazi, Libya. Among the 100 participants, 72% were between the ages of 18 and 39. Up to (59%) of participants were men. As for the infection with COVID-19, 77% of participants were infected. Most of the participants had no chronic diseases (69%); however, the most common chronic disease was diabetes mellitus (13%). 82% of participants were vaccinated; the most common types of vaccines administered were Sinopharm and Sputnik V (24%). Following vaccination, 71% of participants had no COVID-19 infection, while 29% did get the infection. Regarding this study, after COVID-19 infection, 66% of participants had no complications; however, 17% had pulmonary complications, which was the most common complication among the participants. As for the complications following the vaccination, 81% of participants had none, while there were pulmonary and neurological complications in 7­6%. The results of the study showed that the most frequent complications noticed among the participants following the COVID-19 infection and vaccination were pulmonary and neurological complications.

Aceptación y reticencia a las vacunas contra COVID-19 en ingresantes a una universidad pública peruana durante la tercera ola pandémica

Introducción. Los estudiantes universitarios influyen en las decisiones de su familia y comunidad a favor de la vacunación. Objetivo. Identificar las principales razones para la aceptación o reticencia vacunal contra COVID-19 en ingresantes a una universidad pública. Métodos. Estudio transversal en una muestra de 408 estudiantes. Se preguntó si había completado las tres dosis de vacuna contra COVID-19 y la principal razón para la aceptación o reticencia vacunal. Se realizó un análisis descriptivo, se aplicó la prueba chi cuadrado y exacta de Fisher. Resultados. El 85,5% aceptó la vacuna principalmente por no querer contagiar a familiares (38,1%) y no querer enfermarse (27,8%). El 14,5% fue reticente, especialmente por prolongados tiempos de espera en vacunatorios (37,3%) y lejanía de los centros de vacunación (13,6%). Conclusiones. En los universitarios estudiados, el temor a la enfermedad impulsó la aceptación de la vacuna contra COVID-19 y la inaccesibilidad a los servicios de salud generó la reticencia.

Introduction. University students influence their family and community decisions in favor of vaccination. Objective. To identify the main reasons for COVID-19 vaccine acceptance or hesitancy among university entrants. Methods. A cross-sectional study in a sample of 408 students. We asked whether the student had completed the three doses the COVID-19 vaccine and the main reason for vaccine acceptance or hesitancy. A descriptive analysis was performed, the chi-square test and Fisher's exact were applied. Results. 85.5% accepted vaccination mainly because they did not want to infect family members (38.1%) and did not want to get sick (27.8%). 14.5% were hesitancy especially due to long waiting times in vaccination centers (37.3%) and distance from vaccination centers (13.6%). Conclusions. In the university students studied, the fear of disease drove COVID-19 vaccine acceptance and inaccessibility to health services generated vaccine hesitancy among university entrants.

Vacuna contra la COVID-19 y menstruación, desde el desconocimiento a la información: revisión sistemática / Vaccine against COVID-19 and menstruation, from ignorance to information: a systematic review

La creación de una vacuna para enfrentar la pandemia de COVID-19 conllevó un vacío de información sobre las posibles alteraciones del ciclo menstrual. El objetivo fue verificar las posibles alteraciones que se pudiesen haber generado en el ciclo menstrual de las mujeres posterior a la inoculación de la vacuna contra la COVID-19. Se realizó una revisión sistemática en las bases bibliografías Medline, Medline Complete, LILACS, CINAHL y ScIELO, utilizando los descriptores “Women”, “Woman”, “Fertile period”, “Vaccination”, “Mass vaccination”, “Immunization”, “COVID-19 vaccines”, “SARS-CoV-2 infection”, “COVID-19”, “Menstrual cycle”, “Menstruation”, “Endometrial cycle”, “Dysmenorrhea” y “Menstruation disturbances”. Mediante la utilización del protocolo PRISMA, de los 319 artículos localizados, 17 fueron incluidos en el análisis. La mayoría de los estudios incluyeron, principalmente, las vacunas Pfizer, Moderna, AstraZeneca y Johnson&Johnson/Janssen con una a tres dosis administradas. El porcentaje de ciclos menstruales alterados fue del 8,0% al 77,8%, y la alteración con mayor frecuencia referida fue la duración del ciclo menstrual, que fue desde 0,3 hasta 12 días de retraso de la menstruación. Todos los estudios refieren cambios en el ciclo menstrual con diversas prevalencias, con y sin significación estadística; sin embargo, también concluyen que estas alteraciones son reversibles y en un corto periodo de tiempo.

