FDA, CDC OK Pfizer’s COVID-19 Vaccine in Children

The US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) have respectively authorized the emergency use of and endorsed the use of Pfizer’s/BioNTech’s COVID-19 vaccine in children aged five to 11 years old.

The FDA has authorized the COVID-19 vaccine for emergency use (EUA) in children five through 11 years of age. For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. This is the first COVID-19 vaccine authorized in the US for individuals five through 11 years of age.

The EUA is supported by clinical data showing a favorable safety profile and high vaccine efficacy of 90.7% in children five through 11 years of age during a period when the Delta variant was the prevalent strain.

The CDC has endorsed its Advisory Committee on Immunization Practices’ (ACIP) recommendation that children 5 to 11 years old be vaccinated against COVID-19 with the Pfizer–BioNTech pediatric vaccine.

Pfizer and BioNTech say they will begin shipping 10-µg pediatric doses immediately (as reported on October 29, 2021), as directed by the US government, with plans to scale up to full capacity starting the week of November 8, 2021. The companies have also submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators globally, including the European Medicines Agency.

Source: Pfizer, BioNTech, the US Food and Drug Administration, and the US Centers for Disease Control and Prevention