Pfizer-BioNTech Submits FDA EUA Application for its COVID-19 Booster for Children 5 Through 11 Years Old

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

• a 2-dose primary series to individuals 5 years of age and older
• a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise

Booster Doses

• a first booster dose to individuals 12 years of age and older who have completed a primary series with the Pfizer-BioNTech COVID-19 vaccine
• a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
• a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
• a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine