Opinion: Don’t Weaken the F.D.A.’s Drug Approval Process

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Multisystem Inflammatory Syndrome

This study describes 17 previously healthy children and adolescents who developed a COVID-19-related inflammatory phenotype. The features overlapped but were distinct from those of Kawasaki disease and toxic shock syndrome.

Read the editorial: SARS-CoV-2 – Related Inflammatory Multisystem Syndrome in Children: Different or Shared Etiology and Pathophysiology as Kawasaki Disease?May 21, 2020. ISS. Interim indications on Kawasaki disease and acute multisystem inflammatory syndrome in children and adolescents in the current emergency scenario from SARS-CoV-2 infection. Version 21 May 2020

  • The scientific evidence available to date indicates that SARS-CoV-2 infection occurs in pediatric patients with a clinical course with a very low lethality (0.06% in the age group 0-15 years).
  • However, recent European and US publications describe an acute multisystem inflammatory syndrome in pediatric and adolescent age, associated with positivity for SARS-CoV-2 or the presence of antibodies to SARS-CoV-2, whose precise nosological classification is currently underway.

This syndrome appears to share some clinical features, severe inflammatory response, and some therapeutic options (immunoglobulins, steroids, anticytokine drugs) with Kawasaki disease.

From this, however, it would be distinguished by other peculiarities, represented by the age of the affected subjects, severe multisystem involvement, prevalent myocardial and / or gastrointestinal involvement. 15 May 2020. European Center for Disease Prevention and Control.Rapid risk assessment: Pediatric inflammatory multisystem syndrome and SARS-CoV-2 infection in children

Several countries affected by the pandemic

Recently reported cases of children admitted to the ICU due to a rare pediatric multisystem inflammatory syndrome (PIMS). Presenting signs and symptoms are a mix of those for Kawasaki disease (KD) and toxic shock syndrome (TSS) and are characterized by fever, abdominal pain, and cardiac involvement, among others.

  • A possible temporal association with SARS-COV-2 infection was hypothesized because some of the children tested for SARS-CoV-2 infection were positive for polymerase chain reaction (PCR) or serology.
  • In total, around 230 suspected cases of this new temporally associated pediatric inflammatory multisystem syndrome with SARS-CoV-2 infection (PIMS-TS) were reported in European countries and the UK in 2020, including two deaths, one in the UK. and one in France.

Several countries affected by the pandemicAn outbreak of severe Kawasaki-like disease at the Italian epicenter of the SARS-CoV-2 epidemic: an observational cohort study

In the province of Bergamo, one of the most affected in Italy, Kawasaki-style presentations were managed as Kawasaki disease according to the indications of the American Heart Association. Kawasaki disease shock syndrome (KDSS) was defined by the presence of circulatory dysfunction and macrophage activation syndrome (MAS) according to the criteria of the International Organization of Pediatric Rheumatology. Infection was investigated by quantitative reverse transcriptase PCR in nasopharyngeal and oropharyngeal swabs and by qualitative serological tests that detect respectively IgM and IgG SARS-CoV-2

Ten children diagnosed between February 18 and April 20, 2020: 7 boys and 3 girls; between the ages of 7 and 5, 8 out of 10 were positive for IgG or IgM, or both.

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