Pfizer-BioNTech Seek EUA for COVID-19 Vaccine for Children Ages 5-11

On Thursday, Pfizer and BioNTech announced they have submitted a formal request to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of its COVID-19 mRNA vaccine among children ages 5-11. Up to 28 million children nationwide could become eligible upon authorization.

Recall, Pfizer and BioNTech received full FDA approval for its COVID-19 vaccine for persons ages 16 and older. The FDA has granted an EUA for the vaccine for children ages 12-15. The formal request submitted this week follows data provided to the federal government last month indicating favorable effectiveness and safety among children 5-11.

The FDA Vaccines and Related Biological Products Advisory Committee has set a meeting for October 26 to review the firms’ EUA request. Additional information is anticipated later this month.