The creation of a vaccine to face the COVID-19 pandemic, led to an information gap on possible alterations of the menstrual cycle. The objective was to verify the possible alterations that could have been generated in the menstrual cycle of women, after the inoculation of the vaccine against COVID-19. A systematic review was carried out in the Medline, Medline Complete, LILACS, CINAHL and ScIELO bibliographic databases, using the descriptors “Women”, “Woman”, “Fertile period”, “Vaccination”, “Mass vaccination”, “Immunization”, “COVID-19 vaccines”, “SARS-CoV-2 infection”, “COVID-19”, “Menstrual cycle”, “Menstruation”, “Endometrial cycle”, “Dysmenorrhea” and “Menstruation disturbances”. Using the PRISMA protocol, of the 319 articles located, 17 were included in the analysis. Most of the studies mainly included the Pfizer, Moderna, AstraZeneca and Johnson&Johnson/Janssen vaccines with one to three doses administered. The percentage of altered menstrual cycles ranged from 8.0% to 77.8%, and the most frequently reported alteration was the length of the menstrual cycle, which occurred from 0.3 to 12 days late in menstruation. All the studies refer to changes in the menstrual cycle with different prevalences, with and without statistical significance; however, the same studies also conclude that these alterations are reversible and in a short period of time.

Perfil de pacientes adultos hospitalizados por COVID-19 antes y después de la introducción de las vacunas contra SARS-CoV-2 / Profile of adult patients hospitalized with COVID-19 before and after the introduction of vaccines against SARS-CoV-2

INTRODUCCIÓN: La introducción progresiva de vacunas contra SARS-CoV-2 a partir de 2021, priorizando grupos de mayor edad, podría implicar un cambio en el perfil de pacientes hospitalizados por COVID-19 en el tiempo. OBJETIVO: Comparar las características y evolución de pacientes adultos hospitalizados por COVID-19 en un período anterior en 2020 (PER1) y otro posterior al inicio de la vacunación masiva contra SARS-CoV-2 (PER2). PACIENTES Y MÉTODOS: Se registró edad, género, comorbilidades, complicaciones y evolución de los pacientes hospitalizados por COVID-19 en una clínica privada, en Santiago, Chile. Se calculó el puntaje de gravedad y riesgo nutricional. RESULTADOS: En PER2, los pacientes fueron de menor edad, pero con comorbilidades similares al PER1, excepto por mayor malnutrición por exceso. Los pacientes del PER2 no vacunados requirieron más ventilación mecánica (38,9 vs. 14,3%, p = 0,03) y evolucionaron más gravemente (puntaje 6) que aquellos adecuadamente inmunizados (puntaje 5, p = 0,048). Las variables que más predijeron mortalidad fueron edad > 60 años (OR 28.995) y presencia de riesgo nutricional (OR 5.246). DISCUSIÓN: El cambio en el perfil y evolución de los pacientes hospitalizados con COVID-19 está asociado con la secuencia de priorización de vacunas contra SARS-CoV-2, cuyo efecto redujo las hospitalizaciones y gravedad de COVID-19 en adultos mayores.

BACKGROUND: During the COVID-19 pandemic, the early prioritization of SARS-CoV-2 vaccines for older adults may have affected the characteristics of hospitalized COVID-19 patients over time. AIM: To compare the clinical characteristics and outcomes of adult patients admitted for COVID-19 before (PER1) and after (PER2) the initiation of mass vaccination for SARS-CoV-2. METHODS: Data on age, gender, comorbidities, complications, and outcomes of adult patients hospitalized for COVID-19 in a private clinic of Santiago, Chile, were collected. Scores for COVID-19 severity and nutritional risk were calculated. RESULTS: In PER2, patients were younger but had similar comorbidities, except for a higher prevalence of overweight and obesity compared to PER1. Unvaccinated COVID-19 patients in PER2 required more invasive ventilatory support (38.9% vs. 14.3%, p = 0.03) and had a higher severity score (six) than vaccinated patients (five, p = 0.048). The variables that best predicted mortality were age > 60 years (OR 28,995) and the presence of nutritional risk (OR 5,246). DISCUSSION: Changes in the profile and outcomes of hospitalized patients during the COVID-19 pandemic are associated with the prioritization of SARS-CoV-2 vaccines and their protective effect in reducing hospitalizations and disease severity in older adults.

