Pfizer is expected to request authorization for its COVID-19 vaccine for children between the ages of 6 months and 5 years on Tuesday (February 1), which could be granted sometime this month, a person with knowledge of the plan told CNN.
The company will ask the U.S. Food and Drug Administration to grant emergency use authorization for its two-dose coronavirus vaccine as it continues trials for its three doses focused specifically on the age group, the source confirmed.
Federal regulators encouraged Pfizer to seek authorization for the two-dose vaccine on the younger age group and hope for it to be granted by late February, while waiting for data on the three doses to be released may delay authorization to March.
The Pfizer-BioNTech vaccine has already been authorized for use in children as young as 5 and would become the first COVID-19 vaccine approved for the younger age group if the expected upcoming request is granted.
Pfizer extended its vaccine trial in younger children in December after the tests showed the vaccine didn’t produce the expected immunity in children ages 2-5, but did in babies up to age 2, leading to the company saying it would “ammend” the trial by adding a third 3-microgram dose at least two months after the second dose is provided, CNN reports.