Pfizer and BioNTech have officially submitted a request to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their COVID-19 vaccine for children 5 to less than 12 years of age.

The Companies recently submitted data from a phase 2/3 trial that included 2268 pediatric participants who received a lower (10mcg) 2-dose series 21 days apart. Results showed that the 10mcg dose level vaccine elicited strong neutralizing antibody responses, similar to those observed in individuals 16 to 25 years of age who received a 2-dose regimen of 30mcg. The vaccine safety profile was reported to be comparable to that observed in individuals 16 to 25 years of age.

The announcement of EUA submission was made through Pfizer’s Twitter account, in which the Company also noted the continuing rise in COVID-19 infections in children across the US. 

The FDA’s Vaccines and Related Biological Products Advisory Committee is expected to meet on October 26, 2021 to discuss revisions to the EUA allowing for administration of the Pfizer-BioNTech COVID-19 vaccine to this pediatric population. The vaccine is currently authorized for emergency use in children 12 years of age and older.


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Reference

@Pfizer. UPDATE: We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12. Accessed October 7, 2021. https://twitter.com/pfizer/status/1446082946335715334.