The impact of bolsonarismo on COVID-19 vaccination coverage in Brazilian municipalities / O impacto do bolsonarismo na cobertura vacinal de Covid-19 em municípios brasileiros

ABSTRACT The immunization campaign against COVID-19 started in Brazil in January 2021 after strong pressure from society on the federal government, which had created a series of ideological obstacles against vaccines, especially those produced with Chinese inputs. This article analyzes the impact of far-right ideology on the spatial distribution of vaccine coverage against COVID-19 in Brazilian municipalities. By means of hierarchical models, it was identified that, maintaining constant socio-demographic characteristics and the structures of the Unified Health System, the degree of bolsonarismo in the municipalities had a negative impact on the coverage rates of the first, second and, especially, of the third dose.

RESUMO A campanha de imunização contra a Covid-19 foi iniciada no Brasil em janeiro de 2021 após forte pressão da sociedade sobre o governo federal, que havia criado uma série de empecilhos ideológicos às vacinas, sobretudo as produzidas com insumos chineses. Este artigo analisa o impacto da ideologia de extrema direita na distribuição espacial da cobertura vacinal contra Covid-19 nos municípios brasileiros. Por meio de modelos hierárquicos multiníveis de dois estágios identificou-se que, mantidas constantes as características sociodemográficas e as estruturas do Sistema Único de Saúde, o grau de bolsonarismo nos municípios impactou negativamente as taxas de cobertura da primeira, da segunda e, especialmente, da terceira dose da vacina.

COVID-19 en pacientes con esclerosis múltiple: estudio observacional retrospectivo en un centro de referencia colombiano / COVID-19 in patients with multiple sclerosis: retrospective observational study in a reference center in Colombia

Introducción: En Colombia, la información sobre la frecuencia de presentación de la enfermedad por CO-VID-19 y sus desenlaces en personas con esclerosis múltiple (EM) es prácticamente inexistente. El objetivo de este estudio es describir la frecuencia, las características y los factores relacionados con la infección por COVID-19 en una muestra de pacientes con EM en Colombia. Materiales y métodos: Análisis descriptivo y retrospectivo de pacientes diagnosticados con criterios de esclerosis múltiple que acudieron a nuestro centro entre junio y octubre del año 2021. Los pacientes proporcionaron información sobre la infección por SARS-CoV-2 y su vacunación. Se analizaron los factores relacionados con la infección por COVID-19 mediante modelos de regresión logística binomial uni y multivariable. Resultados: Se analizaron 240 pacientes, de los cuales el 71 % eran mujeres, con una edad promedio de 34 años. La mayoría estaban en tratamiento con terapias modificadoras de la enfermedad y más del 80 % estaban vacunados. Sesenta y nueve pacientes declararon haber tenido COVID-19. En los modelos multivariables, la edad (OR 0,96; IC 95 % 0,93-0,99) fue el único factor asociado con una menor probabilidad de infección por COVID-19. Discusión: La infección por COVID-19 en pacientes con EM en Colombia parece ser independiente de las variables clínicas y de tratamiento y parece estar asociada con la menor edad. Conclusiones: Se requieren más estudios para evaluar el comportamiento del COVID-19 en pacientes con EM en el contexto colombiano.

Introduction: The information about the frequency of COVID-19 and its outcomes in people with Multiple Sclerosis (MS) in Colombia is practically non-existent. We aimed to describe the frequency characteristics and factors associated with of COVID-19 in a sample of patients with MS. Materials and methods: Descriptive and retrospective analysis of patients diagnosed with Multiple Sclerosis criteria who attended our center between June and October 2021. Patients provided information about SARS-CoV-2 infection and their vaccination. COVID-19 determinants were analyzed using uni-and multivariable binomial logistic regression models. Results: 240 patients were analyzed, of whom 71% were women, with a mean age of 34 years. The majority of patients were on disease-modifying therapies and over 80 % were vaccinated. 69 patients reported having had COVID-19. In multivariable models, age (OR 0.96; 95 % CI 0.93-0.99) was the only factor associated with a lower odds of COVID-19 infection. Discussion: COVID-19 infection in patients with MS in Colombia appears to be independent of clinical and treatment variables, and it appears to be associated with younger age. Conclusions: More studies are needed to assess the behavior of COVID-19 in MS patients from Colombia.

