Pfizer and BioNTech today said they plan to apply for Emergency Use Authorization of a COVID-19 booster dose for healthy 5- to 11-year-olds based on results of a small study that has not been published or analyzed by independent experts.
Pfizer and BioNTech today said they plan to apply for Emergency Use Authorization (EUA) of a COVID-19 booster dose for healthy 5- to 11-year-olds based on results of a small study that has not been published or analyzed by independent experts.
The companies also plan to request authorization from the European Medicines Agency and other regulatory agencies around the world as soon as possible.
Pfizer said in a press release the third dose of its vaccine produced significant protection against the Omicron variant in children 5 to 11 in a small Phase 2/3 clinical trial.
The study was based on data from only 140 children 5 through 11 years old who received a booster dose six months after the second dose of Pfizer-BioNTech’s COVID vaccine as part of the primary series.
A closer look at 30 children showed a 36-fold increase in virus-fighting antibodies — levels high enough to fight the Omicron variant, ABC News reported.
Pfizer claimed the third dose was “well tolerated with no new safety signals observed.”
Although Pfizer said more than 10,000 children under the age of 12 have participated in clinical trials investigating Pfizer’s COVID vaccine, only 140 were selected for the study forming the basis for the company’s EUA request.