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Background: Sex differences exist not only in the efficacy but also in adverse event rates of many vaccines. Here we compared the safety of BNT162b2 vaccine administered off-label in female and male children younger than 5 years in Germany., Methods: This is a retrospective cohort study, in which we performed a post-hoc analysis of a dataset collected through an authentication-based survey of individuals having registered children aged 0-<5 years for vaccination against SARS-CoV-2 in six private practices and/or two lay person-initiated vaccination campaigns. We analyzed the safety profiles of the first 3 doses of 3-10 µg BNT162b2. Primary outcome was comparison in frequencies of 4 common post-vaccination symptom categories such as local, general, musculoskeletal symptoms and fever. Data were analyzed according to sex in bivariate analyses and regression models adjusting for age, weight, and dosage. Interaction between sex and BNT162b2 dosage was assessed. An active-comparator analysis was applied to compare post-vaccination symptoms after BNT162b2 versus non-SARS-CoV-2 vaccines., Results: The dataset for the present analysis consisted of 7801 participants including 3842 females (49%) and 3977 males (51%) with an age of 3 years (median, interquartile: 2 years). Among individuals receiving 3 µg BNT162b2, no sex differences were noted, but after a first dose of 5-10 µg BNT162b2, local injection-site symptoms were more prevalent in girls compared to boys. In logistic regression, female sex was associated with higher odds of local symptoms, odds ratio (OR) of 1.33 (95% confidence interval [CI]: 1.15-1.55, p < 0.05) and general symptoms with OR 1.21 (95% CI: 1.01-1.44, p < 0.05). Following non-BNT162b2 childhood vaccinations, female sex was associated with a lower odds of post-vaccination musculoskeletal symptoms (OR: 0.29, 95% CI: 0.11-0.82, p < 0.05). An active comparator analysis between BNT162b2 and non-SARS-CoV-2 vaccinations revealed that female sex positively influenced the association between BNT162b2 vaccine type and musculoskeletal symptoms., Conclusions: Sex differences exist in post-vaccination symptoms after BNT162b2 administration even in young children. These are of importance for the conception of approval studies, for post-vaccination monitoring and for future vaccination strategies (German Clinical Trials Register ID: DRKS00028759)., (© 2024. The Author(s).)

Background: Routinely collected health data from ambulatory care providers offer a wide range of research opportunities. However, the access is often (e.g., technically) hindered, particularly in Germany. In the following, we describe the development of an infrastructure for the analysis of pseudonymized routine data extracted from primary care practices in Germany. Further, we analyze the impact of the outbreak of SARS-CoV-2 on the utilization of primary care services for patients with type 2 diabetes mellitus (DM type 2)., Methods: In this retrospective cohort study, routine data were extracted from nine private primary care practices before and since the outbreak of SARS-CoV-2 in Germany. The sample consisted of patients who were treated between 2016 and 2022 in one of the participating practices. The effects of the outbreak on the frequency of practice visits and the disease course of DM type 2 patients were analyzed by means of bivariate and multivariate analyses., Results: The developed infrastructure offers an analysis of routine data from outpatient care within 24 h. In total, routine data of 30,734 patients could be processed for the analyses with 4182 (13.6%) patients having a diagnosed DM type 2 and 59.0% of these patients were enrolled in a disease management program (DMP). In the multivariate analysis, there was a significant negative effect of the SARS-CoV-2 outbreak on utilization of outpatient services of patients with DM type 2 disease. This decrease was less pronounced among DMP patients. The glycated haemoglobin level (HbA1c) has not changed significantly., Conclusions: The study showed that the analysis of routine data from outpatient care in Germany is possible in a timely manner using a special developed electronic health record system and corresponding software. The significantly negative effect of the SARS-CoV-2 outbreak on utilization of outpatient services of patients with DM type 2 disease was less pronounced among DMP patients. Two years after the start of the Covid pandemic a significantly worsened course of illness cannot be observed. However, it must be taken into account that the observation period for clinically relevant outcomes is still relatively short., (© 2022. The Author(s).)

