Willie R. Tubbs, FISM News
Pfizer and BioNTech have announced they are officially seeking FDA approval to administer a COVID-19 vaccine to children ages 5-11 under emergency use provisions.
The companies made this announcement via a post on Pfizer’s verified Twitter account Thursday.
UPDATE: We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12. pic.twitter.com/72Z2HXlkOx
— Pfizer Inc. (@pfizer) October 7, 2021
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” a follow-up tweet reads.
This is the latest in a series of steps that have occurred as pharmaceutical companies seek to expand the use of their vaccines to younger children, and FDA approval is required before any vaccine can be administered in the U.S.
“We know from our vast experience with other pediatric vaccines that children are not small adults,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement, “and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults.”
Concurrently, companies like Moderna and Johnson and Johnson are working on booster shots for their existing vaccines.
Last week, the FDA announced a trio of meetings that will address the data that has emerged regarding the effectiveness of COVID vaccines and necessity of booster shots.
Moderna and Johnson and Johnson will present data on booster shots to the FDA on Oct. 14 and 15, respectively. Pfizer will present its children’s data on Oct. 26.
If approved the vaccine would be 1/3 the dose of that given to individuals 12 and up.