First EFSA experiences with monitoring plans

A plan for Post Market Environmental Monitoring (PMEM) of genetically modified (GM) plants is mandatory in all applications for deliberate release submitted under EU Directive 2001/18/EC and EU Regulation 1829/2003. PMEM is composed of case-specific monitoring and general surveillance of GM plants. The European Food Safety Authority (EFSA) is responsible for assessing the scientific quality of PMEM plans submitted with each application. In a scientific opinion, the EFSA GMO Panel presented specific guidance for applicants for developing PMEM plans. In addition the EFSA GMO Panel explained the scientific rationale for this guidance and makes a number of recommendations for the management and conduct of PMEM by both applicants and risk managers. Until the end of March 2007, the EFSA GMO Panel gave opinions on 11 PMEM plans submitted under EU Directive 2001/18/EC and another 11 plans submitted within applications under EU Regulation 1829/2003. Currently 27 applications for GM plants are still in the evaluation process and the EFSA GMO Panel sent 26 questions to the applicants for clarification and additional information during the evaluation process. Sixteen of these questions were related to General Surveillance (e.g. general structure, farm & operator questionnaires, integrations of identity preservation systems, use of existing surveillance systems, feral plant surveillance). Nine questions requested clarification on the environmental risk assessment, which might effect whether case-specific monitoring is needed. In one case (an application for cultivation of a GM crop), the GMO Panel recommended case-specific monitoring. We explain in more detail how the environmental risk assessment of two Bt maize dossiers (maize Bt11 and 1507) were considered by the GMO Panel in the evaluation of the PMEM plan and the consequences for the environmental monitoring plan. As stated in the EFSA opinion on post-market environmental monitoring, the general surveillance plans shall, when possible, make use of existing monitoring systems in addition to more focused monitoring systems. However, the use of these national monitoring programmes is outside of the management and control of an individual applicant and thus it cannot be the task of an applicant alone to use, modify or improve existing surveillance systems. The availability of biodiversity monitoring programmes in the EU Member States should be evaluated by applicants in close liaison with risk manager

Mapping the human genetic architecture of COVID-19

The genetic make-up of an individual contributes to the susceptibility and response to viral infection. Although environmental, clinical and social factors have a role in the chance of exposure to SARS-CoV-2 and the severity of COVID-191,2, host genetics may also be important. Identifying host-specific genetic factors may reveal biological mechanisms of therapeutic relevance and clarify causal relationships of modifiable environmental risk factors for SARS-CoV-2 infection and outcomes. We formed a global network of researchers to investigate the role of human genetics in SARS-CoV-2 infection and COVID-19 severity. Here we describe the results of three genome-wide association meta-analyses that consist of up to 49,562 patients with COVID-19 from 46 studies across 19 countries. We report 13 genome-wide significant loci that are associated with SARS-CoV-2 infection or severe manifestations of COVID-19. Several of these loci correspond to previously documented associations to lung or autoimmune and inflammatory diseases3–7. They also represent potentially actionable mechanisms in response to infection. Mendelian randomization analyses support a causal role for smoking and body-mass index for severe COVID-19 although not for type II diabetes. The identification of novel host genetic factors associated with COVID-19 was made possible by the community of human genetics researchers coming together to prioritize the sharing of data, results, resources and analytical frameworks. This working model of international collaboration underscores what is possible for future genetic discoveries in emerging pandemics, or indeed for any complex human disease

Mapping the human genetic architecture of COVID-19

The genetic make-up of an individual contributes to the susceptibility and response to viral infection. Although environmental, clinical and social factors have a role in the chance of exposure to SARS-CoV-2 and the severity of COVID-191,2, host genetics may also be important. Identifying host-specific genetic factors may reveal biological mechanisms of therapeutic relevance and clarify causal relationships of modifiable environmental risk factors for SARS-CoV-2 infection and outcomes. We formed a global network of researchers to investigate the role of human genetics in SARS-CoV-2 infection and COVID-19 severity. Here we describe the results of three genome-wide association meta-analyses that consist of up to 49,562 patients with COVID-19 from 46 studies across 19 countries. We report 13 genome-wide significant loci that are associated with SARS-CoV-2 infection or severe manifestations of COVID-19. Several of these loci correspond to previously documented associations to lung or autoimmune and inflammatory diseases3,4,5,6,7. They also represent potentially actionable mechanisms in response to infection. Mendelian randomization analyses support a causal role for smoking and body-mass index for severe COVID-19 although not for type II diabetes. The identification of novel host genetic factors associated with COVID-19 was made possible by the community of human genetics researchers coming together to prioritize the sharing of data, results, resources and analytical frameworks. This working model of international collaboration underscores what is possible for future genetic discoveries in emerging pandemics, or indeed for any complex human disease