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[This corrects the article DOI: 10.1016/j.lanepe.2022.100393.].
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Background: Multisystem inflammatory syndrome in children (MIS-C) is the most severe clinical entity associated with pediatric SARS-CoV-2 infection with a putative role of the spike protein into the immune system activation. Whether COVID-19 mRNA vaccine can induce this complication in children is unknown. We aimed to assess the risk of hyper-inflammatory syndrome following COVID-19 mRNA vaccine in children. Methods: We conducted a post-authorization national population-based surveillance using the French enhanced pharmacovigilance surveillance system for COVID-19 vaccines. All cases of suspected hyper-inflammatory syndrome following COVID-19 mRNA vaccine in 12-17-year-old children between June 15th, 2021 and January 1st, 2022, were reported. Cases were reviewed according to WHO criteria for MIS-C. The reporting rate of this syndrome was compared to the MIS-C rate per 1,000,000 12-17-year-old children infected by SARS-CoV-2. Findings: Up to January 2022, 8,113,058 COVID-19 mRNA vaccine doses were administered to 4,079,234 12-17-year-old children. Among them, 12 presented a hyper-inflammatory syndrome with multisystemic involvement. Main clinical features included male predominance (10/12, 83%), cardiac involvement (10/12, 83%), digestive symptoms (10/12, 83%), coagulopathy (7/12, 58%), cytolytic hepatitis (6/12, 50%), and shock (5/12, 42%). 4/12 (33%) required intensive care unit transfer, and 3/12 (25%) hemodynamic support. All cases recovered. In eight cases, no evidence of previous SARS-CoV-2 infection was found. The reporting rate was 1.5 (95%CI [0.8; 2.6]) per 1,000,000 doses injected, i.e. 2.9 (95%CI [1.5; 5.1]) per 1,000,000 12-17-year-old vaccinated children. As a comparison, 113 MIS-C (95%CI [95; 135]) occurred per 1,000,000 12-17-year-old children infected by SARS-CoV-2. Interpretation: Very few cases of hyper-inflammatory syndrome with multi-organ involvement occurred following COVID-19 mRNA vaccine in 12-17-year-old children. The low reporting rate of this syndrome, compared to the rate of post-SARS-CoV-2 MIS-C in the same age-group, largely supports the vaccination in a context of an important circulation of SARS-CoV-2. Funding: ESPID Fellowship Award; Grandir-Fonds de Solidarité Pour L'enfance.
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BACKGROUND: Neonates are considered as immunologically immature. There are no specific guidelines for surgical antibiotic prophylaxis in this population since data concerning the risk factors for surgical site infection (SSI) are lacking. METHODS: A 40-month retrospective single-center study that included all consecutive neonates undergoing surgery was performed. The variables that could influence the rate of SSI were analyzed by multivariate analysis in order to determine the independent risk factors for SSI. RESULTS: The survey included 286 neonates (91 F/195 M). Median age, term, and weight were 10 (0-19) days, 38 (37-39) weeks, 3 (2.7-3.5) kg, respectively. Sixteen percent of the neonates were premature. Surgery was mostly abdominal (71%). Prophylactic antibiotic was given in 66.4% of the cases and was highly variable (amoxicillin-clavulanate 20.3%, first generation cephalosporin 26.2%, second generation cephalosporin 11.9%, imidazole derivatives 13.6%, aminoglycosides 12.6%, vancomycin 0.7%, and ticarcillin-clavulanate 3.1%). The rate of SSI was 3.8%. Only two variables were identified as independent risk factors for SSI: gestational age OR: 0.821 (0.690-0.977) and preoperative hospitalization in an intensive care unit OR: 8.433 (1.031-69.005). CONCLUSION: Preoperative stay in an intensive care unit and, to a lesser degree, low gestational age are associated with an increased SSI rate.