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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. 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. 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. 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.

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.

Consumer purchase data (CPD) is a promising instrument to assess the impact of purchases on health, but is limited by the need for manual scanning, a lack of access to data from multiple retailers, and limited information on product data and health outcomes. Here we describe the My Purchases cohort, a web-app enabled, prospective collection of CPD, covering several large retail chains in Denmark, that enables linkage to health outcomes. The cohort included 459 participants as of July 03, 2023. Up to eight years of CPD have been collected, with 2,225,010 products purchased, comprising 223,440 unique products. We matched 88.5% of all products by product name or item number to one generic food database and three product databases. Combined, the databases enable analysis of key exposures such as nutrients, ingredients, or additives. We found that increasing the number of retailers that provide CPD for each consumer improved the stability of individual CPD profiles and when we compared kilojoule information from generic and specific product matches, we found a median modified relative difference of 0.23. Combined with extensive product databases and health outcomes, CPD could provide the basis for extensive investigations of how what we buy affects our health.

Cryoablation is a well-established treatment option, proven to be successful in treating local renal cell carcinoma (RCC). We treated a 67-year-old man in an outpatient setting with late onset of a 25 mm solitary soft-tissue metastasis of from RCC with cryoablation. The treatment was performed under sedation and in local anaesthesia. There were no complications during the procedure. The patient did not experience any adverse effects to the treatment. He was able to resume his normal daily routines the day after his treatment. A follow-up CT scan at 3, 8 and 12 months after treatment reported sufficient cryoablation and no sign of recurrence or other metastases.

The environmental risk assessment of metals in the soil compartment is based mainly on tests performed in Organization for Economic Cooperation and Development (OECD) artificial soil, but ecologically, the use of natural soils would be more relevant. In this contribution, the reproduction and growth of three standard species (an earthworm, a collembolan, and a dicotyledonous plant, respectively) was evaluated in nine natural soils (covering a wide range of pH values, organic matter content, texture, and so on) and in OECD artificial soil. Afterward, the effects of the model chemical zinc nitrate were assessed in all soils that were identified as being suitable for these species. The test results indicate that the toxicity of zinc nitrate can be higher by a factor of approximately four compared to artificial soil for invertebrates (earthworms and collembolans), whereas plants are only slightly more sensitive in some natural soils than in artificial soil. When comparing the different endpoints, it could be confirmed that the median effective concentration (EC50) is the most robust compared to the highly uncertain 10% effective concentration. Decreasing toxicity of zinc nitrate to collembolans was significantly correlated with an increase in soil pH but not with cation exchange capacity (CEC) or organic carbon (OC) content. No significant correlation was found between the toxicity of zinc nitrate to earthworms or plants and soil pH, CEC, or OC content. Possible consequences of the results are discussed, such as the testing of natural soils in addition to the OECD artificial soil or the inclusion of an additional safety factor to use the EC50 in current risk assessment schemes focusing on no‐observed‐effect concentrations.

According to the German Federal Soil Protection Act (BBodSchG 1998), the habitat function of soils must be protected. Despite the fact that in the Federal Soil Protection Ordinance (BBodSchV 1999) it has not been established how this goal can be reached reliably, it is clear that such a biological function can only adequately be assessed using biological test methods. This is especially true when a soil is contaminated by a mixture of often unknown chemicals. In such a case the use of chemical analysis aiming at a small range of known substances is not sufficient and must therefore be supplemented by biological methods. For this reason, several standardised test methods are available (e.g. using earthworms, collembolans or plants; Roembke and Knacker 2003; ISO 2003). Since acute tests are usually not sensitive enough for the assessment of potentially contaminated soils, chronic tests like the earthworm reproduction tests (ISO 1998) are recommended for this purpose. A chronic plant test for the determination of phytotoxicity was missing until quite recently. The term phytotoxicity is understood here as the capacity of a compound or a contaminated soil to cause temporary or long-lasting damage to plants (EPPO 1997). Therefore, the German Ministry for Education and Research sponsored a project (1997-1999) in which - based on existing standardised methods - such a chronic plant laboratory test was developed and partly validated. The new test can be used for the evaluation of single chemicals as well as for the assessment of contaminated or remediated soils. As part of the efforts to improve the biological testing of contaminated soils, the German government sponsored the standardisation of a chronic plant bioassay. This new test is based on experiences with various acute plant tests (e.g. published by OECD or ISO) and existing North American Plant-Life-Cycle Bioassays. In this contribution the characteristic properties of the test are described. The test can be performed either with Brassica rapa (turnip) or Avena sativa (oat). Its duration is 35 to 64 days with OECD artificial soil and a German standard field soil acting as controls. Water and nutrients are provided by an automatic wick irrigation system. Besides measuring biomass and shoot length, the number of pods, seeds and flowers are applied as chronic measurement endpoints. During the development of the test, TNT (2,4,6-trinitrotoluene) and Pyrene were used as model test substances. Pyrene did not affect B. rapa (turnip) in concentrations of up to 10.000 mg/kg soil (due to the often low sensitivity of A. sativa (oat) no further test with this substance was performed). Depending on the endpoint the results varied in the tests with TNT. With few exceptions, the NOEC (No Observed Effect Concentration) values were determined as 55.5 mg TNT/kg soil for B. rapa (turnip) and as 75 (unfertilised) and 150 (fertilised) mg TNT/kg soil for A. sativa (oat). The EC50-values varied between 96.3 and 207.2 mg TNT/kg soil for B. rapa (turnip) and 183.1-505.6 mg TNT/kg soil for A. sativa (oat), depending on the endpoint. The results of this work have been used to prepare a draft test guideline, which has recently been standardised by the International Organisation for Standardisation (ISO). Practical experiences with this test system are described in Part II of this mini series.

Junker discusses how Stephen Jay Gould tries to demonstrate the connection between anthropology and racism in the case of Johann Friedrich Blumenbach.

The Synthetic Theory of Evolution (SyntheticDarwinism) was forged between 1925 and 1950.Several historians of science have pointed outthat this synthesis was a joint venture ofSoviet, German, American and Britishbiologists: A fascinating example of scientificcooperation, considering the fact that theevolutionary synthesis emerged during thedecades in which these countries were engagedin fierce political, military and ideologicalconflicts. The ideological background of itsAnglo-American representatives has beenanalyzed in the literature. We have examinedthe scientific work and ideological commitmentsof the German Darwinians during the ThirdReich. We based our analysis on four criteria:1) General attitude towards the Third Reich. 2) Membership in the NSDAP and other nationalsocialist organizations. Endorsement anddisapproval of the state ideology in 3) scientific and 4) other publications. We willmainly discuss the various authors that havecontributed to Die Evolution derOrganismen (1943), a collection thatrepresented the evolutionary synthesis inGermany. Most of the authors promoted eugenicideas, but not all of them adopted the racistinterpretation of the Third Reich. Anotherfinding is that there existed no directconnection between party membership andpromotion of the state ideology.[PUBLICATION ABSTRACT]

SummaryA metatheoretical and historiographical re-analysis of the Evolutionary Synthesis (the process) and the Synthetic Theory (the result) leads to the following conclusion: The Synthetic Theory is not a reductionistic, but rather a structuralistic theory with a limited range of relevant hierarchical levels. Historically the Synthesis was not a sudden event but a rational long-term project carried out between 1930 and 1950 by a large number of biologists in several countries. In the second part of our paper the contributions of several German biologists to the Synthesis are analyzed.