FRANCOIS ANGOULVANT (France)
Hopital universitaire Robert Debré Pediatric infectious diseases and internal medicineAuthor Of 4 Presentations
HYPER INFLAMMATORY SYNDROME FOLLOWING COVID-19 MRNA VACCINE IN CHILDREN: A NATIONAL POST-AUTHORIZATION PHARMACOVIGILANCE STUDY
Abstract
Backgrounds:
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. 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.
Results:
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.
Conclusions/Learning Points:
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.
PICU ADMISSION RELATED TO SARS-COV-2 BY VACCINATION STATUS.
Abstract
Backgrounds:
COVID-19 mRNA vaccine immunogenicity and effectiveness is well established in children and adolescents. Summer and autumn 2021 in France were marked by both, waves of COVID-19 cases due to the Delta variant, and by the recommendation of the French Public Health Agency (FPHA) to vaccinate children from the age of 12 years. The aim of this national study was to estimate PICU admission related to SARS-CoV2 by vaccination status - PICURE Study
Methods
From September 1, 2021 to January 5, 2022, all pediatric patients diagnosed with MIS-C according to WHO criteria and/or a positive SARS-CoV2 PCR and admitted to the 41 French Pediatric Intensive Care Units (PICU) were prospectively included in this study. Data regarding age, gender, admission to PICU, vaccination status of patients between 12 and 18 years, hereafter referred to as adolescents, were recorded. To account for the increasing numbers of adolescents vaccinated over time including during the period, hazard ratio (HR) of unvaccinated versus vaccinated adolescents was estimated using Cox proportional hazards model.
Results:
Among the 233 admitted children, 94 (40%) were females. Median age was 77 months (IQR: 7 to 138 months). Admission was related to 71(31%) acute SARS CoV-2 infection, to 109(47%) MIS-C, and 52 (22%) incidental diagnosis of SARS-CoV-2. At least one comorbidity was identified in 73 (31%) cases. Among the 55 included adolescents, 43 were not vaccinated, 5 were vaccinated against COVID-19 and the information was missing for 7 patients. The HR for PICU admission related to SARS-CoV2 was 0.04 (95% CI 0.02 to 0.10, p<.001) after COVID-19 mRNA vaccine compared with unvaccinated adolescents.
Conclusions/Learning Points:
The data suggest that COVID-19 mRNA vaccine in adolescents was associated with a decrease of PICU admission related to SARS-CoV2.
SARS-COV-2 INFECTION IN CHILDREN YOUNGER THAN 5 YEARS ACCORDING TO PARENT’S VACCINATION STATUS
Abstract
Backgrounds:
COVID-19 mRNA vaccine immunogenicity and effectiveness are well established in adolescents and children over 5 years of age. To date, COVID-19 mRNA vaccines are not licensed for younger children. The aim of this study was to estimate incidence of SARS-CoV-2 infection in children younger than 5 by parents COVID-19 vaccination status from the start of the general vaccination for all adults.
Methods
In this French national prospective surveillance, 66 pediatric departments enrolled children hospitalized with SARS-CoV-2 infection and/or or Multisystem Inflammatory Syndrome in Children (MIS-C). All children younger than 5 years admitted from 12/05/21 to 21/12/2021 with available data regarding parent’s vaccination status were included. To account for the increasing numbers of vaccinated parents over time including during the period in which cases were measured, hazard ratio (HR) of unvaccinated versus vaccinated parents was estimated using Cox proportional hazards model.
Results:
From 12/05/2021 to 21/12/2021, the number of French adults, 18 to 59 years, fully vaccinated rose from 7% to 90%. Among the 214 enrolled children, 164 (77%) were younger than 5 years, and parent’s vaccination was available for 81 (38%). Overall, 61 children with available parent’s vaccination status were included with 33 (65%) younger than 3 months, 7 (14%) aged from 3 to <12 months, and 11 (22%) aged from 12 to <60 months. Among them, 10 had at least one parent vaccinated, and 51 had none of their parents vaccinated. The HR for COVID-19 infection in children younger than 5 years was 0.03 (95% CI 0.02 to 0.07, p<.001) with vaccinated parents compared with unvaccinated.
Conclusions/Learning Points:
Parent’s COVID-19 vaccination was associated with a dramatic decrease risk of admission related to COVID-19 infection in children younger than 5.
UNRAVELLING THE FUNDAMENTAL LINK BETWEEN PNEUMOCOCCAL CARRIAGE, RESPIRATORY VIRAL INFECTION, AND PEDIATRIC INVASIVE PNEUMOCOCCAL DISEASES: A TIME SERIES ANALYSIS BASED ON MULTIPLE NATIONAL SURVEILLANCE SYSTEMS
Abstract
Backgrounds:
An unbreakable relationship has been established between pneumococcal carriage and invasive pneumococcal disease (IPD), with IPD supposed to be the direct consequence of carriage dynamics. We aimed to assess the role of pneumococcal carriage dynamics and the viral epidemiology in the unprecedented IPD epidemiology related to non-pharmaceutical interventions (NPIs) implemented during the COVID-19 pandemic.
Methods
We performed a quasi-experimental interrupted time series analysis based on multiple national surveillance systems of pneumococcal carriage, respiratory syncytial virus (RSV) and influenza-related diseases, and IPD in children <15 years old in France. We estimated the fraction of IPD change after NPIs that was attributable to RSV, influenza and pneumococcal carriage dynamics, analyzed by a quasi-Poisson regression model.
