FDA Says Strong Safety Data A Must For COVID-19 Vaccine Approval For Kids

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  • The FDA said that clinical trials testing COVID-19 vaccines for children are expected to include a monitoring period of at least two months after half the participants get the shots to ensure safety.
  • The comments come as vaccine makers race to submit clinical data seeking regulatory approval for vaccines in children below 12.
  • Earlier on Friday, Pfizer Inc's PFE partner BioNTech SE BNTX said it was set to request global approval to use its COVID-19 vaccine in children as young as five over the next few weeks.
  • Related Content: BioNTech Prepares To Launch COVID-19 Shot For 5 to 11-Year-Old
  • "Children are not small adults – and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults," FDA Acting Commissioner Janet Woodcock said in a joint statement with the director of Center for Biologics Evaluation and Research.
  • Price Action: PFE stock is down 0.86% at $45.64, BNTX stock is up 0.75% at $354 during the market session on the last check Friday.
  • Photo by Daniel Schludi on Unsplash
Posted In: BiotechNewsHealth CareGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
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