US FDA may authorize COVID-19 vaccine for kids based on two months of safety data

us fda may authorize covid 19 vaccine for kids based on two months of safety data

Sumary of US FDA may authorize COVID-19 vaccine for kids based on two months of safety data:

  • US heath regulators said children in clinical trials testing COVID-19 vaccines should be monitored for at least two months for side effects, suggesting that the agency is considering a quicker path to authorize the shot for emergency use than full approval.
  • The FDA granted full approval last month for the use of Pfizer Inc’s vaccine in people over the age of 16 based on a six-month follow-up from the trial.
  • Pfizer and partner BioNTech as well as Moderna are racing to submit clinical data seeking regulatory approval for their vaccines in children below 12 years of age.
  • Pfizer said it expects to report data needed for approval in five- and 11-year-olds sometime this month and could potentially submit an application for emergency use shortly after.

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