FDA Says Moderna COVID-19 Vaccine Effective, Safe for Children

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  • U.S. Food and Drug Administration staff reviewers said Friday that Moderna's COVID-19 vaccine is safe and effective for children aged 6 months to 17 years, ahead of a meeting by a team of scientists to determine if the vaccine should be authorized for use in the age group
  • The reviewers said in a report published Friday that the vaccine had generated a similar immune response in children than that seen in adults in previous trials
  • The FDA reviewers further added that the vaccine has a similar side effect profile in chidren as in adults, although some symptoms such as fever occur more frequently in children
  • Researchers had noted a link between the mRNA-based COVID-19 vaccines, including the ones made by Moderna and Pfizer/BioNTech, and a rare type of heart inflammation, mostly in young men
  • The FDA said, however, that it is unable to evaluate the incidence of this rare complication in children due to the small number of the vaccine trials in children