The alliance between companies Fayez and Biontech announced that the US Food and Drug Administration has submitted a formal application for the approval of a vaccine for children aged 5 to 11, while an application will be submitted to the European Medicines Agency and to various regulatory authorities.
Pfizer has provided data to the Food and Drug Administration to support their claim for the vaccine.
According to the statement, the vaccine will be given at a lower dose for this category than that given to adults from 12 years of age. in on.
He claimed that this comes according to the partial results of one studio which included 4,500 children aged six months to 11 years in the United States, Finland, Poland and Spain.
The vaccine from the two companies, called Kommernati, has already been approved for use in children 12 and older in many countries, including the United States.
The highest safety data for the other two age groups of the studio – children from 2 to less than 5 years and children from 6 months to less than 2 years – are expected as soon as possible in the last trimester of quest’year.
Children 5 to 11 years of age will be given two doses equivalent to one third of those given to individuals 12 years of age and older.
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