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 (NYSE:PFE) partner BioNTech SE (NASDAQ: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

Crypto Whales Are Loading Up — Are You?

New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


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Posted In: BiotechNewsHealth CareGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine