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Hyper inflammatory syndrome following COVID-19 mRNA vaccine in children: A national post-authorization pharmacovigilance study.
Ouldali, Naïm; Bagheri, Haleh; Salvo, Francesco; Antona, Denise; Pariente, Antoine; Leblanc, Claire; Tebacher, Martine; Micallef, Joëlle; Levy, Corinne; Cohen, Robert; Javouhey, Etienne; Bader-Meunier, Brigitte; Ovaert, Caroline; Renolleau, Sylvain; Hentgen, Veronique; Kone-Paut, Isabelle; Deschamps, Nina; De Pontual, Loïc; Iriart, Xavier; Guen, Christelle Gras-Le; Angoulvant, François; Belot, Alexandre.
  • Ouldali N; Assistance Publique-Hôpitaux de Paris, Department of general paediatrics, paediatric infectious disease and internal medicine, Robert Debré university hospital, Université de Paris, Paris, France.
  • Bagheri H; Infectious Diseases Division, CHU Sainte Justine - Montreal University, Montreal, Quebec, Canada.
  • Salvo F; ACTIV, Association Clinique et Thérapeutique Infantile du Val-de-Marne, Créteil, France.
  • Antona D; Université de Paris, INSERM UMR 1123, ECEVE, Paris, France.
  • Pariente A; Department of Medical and Clinical Pharmacology, Regional Pharmacovigilance Center, CIC 1436, Toulouse University Hospital, France.
  • Leblanc C; INSERM, BPH, U1219, Team Pharmacoepidemiology, Université de Bordeaux, 33000 Bordeaux, France.
  • Tebacher M; Pole de Santé Publique, Service de Pharmacologie Médicale, Regional pharmacovigilance center of Bordeaux, CHU de Bordeaux, 33000 Bordeaux, France.
  • Micallef J; Santé Publique France, Agence nationale de Santé publique, Saint-Maurice, France.
  • Levy C; Team Pharmacoepidemiology, U1219 BPH Research Center, Bordeaux University, INSERM, Bordeaux, France.
  • Cohen R; Assistance Publique-Hôpitaux de Paris, Department of general paediatrics, paediatric infectious disease and internal medicine, Robert Debré university hospital, Université de Paris, Paris, France.
  • Javouhey E; Regional pharmacovigilance center of Strasbourg, HUS, Strasbourg, France.
  • Bader-Meunier B; Marseille University hospital, Clinical pharmacology department Regional Pharmacovigilance Center of Marseille, France.
  • Ovaert C; Aix-Marseille University, INSERM UMR 1106, Marseille, France.
  • Renolleau S; ACTIV, Association Clinique et Thérapeutique Infantile du Val-de-Marne, Créteil, France.
  • Hentgen V; Centre Hospitalier Intercommunal, Research Center, Université Paris Est, IMRB-GRC GEMINI, Créteil, France.
  • Kone-Paut I; ACTIV, Association Clinique et Thérapeutique Infantile du Val-de-Marne, Créteil, France.
  • Deschamps N; Centre Hospitalier Intercommunal, Research Center, Université Paris Est, IMRB-GRC GEMINI, Créteil, France.
  • De Pontual L; Hospices Civils de Lyon, Paediatric Intensive Care Unit, Hopital Femme, Mère Enfant, University of Lyon, Bron, France.
  • Iriart X; EA 7426 "Pathophysiology of Injury-Induced Immunosuppression", University Claude Bernard Lyon 1, Hospices Civils of Lyon, Lyon, France.
  • Guen CG; Department of Paediatric Hematology-Immunology and Rheumatology, Necker-Enfants Malades Hospital, AP-HP, Paris, France, Reference center for Rheumatic, AutoImmune and Systemic diseases in children (RAISE), Paris, France.
  • Angoulvant F; Laboratory of Immunogenetics of Paediatric Autoimmunity, Imagine Institute, Paris University, Inserm U 1163, Paris, France.
  • Belot A; Department of Pediatric Cardiology, Hôpital Timone Enfant, AP-HM, Marseille, France.
Lancet Reg Health Eur ; 17: 100393, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1814915
ABSTRACT

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.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study Topics: Vaccines Language: English Journal: Lancet Reg Health Eur Year: 2022 Document Type: Article Affiliation country: J.lanepe.2022.100393

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study Topics: Vaccines Language: English Journal: Lancet Reg Health Eur Year: 2022 Document Type: Article Affiliation country: J.lanepe.2022.100393