COVID-19 Vaccines: Updated FDA EUA Gave CDC Wiggle Room In Defining Population For Third Shot

Updated EUA for mRNA COVID-19 vaccines left CDC room to define the type of conditions that meet the immunocompromised level described by the FDA. The recommendation for a third shot for immunocompromised patients was based on small studies using surrogates for vaccine efficacy, not hard clinical outcomes. 

Doctor, nurse, scientist hand in blue gloves holding flu, measles, coronavirus, covid-19 vaccine disease preparing for child, baby, adult, man and woman vaccination shot, medicine and drug concept.
FDA and CDC recommended a third mRNA vaccine for immunocompromised patients. • Source: Shutterstock

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously 13 August in favor of administering a third Pfizer Inc. or Moderna, Inc. COVID-19 mRNA vaccine in immunocompromised people, barely 12 hours after the Food and Drug Administration amended the products' emergency use authorization.

The CDC’s recommendations – signed by Director Rochelle Walensky a few hours after the ACIP vote – flesh out in much more detail than the FDA

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