There are times when a significant lag between the FDA approval of vaccines and the Centers for Disease Control and Prevention (CDC) recommendation of those vaccines throws any newly approved vaccines into patient access purgatory. Such action has occurred several times in the last few years, as guidance from CDC has taken several months or years to come to fruition after FDA approval.1,2
Unlike medicines or devices, patients and healthcare professionals don’t partake in the benefits of vaccines unless CDC provides guidance on who may receive the vaccines at what specific interval or, at times, provides guidance that does not align with FDA-approved usage. This leaves patients and healthcare professionals in a regulatory twilight zone since the FDA has approved the vaccine as safe and effective while CDC has failed to provide prompt guidance for its use or has provided recommendation contradicting the FDA-approved indication(s).
