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

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.
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