Pfizer and its German partner BioNTech SE announced on Thursday that they have submitted files for a full approval of their Covid-19 vaccine for the age group 12 to 15 to the US Food and Drug Administration. Pfizer shots have an emergency permit for age group from 5 to 15 from the FDA.
Pfizer seeks approval based on long-term data from recent adolescent studies. In November, the company announced that a two-dose series of vaccines had been shown to be 100 percent effective against COVID 19, for more than four months after the second dose.
The company is applying for approval of a dose of 30 micrograms of the vaccine for people over the age of 12. The Pfizer / BioNTech vaccine is the only COVID19 vaccine with an approval for emergency usage in the United States for every age group.
Pfizer will file approval applications with the European Medicines Agency and other regulatory agencies around the world within the next few weeks.
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