The filing included data from their phase 2/3 trial in this pediatric age group.
The 2 companies announced late yesterday that they had had filed an Emergency Use Authorization (EUA) with the Food and Drug Administration (FDA) of a 10-µg booster dose of their COVID-19 vaccine for children 5 through 11 years of age.
The filing was based from the data from their phase 2/3 trial, which the companies reported nearly 2 weeks ago, and showed a 36-fold increase in Omicron neutralizing titers following a third dose of their COVID-19 vaccine.
The study had 140 children, between 5-11 years of age, who received the third dose of the vaccine 6 months after the second shot of the Pfizer-BioNTech COVID-19 vaccine. The companies reported a sub analysis of 30 sera from this study indicated that serum antibodies induced by the booster (third dose) neutralized the Omicron variant with a 36-fold increase in neutralizing antibody titers compared to levels seen after 2 doses of their vaccine. The companies said a robust response was observed regardless of prior COVID-19 infection.
They also said there were no new safety signals.
Currently this vaccine is FDA authorized for the following doses:
Vaccine Primary Series