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Hyper inflammatory syndrome following COVID-19 mRNA vaccine in children: A national post-authorization

Naïm Ouldali1,2,3,4, Haleh Bagheri5, Francesco Salvo6,7

  • 1Assistance Publique-Hôpitaux de Paris, Department of general paediatrics, paediatric infectious disease and internal medicine, Robert Debré university hospital, Université de Paris, Paris, France.

The Lancet Regional Health. Europe
|May 4, 2022
PubMed

Insights

COVID-19 mRNA vaccines are safe for children, with very few cases of hyper-inflammatory syndrome reported. The risk of this syndrome is significantly lower than multisystem inflammatory syndrome in children (MIS-C) following SARS-CoV-2 infection.

Area of Science:

  • Pediatric immunology
  • Vaccine safety surveillance
  • Infectious disease epidemiology

Background:

  • Multisystem inflammatory syndrome in children (MIS-C) is a severe complication of pediatric SARS-CoV-2 infection.
  • The role of the spike protein in immune activation and MIS-C is suspected.
  • The potential for COVID-19 mRNA vaccines to induce hyper-inflammatory syndrome in children remains unknown.

Purpose of the Study:

  • To assess the risk of hyper-inflammatory syndrome following COVID-19 mRNA vaccination in children aged 12-17.
  • To compare the incidence of vaccine-associated hyper-inflammatory syndrome with the incidence of MIS-C post-SARS-CoV-2 infection in the same age group.

Main Methods:

  • National population-based surveillance of COVID-19 vaccine pharmacovigilance in France.
  • Inclusion of suspected hyper-inflammatory syndrome cases in 12-17-year-olds from June 2021 to January 2022.
  • Case review using WHO MIS-C criteria and comparison of reporting rates with SARS-CoV-2-associated MIS-C.

Main Results:

  • Over 8.1 million vaccine doses administered; 12 cases of hyper-inflammatory syndrome reported.
  • Clinical features included male predominance, cardiac and digestive symptoms, coagulopathy, and shock; all cases recovered.
  • The reporting rate of vaccine-associated hyper-inflammatory syndrome was 1.5 per million doses, significantly lower than the MIS-C rate (113 per million infected children).

Conclusions:

  • Hyper-inflammatory syndrome following COVID-19 mRNA vaccination in children is rare.
  • The low incidence of vaccine-associated hyper-inflammatory syndrome supports the continued use of COVID-19 mRNA vaccines, especially during high SARS-CoV-2 circulation.
Abstract

Keywords:
BNT162b2COVID-19 mRNA vaccineHyper-inflammatory syndromeMultisystem inflammatory syndrome in childrenSARS-COV-2child

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