Importancia de la vigilancia poscomercialización en las vacunas contra SARS-CoV-2 / Importance of post-marketing surveillance of SARS-CoV-2 vaccines

Introducción: La vacunación ha sido una de las intervenciones sanitarias más costo-efectivas, por su impacto en el control de las enfermedades inmunoprevenibles. La pandemia ocasionada por SARS-CoV-2 condujo al desarrollo mundial de más de doscientas vacunas en diferentes fases de investigación con diversas plataformas. Objetivo: Caracterizar la evaluación del control de calidad de las vacunas contra SARS-CoV-2 y los eventos adversos de las aprobadas contra otros agentes patógenos en las diferentes etapas del ensayo preclínico y clínico. Métodos: Se realizó una búsqueda en Google Académico y PubMed/Medline de artículos publicados entre 1969 y marzo de 2021. Se seleccionaron los de mayor relevancia. Desarrollo: Las vacunas se desarrollaron en un corto tiempo ante la pandemia de COVID-19, sin comprometer el adecuado control de los ensayos clínicos. Aunque resultan seguras, no están exentas de eventos adversos; por ello se debe vigilar su seguridad durante el proceso de poscomercialización. Muchas de ellas han comprometido su seguridad. Conclusiones: Las vacunas deben poseer inmunogenicidad, eficacia y seguridad comprobadas. Los eventos adversos pueden surgir en cualquier etapa de la investigación; por tanto, resulta fundamental la vigilancia en la fase de poscomercialización(AU)

Introduction: Vaccination has been one of the most cost-effective health interventions, due to its impact on the control of immunopreventable diseases. The pandemic caused by SARS-CoV-2 led to the worldwide development of more than two hundred vaccines in different phases of research with diverse platforms. Objective: To characterize the quality control assessment of vaccines against SARS-CoV-2 and adverse events of those approved against other pathogens at different stages of preclinical and clinical trials. Methods: We searched Google Scholar and PubMed/Medline for articles published between 1969 and March 2021. The most relevant articles were selected. Development: Vaccines were developed in a short time in the face of the COVID-19 pandemic, without compromising the adequate control of clinical trials. Although they are safe, they are not free of adverse events; therefore, their safety should be monitored during the post-marketing process. Many of them have compromised their safety. Conclusions: Vaccines should possess proven immunogenicity, efficacy and safety. Adverse events can arise at any stage of research; therefore, post-marketing surveillance is essential(AU)

Rotavirus del grupo A circulantes en el Gran Buenos Aires durante los períodos pre- y post-vacunales / Vaccines against rotavirus and impact of their introduction in Argentina

[RESUMEN]. Hacia 2022, más de 100 países habían introducido una de las cuatro vacunas autorizadas para uso mundial contra rotavirus, sin embargo, según modelos matemáticos se estima que es poco probable que la reducción en mortalidad con vacunas orales supere el 40%. Esto se debe a que la mayoría de las muertes asociadas a RVA ocurren en países de ingresos bajos y medianos, donde la efectividad de estas vacunas es menor. Este problema de desempeño en medios de bajo nivel socio-económico, se verifica también en menor efectividad sobre morbilidad y duración de la protección. En este trabajo se discuten los posible factores involucrados en este bajo rendimiento relacionados al patógeno, el huésped y factores ambientales. En Argentina, la vacuna monovalente Rotarix® (GSK) ha sido incorporada en el Calendario Nacional en 2015, sin embargo, aún no existen estudios completos de efectividad. Las observaciones iniciales de nuestro grupo registran una disminución en el número de casos de gastroenteritis aguda requi- riendo hospitalización en el Hospital de Niños Ricardo Gutiérrez (HNRG) a partir del 2015. Para los casos con diagnóstico específico de RVA la diferencia fue cada vez más significativa para los años 2016, 2017 y 2018 (p<<0,05). Comparando las medias anuales en los períodos pre y post vacunales se hallan valores de 104,7 para los años 2008-2014 y de 40,2 para los años 2015-2018 (p<0,05) lo que implica una disminución del 61,6%. También se hallaron diferencias a la baja en el número medio de internaciones por GEA por todas las causas del 19,6%.

