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      Riesgos de las vacunas contra el SARS-CoV-2: aspectos cognitivos, éticos, sociales y políticos Translated title: Risks of SARS-CoV-2 vaccines: cognitive, ethical, social and political aspects

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          Abstract

          El riesgo es un concepto que suele ser evaluado por los científicos y expertos en salud pública mediante la comparación de probabilidades. Sin embargo, esta perspectiva inscrita en el utilitarismo ético, que considera que la mejor decisión es aquella que tiene menos probabilidad de daño que de beneficio, no contempla aspectos normativos fundamentados en otras perspectivas éticas. La interpretación del origen de las polémicas públicas derivadas de las respuestas de las personas ante los pequeños riesgos de las vacunas con virus atenuados contra el SARS-CoV-2 y la evaluación de las respuestas de las instituciones públicas ante dichas respuestas requieren conocer tanto los aspectos cognitivos que introducen sesgos sistemáticos en la valoración de probabilidades como el marco sociológico, ético y político que contextualiza la gestión de los riesgos en las sociedades modernas.

          Translated abstract

          Risk is a concept that is usually evaluated by scientists and public health experts by comparing probabilities. However, this ethical utilitarian perspective, which considers that the best decision is the one that has less probability of harm than of benefit, does not consider normative aspects based on other ethical perspectives. Interpreting the origin of public controversies arising from people's responses to the small risks of attenuated SARS-CoV-2 vaccines and evaluating the responses of public institutions to these responses requires an understanding of both the cognitive aspects that introduce systematic biases in the assessment of probabilities and the sociological, ethical, and political framework that contextualizes risk management in modern societies.

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          Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination

          Background Several cases of unusual thrombotic events and thrombocytopenia have developed after vaccination with the recombinant adenoviral vector encoding the spike protein antigen of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (ChAdOx1 nCov-19, AstraZeneca). More data were needed on the pathogenesis of this unusual clotting disorder. Methods We assessed the clinical and laboratory features of 11 patients in Germany and Austria in whom thrombosis or thrombocytopenia had developed after vaccination with ChAdOx1 nCov-19. We used a standard enzyme-linked immunosorbent assay to detect platelet factor 4 (PF4)–heparin antibodies and a modified (PF4-enhanced) platelet-activation test to detect platelet-activating antibodies under various reaction conditions. Included in this testing were samples from patients who had blood samples referred for investigation of vaccine-associated thrombotic events, with 28 testing positive on a screening PF4–heparin immunoassay. Results Of the 11 original patients, 9 were women, with a median age of 36 years (range, 22 to 49). Beginning 5 to 16 days after vaccination, the patients presented with one or more thrombotic events, with the exception of 1 patient, who presented with fatal intracranial hemorrhage. Of the patients with one or more thrombotic events, 9 had cerebral venous thrombosis, 3 had splanchnic-vein thrombosis, 3 had pulmonary embolism, and 4 had other thromboses; of these patients, 6 died. Five patients had disseminated intravascular coagulation. None of the patients had received heparin before symptom onset. All 28 patients who tested positive for antibodies against PF4–heparin tested positive on the platelet-activation assay in the presence of PF4 independent of heparin. Platelet activation was inhibited by high levels of heparin, Fc receptor–blocking monoclonal antibody, and immune globulin (10 mg per milliliter). Additional studies with PF4 or PF4–heparin affinity purified antibodies in 2 patients confirmed PF4-dependent platelet activation. Conclusions Vaccination with ChAdOx1 nCov-19 can result in the rare development of immune thrombotic thrombocytopenia mediated by platelet-activating antibodies against PF4, which clinically mimics autoimmune heparin-induced thrombocytopenia. (Funded by the German Research Foundation.)
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            Availability: A heuristic for judging frequency and probability

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              Assessing the age specificity of infection fatality rates for COVID-19: systematic review, meta-analysis, and public policy implications

              Determine age-specific infection fatality rates for COVID-19 to inform public health policies and communications that help protect vulnerable age groups. Studies of COVID-19 prevalence were collected by conducting an online search of published articles, preprints, and government reports that were publicly disseminated prior to 18 September 2020. The systematic review encompassed 113 studies, of which 27 studies (covering 34 geographical locations) satisfied the inclusion criteria and were included in the meta-analysis. Age-specific IFRs were computed using the prevalence data in conjunction with reported fatalities 4 weeks after the midpoint date of the study, reflecting typical lags in fatalities and reporting. Meta-regression procedures in Stata were used to analyze the infection fatality rate (IFR) by age. Our analysis finds a exponential relationship between age and IFR for COVID-19. The estimated age-specific IFR is very low for children and younger adults (e.g., 0.002% at age 10 and 0.01% at age 25) but increases progressively to 0.4% at age 55, 1.4% at age 65, 4.6% at age 75, and 15% at age 85. Moreover, our results indicate that about 90% of the variation in population IFR across geographical locations reflects differences in the age composition of the population and the extent to which relatively vulnerable age groups were exposed to the virus. These results indicate that COVID-19 is hazardous not only for the elderly but also for middle-aged adults, for whom the infection fatality rate is two orders of magnitude greater than the annualized risk of a fatal automobile accident and far more dangerous than seasonal influenza. Moreover, the overall IFR for COVID-19 should not be viewed as a fixed parameter but as intrinsically linked to the age-specific pattern of infections. Consequently, public health measures to mitigate infections in older adults could substantially decrease total deaths. Electronic supplementary material The online version of this article (10.1007/s10654-020-00698-1) contains supplementary material, which is available to authorized users.
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                Author and article information

                Journal
                Gac Sanit
                Gac Sanit
                Gaceta Sanitaria
                SESPAS. Published by Elsevier España, S.L.U.
                0213-9111
                1578-1283
                21 July 2021
                21 July 2021
                Affiliations
                [a ]Servicio de Urgencias Hospitalarias, Hospital General Universitario J.M. Morales Meseguer, Área VI-Vega Media del Segura, Servicio Murciano de Salud, Murcia, España
                [b ]Departamento de Economía Aplicada, Facultad de Economía y Empresa, Universidad de Murcia, Murcia, España
                Author notes
                [* ]Autor para correspondencia.
                Article
                S0213-9111(21)00135-7
                10.1016/j.gaceta.2021.06.007
                8292099
                a812214b-6d93-476c-8ffc-e6357931ad40
                © 2021 SESPAS. Published by Elsevier España, S.L.U.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                : 27 April 2021
                : 29 June 2021
                Categories
                Artículo Especial

                vacunas,medición de riesgo,gestión de riesgos,riesgo acceptable,análisis ético,sociología,formulación de políticas,política de salud,vaccines,risk assessment,risk management,acceptable risk,ethical analysis,sociology,policy making,health policy

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