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Background This study applies an umbrella review approach to summarise the global evidence on the risk of severe COVID-19 outcomes in patients with pre-existing health conditions. Methods Systematic reviews (SRs) were identified in PubMed, Embase/Medline and seven pre-print servers until December 11, 2020. Due to the absence of age-adjusted risk effects stratified by geographical regions, a re-analysis of the evidence was conducted. Primary studies were extracted from SRs and evaluated for inclusion in the re-analysis. Studies were included if they reported risk estimates (odds ratio (OR), hazard ratio (HR), relative risk (RR)) for hospitalisation, intensive care unit admission, intubation or death. Estimated associations were extracted from the primary studies for reported pre-existing conditions. Meta-analyses were performed stratified for each outcome by regions of the World Health Organization. The evidence certainty was assessed using GRADE. Registration number CRD42020215846. Results In total, 160 primary studies from 120 SRs contributed 464 estimates for 42 pre-existing conditions. Most studies were conducted in North America, European, and Western Pacific regions. Evidence from Africa, South/Latin America, and the Eastern Mediterranean region was scarce. No evidence was available from the South-East Asia region. Diabetes (HR range 1.2–2.0 (CI range 1.1–2.8)), obesity (OR range 1.5–1.75 (CI range 1.1–2.3)), heart failure (HR range 1.3–3.3 (CI range 0.9–8.2)), COPD (HR range 1.12–2.2 (CI range 1.1–3.2)) and dementia (HR range 1.4–7.7 (CI range 1.2–39.6)) were associated with fatal COVID-19 in different regions, although the estimates varied. Evidence from Europe and North America showed that liver cirrhosis (OR range 3.2–5.9 (CI range 0.9–27.7)) and active cancer (OR range 1.6–4.7 (CI range 0.5–14.9)) were also associated with increased risk of death. Association between HIV and undesirable COVID-19 outcomes showed regional heterogeneity, with an increased risk of death in Africa (HR 1.7 (CI 1.3–2.2)). GRADE certainty was moderate to high for most associations. Conclusion Risk of undesirable COVID-19 health outcomes is consistently increased in certain patient subgroups across geographical regions, showing high variability in others. The results can be used to inform COVID-19 vaccine prioritisation or other intervention strategies.

Purpose: To investigate the risk of Pediatric Inflammatory Multisystem Syndrome temporally associated with SARS-CoV-2 (PIMS-TS) in children depending on periods with different dominant variants of concern (VOC) of SARS-CoV-2.Methods: The risk of developing PIMS-TS in three phases of the pandemic with different VOC (Alpha, Delta, and Omicron) was calculated using data of rtPCR confirmed SARS-CoV-2 infections extracted from the German statutory notification system and reports of cases with PIMS-TS captured by a national, prospective registry. Overall and age group-specific rate ratios of PIMS-TS rates in the different observation periods, using the Alpha period as the baseline, were calculated.Results: The rate of PIMS-TS changed significantly over time. During April-August 2021, with dominant VOC Alpha_B.1.1.7, the PIMS-TS rate was 6.19 (95% confidence intervals (95% CI) 5.17, 7.20), decreased to 1.68 (95% CI 1.49, 1.87) in August 2021 to January 2022 with Delta_AY and to 0.89 (95% CI 0.79, 1.00) in January-April 2022 with Omicron_BA as dominant VOC. This corresponds to a decrease in PIMS-TS rate of 73% (rate ratio 0.271, 95% CI 0.222; 0.332) and 86% (rate ratio 0.048, 95% CI 0.037; 0.062), respectively, compared to the Alpha period. Rate ratios were almost identical for all age groups.Conclusion: The data strongly suggest a relation of the risk for PIMS-TS to the prevailing VOC with the highest risk related to Alpha_B.1.1.7 and the lowest with Omicron_BA. Uniformity of the decrease across age groups does not suggest a major role for vaccination on the risk of PIMS-TS in infected children.

Vaccines against COVID-19 have been available in Germany since December 2020. At the Robert Koch Institute (RKI), the Immunization Unit is responsible for monitoring vaccination coverage and assessment of vaccine effectiveness. This article provides an overview of the respective reporting structures, vaccination databases, and epidemiological studies established by the Immunization Unit during the COVID-19 pandemic. We describe the COVID-19 Digital Vaccination Coverage Monitoring (DIM), which provides daily updates on vaccination coverage by age group. We next describe how, based on the DIM data and COVID-19 case data, the assessment of vaccine effectiveness against different clinical endpoints (hospitalization, intensive care, death) is performed. While this method is used for a preliminary estimate of vaccine efficacy, population-based nonrandomized studies are able to provide more precise and detailed estimates under "real-world" conditions. In this context, we describe the hospital-based case-control study COViK, which is being conducted in collaboration with the Paul Ehrlich Institute (PEI). We discuss strengths and limitations of the abovementioned structures and tools. Finally, we provide an outlook on future challenges that may arise during the ongoing pandemic and during the transition phase into an endemic situation.Seit Dezember 2020 stehen in Deutschland Impfstoffe gegen COVID-19 zur Verfügung. Zu den Hauptaufgaben des Fachgebiets Impfprävention des Robert Koch-Instituts (RKI) in der COVID-19-Pandemie gehören die Erhebung von Impfquoten und das Monitoring der Wirksamkeit der Impfung. Der Artikel gibt einen Überblick über die hierfür während der Pandemie etablierten Strukturen, Datengrundlagen und Studien. Ausgehend vom Digitalen Impfquotenmonitoring (DIM), welches für die tagesaktuelle Berechnung der Impfquote in mehreren Altersgruppen verwendet wird, werden die Berechnung der Inzidenzen nach Impfstatus und die Methodik der Impfeffektivitätsschätzung gegen verschiedene Endpunkte (Hospitalisierung, intensivstationäre Betreuung, Tod) beschrieben. Während diese Methode lediglich eine erste Abschätzung der Impfeffektivität erlaubt, kann in bevölkerungsbezogenen nichtrandomisierten Studien eine detailliertere und genauere Untersuchung der Wirksamkeit der COVID-19-Impfstoffe unter Realbedingungen erfolgen. Hierzu wird die gemeinsam mit dem Paul-Ehrlich-Institut (PEI) durchgeführte krankenhausbasierte Fall-Kontrollstudie COViK vorgestellt. Die Vorteile und Limitationen der genannten Strukturen und Instrumente werden diskutiert. Abschließend wird ein Ausblick auf hieraus resultierende künftige Herausforderungen in der Pandemie und beim Übergang in die endemische Lage gegeben.

