FDA Vaccines and Related Biological Products Advisory Committee discuss to amend Pfizer-BioNTech EUA for 5-11 year old children

Watch the discussion and learn how decisions are made here

Introductions of panel members start at 8:55

Dr. Doran Fink presents the topics for discussion at 26:30

The presentations of the meeting: 

  • Epidemiology of COVID-19 in children 50:40
  • Vaccine associated myocarditis 1:28:20
  • Pfizer-BioNTech request 2:24:20
  • FDA review of safety and effectiveness of vaccine in children 3:10:27
  • Post-market active surveillance of COVID-19 vaccines in the pediatric population in the FDA BEST system 3:38:00
  • Benefit-Risk analysis 3:43:22
  • Open Public Hearing 4:36:21
  • Q&A session 5:43:50
  • Committee discussion and voting 6:45:00