Pfizer Officially Requests Approval for Vaccine for Children Aged 5 to 11

The Pfizer-BioNTech alliance has announced the submission of an official request to the U.S. Food and Drug Administration (FDA) for approval of a vaccine for children aged 5 to 11 years. A similar request will be made to the European Medicines Agency and various regulatory authorities there. Pfizer has provided data to the FDA to support their request regarding the vaccine. According to the statement, the vaccine will be administered at a lower dose for this age group compared to that given to adults aged 12 and older. This comes following partial results of a study that included 4,500 children between the ages of six months and 11 years in the United States, Finland, Poland, and Spain. The companies' vaccine, named Comirnaty, has already received authorization for use in children starting from 12 years old in many countries, including the United States. Safety data for the other two age groups in the trial—children from 2 to under 5 years and children from 6 months to under 2 years—is expected as soon as possible in the fourth quarter of this year. Children in the 5 to 11 age group will receive two doses equivalent to one-third of what is given to individuals aged 12 and older.