Moderna's COVID-19 Vaccine Shows Safety, Effectiveness For Children Under 17 Years

  • As per the FDA briefing documentModerna Inc's MRNA COVID-19 vaccine appears safe and effective for children aged six months to 17 years old.
  • The FDA's reviewers said that the vaccine had generated a similar immune response in the children than that observed in adults in previous trials.
  • "Available data support the effectiveness of the Moderna COVID-19 Vaccine in preventing symptomatic COVID-19 in pediatric age groups from 6 months through 17 years of age," the FDA staff said.
  • Related: Moderna Concludes FDA Submission For Its COVID-19 Shot In Adolescents, Kids.
  • The FDA staff also said the vaccine generally had a similar side effect profile in children as in adults, although younger children had fevers more frequently.
  • Myocarditis/pericarditis, particularly in the first week following Dose 2, is a known risk associated with the Moderna COVID-19 vaccine.
  • There is no U.S. real-world data for Moderna's shot. But the real-world data from Australia, Canada, and France indicated a similar myocarditis/pericarditis risk compared to individuals 18-24 years.
  • Pfizer Inc PFE / BioNTech SE BNTX shot has also been linked to rare instances of a type of heart inflammation.
  • Read Next: Pfizer/BioNTech's Three-Dose COVID-19 Vaccine Safe, Effective In Younger Kids.
  • The document mentioned that the pediatric trial safety database for mRNA-1273 is not large enough to quantify the frequency of heart inflammation in pediatric age groups. 
  • Price Action: MRNA shares are down 2.45% at $124 during the premarket session on the last check Monday.
  • Photo by mufidpwt via Pixaby

Posted In: BriefsCOVID-19 CoronavirusCOVID-19 VaccineBiotechLarge CapNewsHealth CareGeneral

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