Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

FDA may authorize COVID-19 vaccine for kids based on two months of safety data. The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request FDA emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks.

U.S. 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.

Pfizer and partner BioNTech SE as well as Moderna Inc are racing to submit clinical data seeking regulatory approval for their vaccines in children below 12 years of age. 

Pfizer/BioNTech's vaccine has been currently authorized for children aged 12 to 15 in the United States.

·        Pfizer said it expects to report data needed for approval in 5 and 11 year olds sometime this month and could potentially submit an application for emergency use shortly after. The drug maker said data for kids aged 2 and under 5 could arrive soon after.

·        For children between 6 months and 2 years, Pfizer has said it could have a safety and immunogenicity data as early as October or November.

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