Importance: SARS-CoV-2 vaccines are authorized for use in most age groups. The safety of SARS-CoV-2 vaccines is unknown in children younger than 5 years., Objective: To retrospectively evaluate the safety of the BNT162b2 vaccine used off-label in children younger than 5 years compared with the safety of non-SARS-CoV-2 vaccines in the same sample., Design, Setting, and Participants: This investigator-initiated retrospective cohort study included parents or caregivers who registered children for SARS-CoV-2 vaccination in outpatient care facilities in Germany. The study was performed as an authenticated online survey. A total of 19 000 email addresses were contacted from vaccination registration databases between April 14 and May 9, 2022. Inclusion criteria were child age younger than 5 years at the first BNT162b2 vaccination and use of a correct authentication code to prove invitation., Exposures: Off-label BNT162b2 vaccination and on-label non-SARS-CoV-2 vaccinations., Main Outcomes and Measures: Reported short-term safety data of 1 to 3 doses of 3 to 10 μg BNT162b2 in children from birth to younger than 60 months are presented. Coprimary outcomes were the frequencies of 11 categories of symptoms after vaccination with bivariate analyses and regression models adjusting for age, sex, weight, and height., Results: The study included 7806 children (median age, 3 years [IQR, 2-4 years]; 3824 [49.0%] female) who were followed up of for a mean (SD) of 91.4 (38.8) days since first BNT162b2 vaccination (survey response rate, 41.1%). A 10-μg dosage was more frequently associated with local injection-site symptoms compared with lower dosages. In the active-comparator analysis, the probability of any symptoms (odds ratio [OR], 1.62; 95% CI, 1.43-1.84), local symptoms (OR, 1.68; 95% CI, 1.38-2.05), musculoskeletal symptoms (OR, 2.55; 95% CI, 1.32-4.94), dermatologic symptoms (OR, 2.18; 95% CI, 10.7-4.45), or otolaryngologic symptoms (OR, 6.37; 95% CI, 1.50-27.09) were modestly elevated after BNT162b2 compared with non-SARS-CoV-2 vaccines, whereas the probabilities of general symptoms (OR, 0.77; 95% CI, 0.63-0.95) and fever (OR, 0.42; 95% CI, 0.32-0.55) were lower after BNT162b2. Symptoms requiring hospitalization (n = 10) were reported only at BNT162b2 dosages above 3 μg., Conclusions and Relevance: In this cohort study, the symptoms reported after BNT162b2 administration were comparable overall to those for on-label non-SARS-CoV-2 vaccines in this cohort of children younger than 5 years. The present data may be used together with prospective licensure studies of BNT162b2 efficacy and safety and could help guide expert recommendations about BNT162b2 vaccinations in this age group.

Background: In Germany, family physicians care for about 85% of the patients infected with SARS-CoV-2. The geographic distribution of the first wave in 2020 was heterogeneous, and each federal state experienced different percentages of patients that died from COVID-19. Each of the 16 federal states implemented its own regulation about medical care for SARS-CoV-2 infected patients. Against this background, the objective of this analysis was to gather experiences made by primary care physicians managing SARS-CoV-2 infected patients during the first wave in March 2020 and to clinically characterize these patients., Methods: In total, 5,632 physicians were invited to participate in an online questionnaire surveying routine data regarding the general care situation at the physician practice level and the care for patients infected with SARS-CoV-2. Bivariate and multivariate analyses were applied to characterize treatment experiences and to identify patient characteristics predicting the course of disease., Results: 132 family physicians from all German federal states (except from Berlin) participated in this analysis (response rate 2.3%) and provided routine care data for 1,085 patients. Information from 373 of these patients were provided in greater detail. On average, each physician treated 8.5 patients infected with SARS-CoV-2. About 15% of the physicians used video consultations to communicate with their infected patients. More than 82% made positive experiences with the exceptional regulation to provide a certificate of incapacity to work by telephone. Half of the physicians faced equipment insufficiencies due to a lack of protective gear, and in 10% of the practices, the staff themselves acquired SARS-CoV-2 infection. Greater numbers of SARS-CoV-2 cases treated in a practice translated into higher odds for members of the practice to get infected (odds ratio (OR) 1.03, 95% CI [1.01;1.06]). Older persons, males and patients in rural areas had higher odds of a severe course of disease., Conclusions: Our results show that a large percentage of primary care physicians additionally managed their COVID-19 patients remotely by telephone or video during the outbreak, while also being at a higher risk for SARS-CoV-2 infection. Further, the increased severity in rural areas underlines the importance of strong primary health care in order to enable hospitals to concentrate on critically ill patients., (Copyright © 2021. Published by Elsevier GmbH.)