Inmunización con vacunas ARN mensajero contra la COVID-19 en pacientes adolescentes con antecedente de síndrome inflamatorio multisistémico: serie de casos / Immunization with messenger RNA vaccines against COVID-19 in adolescents with a history of multisystem inflammatory

Los niños cursan mayormente la infección por el virus SARS-CoV-2 en forma leve. Sin embargo, de forma muy infrecuente algunos pueden desarrollar una patología con marcada gravedad denominada síndrome inflamatorio multisistémico en niños relacionado temporalmente con COVID-19 (SIM-C). Dado su reciente surgimiento, aún hay aspectos de su fisiopatología que se desconocen. La posibilidad de recidiva en caso de reinfección o ante la vacunación contra SARS-CoV-2 son nuevos interrogantes a los que nos enfrentamos. Reportamos una serie de casos de 4 pacientes adolescentes que cursaron SIM-C y meses después han sido vacunados contra SARS-CoV-2 con plataformas ARN mensajero (ARNm) sin presentar recurrencia de la enfermedad ni efectos adversos cardiológicos

In most cases, children with SARS-CoV-2 have a mild infection. However, very rarely, some children may develop a severe disease called multisystem inflammatory syndrome in children temporally associated with COVID-19 (MIS-C). Given its recent emergence, some aspects of its pathophysiology are still unknown. The possibility of recurrence in case of reinfection or SARS-CoV-2 vaccination are new questions we are facing. Here we report a case series of 4 adolescent patients who developed MIS-C and, months later, received the SARS-CoV-2 vaccine with messenger RNA (mRNA) platforms without disease recurrence or cardiac adverse events.

COVID-19 vaccination in children: a public health priority

Abstract Objective: Covid-19 had a direct impact on children's health. The aim of this review was to analyze epidemiological and clinical data, the consequences of the pandemic, and vaccination aspects in this group. Sources of data: The searches were carried out from January 2020 to November 2022, in the MEDLINE databases (PubMed) and publications of the Brazilian Ministry of Health and the Brazilian Society of Pediatrics. Summary of findings: Covid-19 has a mild presentation in most children; however, the infection can progress to the severe form and, in some cases, to MIS-C. The prevalence of the so-called long Covid in children was 25.24%. Moreover, several indirect impacts occurred on the health of children and adolescents. Vaccination played a crucial role in enabling the reduction of severe disease and mortality rates. Children and adolescents, as a special population, were excluded from the initial clinical trials and, therefore, vaccination was introduced later in this group. Despite its importance, there have been difficulties in the efficient implementation of vaccination in the pediatric population. The CoronaVac vaccines are authorized in Brazil for children over three years of age and the pediatric presentations of the Pfizer vaccine have shown significant effectiveness and safety. Conclusions: Covid-19 in the pediatric age group was responsible for the illness and deaths of a significant number of children. For successful immunization, major barriers have to be overcome. Real-world data on the safety and efficacy of several pediatric vaccines is emphasized, and the authors need a uniform message about the importance of immunization for all children.

Covid-19 em Viçosa-MG: análise quantitativa, vacinal, etária e de gênero das pessoas infectadas e os impactos da vacinação / Covid-19 in Viçosa-MG: quantitative, vaccine, age, and gender analysis of infected people and the impacts of vaccination

Este estudo teve como objetivo analisar o número de casos e óbitos por Covid-19 em relação a gênero e idade, quantidade total de vacinas aplicadas e relação entre a aplicação das vacinas e número de mortes, de janeiro a novembro de 2021, na cidade e região de Viçosa, Minas Gerais. Os dados foram fornecidos pelo Setor de Vigilância Epidemiológica do município e pelos boletins diários da prefeitura. Em média, houve mais de mil casos de infectados/mês de janeiro a julho, a maior parte adultos do gênero feminino. A mortalidade também foi maior entre as mulheres. Foi registrada queda do número de casos e de mortes coincidente com a aplicação da primeira dose de vacina em pessoas sem comorbidades e com início de aplicação da segunda dose nos grupos prioritários. Tal achado indica a importância da imunização coletiva no controle da pandemia.

This study aimed to analyze the number of cases and deaths from Covid-19 in relation to gender and age, the total vaccines applied, and the relationship between the vaccine application and the number of deaths between January and November 2021, in the municipality and region of Viçosa, state of Minas Gerais. Data were provided by the Epidemiological Surveillance Sector of the municipality of Viçosa and by the Daily Bulletins, published by the city hall. On average, there were more than 1,000 cases per month from January to July, mostly female adults. Mortality was also higher for females. There was a drop in the number of cases and deaths, coincident with the application of the first dose of vaccine in people without comorbidities and the initial period of application of the second dose in priority groups, indicating the importance of collective immunization to control the pandemic.