Results:
Between November 2006 and April 2021, 5113 IPD cases were included and 6831 healthy children had a swab test. After NPI implementation, the IPD incidence decreased 63% (95%CI, -82% to -43%, P<.001, Figure) while the overall pneumococcal carriage rate did not significantly change (-12%, 95%CI, -37% to 12%, P=.32). We estimated that 53% (95%CI, 28% to 78%, P<.001) and 40% (95%CI, 15% to 65%, P=.002) of the decrease in IPD in the NPI period was attributable to the change in influenza and RSV epidemiology, respectively. Only 4% (95%CI, -7% to 15%, P=.49) was attributable to a change in pneumococcal carriage. We found similar results when analyzing only high and low-disease potential serotypes.
Conclusions/Learning Points:
The major decrease in pediatric IPD incidence after NPIs was related to a change in viral dynamics rather than pneumococcal carriage. The fundamental link between pneumococcal carriage and IPD is highly affected by viral epidemiology. Interventions targeting respiratory viruses, such as immunoprophylaxis or vaccines against RSV and influenza, may prevent a large part of pediatric IPD.
Presenter of 3 Presentations
HYPER INFLAMMATORY SYNDROME FOLLOWING COVID-19 MRNA VACCINE IN CHILDREN: A NATIONAL POST-AUTHORIZATION PHARMACOVIGILANCE STUDY
Abstract
Backgrounds:
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. 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.
Results:
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.
Conclusions/Learning Points:
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.
PICU ADMISSION RELATED TO SARS-COV-2 BY VACCINATION STATUS.
Abstract
Backgrounds:
COVID-19 mRNA vaccine immunogenicity and effectiveness is well established in children and adolescents. Summer and autumn 2021 in France were marked by both, waves of COVID-19 cases due to the Delta variant, and by the recommendation of the French Public Health Agency (FPHA) to vaccinate children from the age of 12 years. The aim of this national study was to estimate PICU admission related to SARS-CoV2 by vaccination status - PICURE Study
Methods
From September 1, 2021 to January 5, 2022, all pediatric patients diagnosed with MIS-C according to WHO criteria and/or a positive SARS-CoV2 PCR and admitted to the 41 French Pediatric Intensive Care Units (PICU) were prospectively included in this study. Data regarding age, gender, admission to PICU, vaccination status of patients between 12 and 18 years, hereafter referred to as adolescents, were recorded. To account for the increasing numbers of adolescents vaccinated over time including during the period, hazard ratio (HR) of unvaccinated versus vaccinated adolescents was estimated using Cox proportional hazards model.
Results:
Among the 233 admitted children, 94 (40%) were females. Median age was 77 months (IQR: 7 to 138 months). Admission was related to 71(31%) acute SARS CoV-2 infection, to 109(47%) MIS-C, and 52 (22%) incidental diagnosis of SARS-CoV-2. At least one comorbidity was identified in 73 (31%) cases. Among the 55 included adolescents, 43 were not vaccinated, 5 were vaccinated against COVID-19 and the information was missing for 7 patients. The HR for PICU admission related to SARS-CoV2 was 0.04 (95% CI 0.02 to 0.10, p<.001) after COVID-19 mRNA vaccine compared with unvaccinated adolescents.
Conclusions/Learning Points:
The data suggest that COVID-19 mRNA vaccine in adolescents was associated with a decrease of PICU admission related to SARS-CoV2.
SARS-COV-2 INFECTION IN CHILDREN YOUNGER THAN 5 YEARS ACCORDING TO PARENT’S VACCINATION STATUS
Abstract
Backgrounds:
COVID-19 mRNA vaccine immunogenicity and effectiveness are well established in adolescents and children over 5 years of age. To date, COVID-19 mRNA vaccines are not licensed for younger children. The aim of this study was to estimate incidence of SARS-CoV-2 infection in children younger than 5 by parents COVID-19 vaccination status from the start of the general vaccination for all adults.
Methods
In this French national prospective surveillance, 66 pediatric departments enrolled children hospitalized with SARS-CoV-2 infection and/or or Multisystem Inflammatory Syndrome in Children (MIS-C). All children younger than 5 years admitted from 12/05/21 to 21/12/2021 with available data regarding parent’s vaccination status were included. To account for the increasing numbers of vaccinated parents over time including during the period in which cases were measured, hazard ratio (HR) of unvaccinated versus vaccinated parents was estimated using Cox proportional hazards model.
Results:
From 12/05/2021 to 21/12/2021, the number of French adults, 18 to 59 years, fully vaccinated rose from 7% to 90%. Among the 214 enrolled children, 164 (77%) were younger than 5 years, and parent’s vaccination was available for 81 (38%). Overall, 61 children with available parent’s vaccination status were included with 33 (65%) younger than 3 months, 7 (14%) aged from 3 to <12 months, and 11 (22%) aged from 12 to <60 months. Among them, 10 had at least one parent vaccinated, and 51 had none of their parents vaccinated. The HR for COVID-19 infection in children younger than 5 years was 0.03 (95% CI 0.02 to 0.07, p<.001) with vaccinated parents compared with unvaccinated.
Conclusions/Learning Points:
Parent’s COVID-19 vaccination was associated with a dramatic decrease risk of admission related to COVID-19 infection in children younger than 5.
Poster Author Of 1 e-Poster
EP394 - CLINICAL SPECTRUM OF SARS-COV-2 INFECTION ACCORDING TO VARIANT IN INFANTS YOUNGER THAN 3 MONTHS (ID 1276)
- Michaël Levy (France)
- Naim Ouldali (Canada)
- Pierre Mornand (France)
- Paul Casha (France)
- Fouad Madhi (France)
- Alexis Rybak (France)
- Robert Cohen (France)
- Vincent Gajdos (France)
- Camille Aupiais (France)
- Manon Passard (France)
- Noémie Vanel (France)
- Irina Craiu (France)
- Corinne Levy (France)
- FRANCOIS ANGOULVANT (France)