[ABSTRACT]. By 2022, more than 100 countries had introduced one of the four vaccines authorized for global use against rotavirus; however, according to mathematical models, it is estimated that the reduction in mortality with oral vaccines is unlikely to exceed 40%. This is because the majority of RVA-associated deaths occur in low- and middle-income countries, where the effectiveness of these vaccines is lower. This performance problem in low socioeconomic environments is also verified in lower effectiveness on morbidity and duration of protection. In this work, the possible factors involved in this low performance related to the pathogen, the host and environmental factors are discussed. In Argentina, the monovalent Rotarix® (GSK) vaccine has been incorporated into the National Schedule in 2015, however, there are still no complete effectiveness studies. The initial observations of our group record a decrease in the number of cases of acute gastroenteritis requiring hospitalization at the Ricardo Gutiérrez Children's Hospital (HNRG) starting in 2015. For cases with a specific diagnosis of RVA, the difference was increasingly significant for the years 2016, 2017 and 2018 (p<<0.05). Comparing the annual averages in the pre- and post-vac- cine periods, values of 104.7 are found for the years 2008-2014 and 40.2 for the years 2015-2018 (p<0.05), which implies a decrease of 61. 6%. Downward differences were also found in the average number of hospitalizations for AGE due to all causes of 19.6%.

Evaluating the real-world vaccine effectiveness using a regression discontinuity design / 中华流行病学杂志

Estimating the actual real-world effectiveness of the vaccine is an essential part of the post-marketing evaluation. This regression discontinuity design (RDD) using observational data is designed to quantify the effect of an intervention when eligibility for the intervention is based on a defined cutoff as age, making it suited to estimate vaccine effects. This approach can avoid the high cost and ethical issues; overcome difficulties in the organization and practice process in randomized controlled trials, which leads to a higher level of causal inference evidence and more realistic results. Here, we describe key features of RDD in general, and then specific scenarios, with examples, to illustrate that RDD are an essential tool for advancing our understanding of vaccine effects.

Respuesta immune humoral asociada a las vacunas contra SARS-CoV-2 en pacientes con artritis reumatoidea: datos del registro SAR-CoVAC / Humoral immune response associated to the vaccines against SARS-CoV-2 in patients with rheumatic arthritis: data from the SAR-CoVAC registry

Introducción: la artritis reumatoidea (AR) y los tratamientos indicados para su manejo pueden afectar la respuesta a la vacuna para SARS-CoV-2. Sin embargo, aún no se cuenta con datos locales. Objetivos: evaluar la respuesta humoral de la vacuna para SARS-CoV-2 y su seguridad en esta población. Materiales y métodos: estudio observacional. Se incluyeron pacientes ≥18 años, con AR ACR/EULAR 2010 que recibieron la vacunación para SARS-CoV-2. Detección de IgG anti-proteína S (kit COVIDAR). Resultados: se incluyeron 120 pacientes con AR. El 24,4% recibió tratamiento con glucocorticoides, 50,9% drogas biológicas y 13,3% inhibidores de JAK (janus kinases). El 6% había tenido infección por SARS-CoV-2 previamente. La vacuna más utilizada en la primera dosis fue Sputnik V (52,9%). El 25% recibió esquemas heterólogos. Luego de la primera dosis, el 59% presentó una prueba no reactiva o indeterminada, y un 18% luego de la segunda dosis. La aplicación de esquemas homólogos de vacuna Sinopharm (63,6% vs 13,3%, p<0,0001), y el uso de abatacept (27,3% vs 5,1%, p=0,005) y rituximab (18,2% vs 0%, p=0,001) al momento de la vacunación se asociaron a un resultado no reactivo o indeterminado. Conclusiones: similar a lo reportado en otras poblaciones internacionales, en esta cohorte, dos de cada 10 pacientes no desarrollaron anticuerpos. Una menor respuesta se asoció con la vacuna Sinopharm y al tratamiento con abatacept y rituximab.

