4:13 PM, Feb 27, 2020


Pfizer submits request for FDA to authorize COVID-19 vaccine for kids ages 5-11

Pfizer vaccine
Posted at 1:15 PM, Oct 07, 2021
and last updated 2021-10-07 13:15:27-04

(WXYZ) — Pfizer and BioNTech have officially submitted a request to the Food & Drug Administration to give emergency use authorization to its COVID-19 vaccine for kids between the ages of 5 and 12.

On Thursday morning, the company tweeted they had made the formal request, which comes just over a week after the companies submitted initial data from the FDA on the clinical trial for the vaccine in kids.

According to the companies, the pivotal trial included 2,268 participants between the ages of 5 and 12.

"The vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen," Pfizer said in a release.

The vaccine given to children in the 5 to 12 age group is a slightly smaller dose than the shot given to adults.

Earlier this month, the company said that data showed that children developed virus-fighting antibodies about as well as adults who received two typical shots of the vaccine.

Currently, the vaccine is approved for use in people ages 12 and up.

The FDA has a meeting scheduled on Oct. 26, in which they are expected to consider the EUA request, and a decision is expected to come after that.

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