Pfizer asks FDA to authorize COVID-19 booster shots for children 5-11

April 27 (UPI) -- U.S. Pharmaceutical giant Pfizer said it has asked the United States drug regulator for emergency authorization for booster shots of its COVID-19 vaccine for children 5 to 11 years of age.

Pfizer with its German partner BioNTech said in a statement that they submitted their request Tuesday to the U.S. Food and Drug Administration with data from their Phase 2/3 clinical trial demonstrating "a strong immune response" among those in the targeted demographic who received a booster dose about six months after completing the initial two-dose regimen.

The companies added that they will submit the data to the European Medicines Agency as well as other regulatory agencies in the coming weeks.

The announcement comes nearly two weeks after the companies released clinical trial data from 140 children between the ages of 5 and 11 who have received a booster shot showing a six-fold increase in neutralizing antibodies against COVID-19.

A sub analysis also demonstrated a 36-fold increase in antibodies against the Omicron variant.

More than 10,000 children in all age groups have been enrolled in dozens of Pfizer vaccine clinical trials in the United States, Finland, Poland and Spain

The federal regulators last October first authorized the use of the vaccine for children between 5 and 11 years of age while late last month approving a second booster shot of either the Pfizer-BioNTech or Moderna vaccine for those 50 years old and older.