Background Several vaccine and antibody candidates are currently in development for the prevention of lower respiratory tract infections caused by the respiratory syncytial virus (RSV). Methods We searched MEDLINE, Embase, and SCOPUS and included model-based evaluations of RSV vaccinations. Two reviewers performed the selection, data extraction, and quality evaluation with EVIDEM. Cost-effectiveness (CE) estimates were converted to $US purchasing power parity (PPP), year 2018 values. Potential economic and epidemiological outcomes were summarised for maternal, infant, children, and elderly vaccinations. The PROSPERO identifier is CRD42019122570. Results In total, 22 model-based studies were reviewed. On average, a potential 27% reduction in RSV hospitalisations in infants was projected for maternal vaccination and 50% for direct infant immunisation. The CE of maternal vaccination was $US1766–5857 PPP 2018/disability-adjusted life-years (DALYs) for Global Alliance for Vaccines and Immunisation (Gavi)-eligible countries. For England, the maximum cost-effective price of maternal vaccination was estimated at $US81.5 PPP 2018. Infant vaccination was associated with higher CE ratios in low- and high-income settings. Vaccination of neonates born before the RSV season was the most cost effective in high-income settings. Higher values for vaccine effectiveness, duration of protection, and vaccine uptake increased the benefits. Due to indirect effects, the vaccination of school-age children and a cocooning strategy were effective alternatives to protect infants, and the vaccination of children aged < 5 years had a beneficial impact on the elderly. Conclusion RSV vaccines with anticipated characteristics may reduce a sizeable proportion of the RSV burden. The results are subject to uncertainty because of the limited epidemiological and clinical data. Data on RSV incidence and hospitalisation risk for granular age strata should be prioritised to facilitate the evaluation of RSV interventions and decision making. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-020-00991-7.

Background: This umbrella review summarises the global evidence on the risk of severe COVID-19 outcomes in patients with pre-existing health conditions. Methods: Systematic reviews (SRs) were identified in PubMed, Embase/Medline, and seven pre-print servers until December 11, 2020. Risk estimates (odds ratio (OR), hazard ratio (HR), relative risk (RR)) for hospitalisation, intensive care unit admission, intubation, and death were extracted from primary studies. Meta-analyses were performed stratified by regions of the World Health Organisation. The evidence certainty was assessed using GRADE. Registration number CRD42020215846. Findings: 160 primary studies from 120 SRs contributed 464 estimates for 42 pre-existing conditions. Most studies were conducted in North America, European, and Western Pacific regions. Evidence from Africa, South/Latin America, and Eastern Mediterranean region was scarce. No evidence was available from South-East Asia region. Diabetes (HR 1∙2-2∙0 (1∙1-2∙8)), obesity (OR 1∙5-1∙75 (1∙1-2∙3)), heart failure (HR 1∙3-3∙3(0∙9-8∙2)), COPD (HR 1∙12-2∙2 (1∙1-3∙2)), and dementia (HR 1∙4-7.7 (1∙2-39∙6)) were associated with fatal COVID-19 in different regions, although the estimates varied. Evidence from Europe and North America showed that liver cirrhosis (OR 3∙2-5∙9 (0∙9-27∙7)) and active cancer (OR 1∙6-4∙7 (0∙5-14∙9)) were also associated with increased risk of death. Association between HIV and severe COVID-19 showed regional heterogeneity, with an increased risk of death in Africa (HR 1∙7 (1∙3-2∙2)). GRADE certainty was moderate to high for most associations. Interpretation: Risk of severe COVID-19 is consistently increased in certain patient subgroups across geographical regions, showing high variability in others. The results can be used to inform COVID-19 vaccine prioritisation or other intervention strategies. Funding Statement: Project ImVaCov – German Federal Ministry of Health Declaration of Interests: Authors declare no conflicts of interest.

BackgroundHaemophilus influenzae (Hi) serotype b (Hib) vaccination was introduced in Germany in 1990. This study presents a comprehensive overview on the burden of invasive Hi infections for 2001–2016, including serotype distribution and ampicillin resistance.MethodsNationwide data from statutory disease surveillance (2001–2016) were linked with laboratory surveillance data (2009–2016). Besides descriptive epidemiology, statistical analyses included multiple imputation to estimate secular trends.ResultsIn 2001–2016, 4044 invasive Hi infections were reported. The mean incidence was 3.0 per million inhabitants, higher in males (3.2 vs 2.9 in females) and in the age groups ConclusionsThis is one of the most comprehensive Hi data analyses since the introduction of Hib vaccines. NTHi and Hif cause an increasing disease burden among elderly patients and infants. Ampicillin resistance in NTHi must be considered in the treatment of invasive Hi infections.