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.