Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis.

BACKGROUND: The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. METHODS: Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015-19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. RESULTS: An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015-19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01-25.65] to 278.82 [278.20-279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (<0.5 per 100,000 person-years at most sites). Pulmonary embolism was the most common thrombotic event (IR 45.34 [95% CI 44.85-45.84] to 93.77 [95% CI 93.46-94.08] per 100,000 person-years). The IR of myocarditis ranged from 1.60 [(95% CI 1.45-1.76) to 7.76 (95% CI 7.46-8.08) per 100,000 person-years. The IR of several AESI varied by site, healthcare setting, age and sex. The IR of some AESI were notably different in 2020 compared to 2015-19. CONCLUSION: Background incidence of AESIs exhibited some variability across study sites and between pre-pandemic and pandemic periods. These findings will contribute to global vaccine safety surveillance and research.

Assessing the toxicity of contaminated soils using the nematode Caenorhabditis elegans as test organism.

In this study, nine uncontaminated reference soils and 22 contaminated soils with different physico-chemical properties and contamination patterns were tested with a standardized toxicity test, using the nematode, Caenorhabditis elegans, as test organism. Fertility, growth and reproduction of C. elegans in the soils were compared with the exposure in standard soil Lufa St.2.2. C. elegans showed 100% fertility and a very low variability of growth in the reference soils. Although, reproduction varied considerably between the various reference soils, validity criteria (>30 offspring per test organism) were met in all reference soils. Moreover, Lufa St. 2.2 turned out to be a suitable and representative control soil. In order to clearly classify the effects of the polluted soils on C. elegans, toxicity thresholds were derived for nematode fertility (20% inhibition), growth (10% inhibition) and reproduction (40% inhibition) on the basis of the test inherent variability (MDD=minimal detectable difference), as well as their variability between the uncontaminated reference soils (MTI=maximal tolerable inhibition). The contaminated soils showed clear toxic effects on the nematodes, whereas the toxicity was better correlated to organic than to heavy metal contamination in bulk soil. Interestingly, the results of the nematode toxicity test were not well correlated with those of tests with oligochaetes, collembolans and plants, performed with the same soils, showing that the results are not redundant. The toxicity test using C. elegans turned out to be suitable for testing the toxicity of field collected soils and might by a valuable addition to soil test batteries.

The effect of tributyltin-oxide on earthworms, springtails, and plants in artificial and natural soils.

Chemical bioavailability in Organisation for Economic Co-operation and Development (OECD) artificial soil can contrast with bioavailability in natural soils and produce ecotoxicologic benchmarks that are not representative of species' exposure conditions in the field. Initially, reproduction and growth of earthworm and Collembolan species, and early seedling growth of a dicotyledonous plant species, in nine natural soils (with a wide range of physicochemical properties) and in OECD soil were evaluated. Soils that supported reproduction and growth of the test species were then used to investigate the toxicity of tributyltin-oxide (TBT-O). Natural soils caused greater toxicity of TBT-O to earthworms (EC(50) values varied from 0.5 to 4.7 mg/kg soil dry weight [dw]) compared with toxicity in OECD soil (EC(50) = 13.4 mg/kg dw). Collembolans were less sensitive to TBT-O than earthworms in natural soils, with EC(50) values ranging from 23.4 to 177.8 mg/kg dw. In contrast, the toxicity of TBT-O to collembolans in OECD soil (EC(50) = 104.0 mg/kg dw) was within the range of EC(50) values in natural soils. Phytotoxicity tests revealed even greater difference between the effects in natural soils (EC(50) values ranged from 10.7 to 189.2 mg/kg dw) and in OECD soil (EC(50) = 535.5 mg/kg dw) compared with results of the earthworm tests. Studies also showed that EC(50) values were a more robust end point compared with EC(10) values based on comparisons of coefficients of variation. These results show that toxicity testing should include studies with natural soils in addition to OECD soil to better reflect exposure conditions in the field.

[Minimally invasive treatment of monocondylar tibial plateau fractures. Percutaneous reduction and small fragment osteosynthesis]. / Minimal-invasive Versorgung monokondylärer Tibiakopffrakturen. Perkutane Reposition und Kleinfragmentosteosynthese.

BACKGROUND: Treatment of displaced tibial plateau fractures is often complicated by high-energy trauma and soft tissue damage. Therefore, numerous techniques such as indirect or arthroscopically controlled reduction and percutaneous osteosynthesis have been described to reduce the additional surgical trauma. MATERIAL AND METHODS: Twenty-three fractures (AO type 41-B2/3, Schatzker type II-IV) were treated with percutaneous, fluoroscopically guided reduction combined with small fragment osteosynthesis using a radius T-plate. In none of the patient was cancellous bone graft performed. Only in one case was arthrotomy necessary because of uncertain image intensification findings in an obese patient. One revision was done for a 4-mm step caused by an over reduced rim fragment. Fracture healing and full weight bearing were achieved after 8-12 weeks. Neither secondary displacement nor implant loosening was seen under primary functional treatment without immobilization. RESULTS: Functional recovery showed a mean ROM of 114 degrees after 6 weeks and 121 degrees after 3 months. The radius T-plate offers enough stability to allow primary functional treatment due to early recovery of joint motion. Percutaneous reduction and small fragment osteosynthesis is a less invasive approach in the treatment of displaced monocondylar tibial plateau fractures.