Introduction: rheumatoid arthritis (RA) and its treatments can affect the response to the SARS-CoV-2 vaccine. However, we still do not have local data. Objectives: to evaluate the humoral response of the SARS-CoV-2 vaccine and its safety in this population. Materials and methods: observational study. Patients ≥18 years of age, with RA ACR/EULAR 2010 who had received vaccination for SARS-CoV-2 were included. Detection of anti-protein S IgG (COVIDAR Kit). Results: a total of 120 patients with RA were included. A quarter was receiving glucocorticoids, 50.9% biological drugs and 13.3% JAK inhibitors (janus kinases). Only 6% had a history SARS-CoV-2 infection. The most used vaccine was Sputnik V (52.9%) and 25% received mixed regimenes. After the first dose, 59% had a non-reactive or indeterminate test, and after the second, 18% were still having this result. The application of homologous Sinopharm vaccine regimen (63.6% vs 13.3%, p<0.0001) and the use of abatacept (27.3% vs 5.1%, p=0.005) and rituximab (18.2% vs 0%, p=0.001) at vaccination was associated with a non-reactive or indeterminate result. Conclusions: similar to other international populations, in this cohort, two out of 10 patients did not develop antibodies. A lower response was associated with the Sinopharm vaccine and treatment with abatacept and rituximab.

Reinfection rates among patients previously infected by SARS-CoV-2: systematic review and meta-analysis / 中华医学杂志(英文版)

BACKGROUND@#Asymptomatic or symptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can be followed by reinfection. The protection conferred by prior infection among coronavirus disease 2019 (COVID-19) patients is unclear. We assessed the incidence of SARS-CoV-2 reinfection and the protection effect of previous infection against reinfection.@*METHODS@#We searched PubMed, EMBASE, Cochrane, Scopus, Web of Science, and ClinicalTrials.gov for publications up until the end date of May 1, 2021. The reinfection rate of recovered patients and the protection against reinfection were analyzed using meta-analysis.@*RESULTS@#Overall, 19 studies of 1096 reinfection patients were included. The pooled reinfection rate was 0.65% (95% confidence interval [CI] 0.39-0.98%). The symptomatic reinfection rate was a bit lower (0.37% [95% CI 0.11-0.78%], I2 = 99%). The reinfection rate was much higher in high-risk populations (1.59% [95% CI 0.30-3.88%], I2 = 90%). The protection against reinfection and symptomatic reinfection was similar (87.02% [95% CI 83.22-89.96%] and 87.17% [95% CI 83.09-90.26%], respectively).@*CONCLUSIONS@#The rate of reinfection with SARS-CoV-2 is relatively low. The protection against SARS-CoV-2 after natural infection is comparable to that estimated for vaccine efficacy. These data may help guide public health measures and vaccination strategies in response to the COVID-19 pandemic. High-quality clinical studies are needed to establish the relevant risk factors in recovered patients.

Considerations on vaccines and immunization against COVID-19 for epidemic control in China / 中华预防医学杂志

The Delta variant of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a new global wave of the Coronavirus Disease 2019 (COVID-19) pandemic. COVID-19 vaccines currently available in China show high effectiveness against severe illness and death. However, transmission of the virus is not fully stopped by vaccination alone, therefore, integrated vaccination and non-pharmacological interventions is necessary to prevent and control the epidemic in the near future. Further expanded vaccine coverage of primary doses as well as booster shots in China's domestic population are needed to reduce severe illness and death. In order to provide evidence necessary for adjusting and optimizing immunization strategies and pandemic control measures, it is essential to conduct research on vaccine effectiveness against emerging variants, persistence of vaccine-induced protection, surveillance of adverse event following immunization with large-scale vaccine use, and modelling studies on strategic combinations of vaccination and non-pharmacological interventions.