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EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-336968


Background: The safety of SARS-CoV-2 vaccines is unknown in children aged <5 years. Here, we retrospectively evaluated the safety of BNT162b2 vaccine used off-label in children of this age group in Germany. Methods An investigator-initiated retrospective cohort study (CoVacU5) included parents or caregivers having children aged <5 years registered for SARS-CoV-2 vaccination in outpatient care facilities in Germany. Reported short-term safety data of 1-3 doses of 3-10ug BNT162b2 in children aged 0 to <60 months are presented. Co-primary outcomes were the frequencies of 11 categories of symptoms post-vaccination with bivariate analyses and regression models adjusting for age, sex, weight and height. On-label non-SARS-CoV-2 vaccines served as controls in an active-comparator design. Results The study included 7806 representing a 41% response rate of 19,000 registered children. 338 children received the first dose of BNT162b2 at age 0-<12 months, n=1272 at age 12-24 months and n=5629 at age ≥24 to <60 months. A 10ug dosage was more frequently associated with injection-site symptoms compared to lower dosages. The probability of any symptoms (OR: 1.62 [95% confidence interval (CI): 1.36-1.94]), injection-site, musculoskeletal, dermatological or otolaryngological symptom categories were modestly elevated after BNT12b2 compared to non-SARS-CoV-2 vaccines, whereas the probabilities of general symptoms (OR: 0.74 [95% CI: 0.64-0.85]) and fever (OR: 0.43 [95% CI: 0.35-0.51]) were lower after BNT162b2. Symptoms requiring hospitalization (n=10) were reported only at BNT162b2 dosages higher than 3ug. Conclusions The symptoms reported after BNT162b2 administration were overall comparable to on-label non-SARS-CoV-2 vaccines in this cohort of children aged <5 years.

Z Evid Fortbild Qual Gesundhwes ; 165: 35-42, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1392650


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.

COVID-19 , SARS-CoV-2 , Aged , Aged, 80 and over , Cross-Sectional Studies , Germany , Humans , Male , Physicians, Family
Ir J Med Sci ; 191(1): 31-37, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1086658


KEY POINTS: In our clinical cross-sectional study, we identified 107 of 347 patients who were tested positive for antibodies of novel Coronavirus 2019 (SARS-CoV-2). Main symptoms were exhaustion and cough, exposition to other COVID-19-patients appeared frequently. BACKGROUND: There is urgent need for information on predictive parameters on immunity and infectivity in Coronavirus disease-2019 (COVID-19) pandemic. Our aim was to investigate distribution of novel Coronavirus 2019 (SARS-CoV-2) infections in a German General Practice and to learn about possible predictive parameters regarding infection and pathways of transmission. METHODS: In our cross-sectional study, we tested 347 patients of our General Practice using 2019-nCoV-2-IgG/IgM antibody test [2019-nCoV2 IgG/IgM Rapid Test Cassette (Ref.: INCP-402/INCP-402B; ACRO, BIOTECH, INC.)]. We asked for 13 specific symptoms and 4 questions to investigate patients' surroundings. RESULTS: A total of 107 of 347 patients were tested positive for antibodies (Immunoglobulin M-positive and/or Immunoglobulin G-positive). In antibody-positive group, body aches and rhinorrhea were seen more often and there were significantly less asymptomatic patients. Stay in area of risk was significantly more frequent in antibody-positive group as well as contact to infected persons. Distribution of other symptoms was not significantly different between both groups. Most adults or children with SARS-CoV-2 infection presented with mild flu-like symptoms. CONCLUSION: A total of 30% of patients had antibodies. It was not possible to identify one solid predictive symptom. Serological testing may be helpful for the diagnosis of suspected patients with negative RT-PCR results and for the identification of asymptomatic infections.

COVID-19 , SARS-CoV-2 , Adult , Antibodies, Viral , Child , Cross-Sectional Studies , Family Practice , Humans , Pandemics , Sensitivity and Specificity