Incidence of coronary heart disease and cardiac events in patients undergoing kidney and pancreatic transplantation.

One major cause of graft loss after kidney transplantation or simultaneous kidney and pancreas transplantation is death of the recipient due to cardiac events. Records of 261 patients who underwent sole kidney (group A) or combined kidney-pancreas transplantation (group B) were retrospectively analyzed. Patients were divided into groups with basic cardiac evaluation (chest X-ray, electrocardiogram) and patients with additional diagnostics [echocardiography, exercise stress test, myocardial perfusion test, and coronary angiography (CAG)]. The results of the performed CAGs were as follows: proven coronary artery disease (CAD) in 22 patients (12.43%) in group A and 37 patients (44.05%) in group B; stenosis of one main coronary artery of 70% or greater in 8.47% (group A) and 16.67% (group B) of the patients. Subsequent revascularization procedures were performed in 15 candidates (8.47%) of group A and 11 (13.10%) of group B. The incidence of posttransplant cardiac events (PCE) was lower in recipients in both groups who underwent additional cardiac evaluation. Late postoperative deaths were reported in 3.45% of kidney recipients with no additional evaluation (group A), in 2.06% of patients with further diagnostics (group A), and in only 1.19% of patients with invasive pretransplant evaluation (group B). Patients with known CAD and no further invasive diagnostics or subsequent revascularization are at great risk. PCE were observed in three of seven patients in this subgroup. Careful cardiac evaluation including echocardiography, exercise stress test, myocardial perfusion test, and CAG is associated with a low incidence of PCE.

[Darwinism, materialism and the revolution of 1848 in Germany. On the interaction of politics and science]. / Darwinismus, Materialismus und die Revolution von 1848 in Deutschland. Zur Interaktion von Politik und Wissenschaft.

In recent years, the question of national styles in science has received increasing attention. The different forms of Darwinism that emerged in the nineteenth century provide an impressive example of the role of non-scientific factors in the development of scientific ideas. Although the reception of Darwinian theory has been acknowledged to differ according to distinct national traditions even in Darwin's time, there have been few systematic efforts to understand the underlying causal factors. Usually these explanations have conceived of the relationship of science to its social and political context as a distortion of science by ideology. In contrast to this picture, I attempt to demonstrate here how a scientific research program was situated in a concrete historical context. The German tradition of Darwinism in the nineteenth century will be described as a coalition of political liberalism, materialism, and morphology. Whereas the liberals used Darwinism to give their anti-religious and progressive program a naturalistic foundation, the morphologists appreciated that Darwinian theory allowed them to dispense with the idealistic origins of their research program, and the materialist were provided with a naturalistic explanation of the origin of organic form.

A note on the complex metabolism of danthron infused into the rat.

Danthron infused intravenously in rats shows a complex dose-dependent pattern of metabolism and excretion. The metabolites, particularly the more polar ones, are in general excreted predominantly in bile, to a lesser extent in urine. They can be separated as metabolite groups according to polarity and molecular size on a Sephadex LH 20 column. The present paper describes a further study within a bile-derived metabolite group, which proved to be particularly heterogeneous. It contained more than a dozen metabolites, which were conjugates of four different aglycons including the parent danthron. 1H NMR spectral data for danthron monosulfate and monoglucuronide are also presented.

[Heinrich Georg Bronn and Origin of Species]. / Heinrich Georg Bronn und die Entstehung der Arten.

Heinrich Georg Bronn, one of the leading nineteenth-century palaeontologists was also known as the translator of Charles Darwin's Origin of Species. He undertook his translation soon after the publication of Darwin's work and added a critical post-scriptum. Still in 1857 Bronn had written unambiguously in favour of the constancy of biological species. After the publication of the Origin of Species he thought that in spite of a number of objections which could be brought forward, the future belonged to Darwin's theory and supported with great commitment its spreading. It is puzzling that Bronn did so when he was almost 60 and committed to a religious outlook. The history of the reception of Darwin's doctrine shows that, as a rule, older scientists with such religious worldviews would not support Darwin. The analysis of Bronn's earlier writings and the correspondence between Darwin and Bronn will throw light on the reasons why he represented an exemption. Bronns opinion of Darwin's theory shows the wide gap between the older typologically-inclined natural history and Darwin's evolutionary theory. To conclude, Bronn's translation of the Origin of Species as well as his post-scriptum were of considerable importance for the reception of Darwin's ideas in the german-speaking world.