FDA, CDC push ahead with new COVID-19 boosters for kids without proper data

An opinion by Nicole Saphier, M.D.

The Food and Drug Administration (FDA) has authorized the bivalent COVID-19 booster shots from both Pfizer-BioNTech and Moderna in kids as young as 5 years old. Approval from the Centers for Disease Control and Prevention (CDC) followed in lockstep, as they have for the last two years. 

The new, updated bivalent booster targets the original version of SARS-CoV-2 as well as the currently circulating Omicron variants. The FDA points to their analysis of data from adults who received the Moderna bivalent vaccine and kids who received the old monovalent booster to guide their recent decision. They also said they are approving the Pfizer bivalent vaccine for kids because it is made in a similar fashion to Moderna, despite no supporting data submitted by Pfizer. 

The FDA authorized the bivalent booster for adults in late August without human data. The only available information at the time was from a small study performed on mice. Yet, it was approved, nonetheless. 

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