Pfizer Seeks Japanese Approval for COVID-19 Booster in Children Aged 5 to 11

Latest News: Pfizer Applies to Japan's Ministry of Health for Approval of Its COVID-19 Vaccine Booster for Children Aged 5-11.

As early as May this year, Pfizer and BioNTech jointly announced that the U.S. FDA had revised the Emergency Use Authorization (EUA) for their COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, trade name: Comirnaty). The revision approved a booster dose of the vaccine for children aged 5-11 who had completed the two-dose vaccination regimen, to be administered at least five months after the second dose. In JunePfizer/BioNTech COVID-19 Vaccine Expands Eligibility Again, Now for Children Aged 6 Months to 4 Years.

In addition, Pfizer announced on June 15 that the European Medicines Agency (EMA) had initiated a rolling review of the COVID-19 variant vaccine. It plans to submit data on the variant vaccine to the U.S. Food and Drug Administration (FDA) within a few weeks.