FDA Guidance on Third Dose of Covid Vaccine for the Immunocompromised

The Food and Drug Administration (FDA) released anticipated guidance on providing additional doses of COVID-19 vaccine to specific patient populations on August 12th. The revised guidance recommends an additional (third) dose of Pfizer/BioNTech or Moderna vaccine for individuals who are immunocompromised, specifically individuals who have received an organ transplant. 

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"The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease," acting FDA Commissioner Janet Woodcock said. "Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19."

On August 3rd, 2021, the National Council for Prescription Drug Plans (NCPDP) released an updated version of the NCPDP Emergency Preparedness Guidance v1.10. This document has been updated to provide claim submission guidance for additional COVID-19 vaccine doses. 

NCPDP distinguishes between ‘additional doses’ and ‘boosters’ in the following way: “an additional dose is defined as an additional dose of vaccine given to a targeted population from the same formulation of vaccine currently on the market. New formulations of a vaccine [“booster” vaccines] would have a different NDC and do not constitute an additional dose under this definition.” 

According to the recent joint CDC and FDA statement on vaccine boosters, individuals “who have been fully vaccinated do not need a booster shot at this time.” The FDA, in collaboration with other health agencies, is currently investigating whether and when boosters may be needed.     

When submitting claims for additional doses of vaccine, NCPDP recommends the SCC value of 7 “Medically Necessary” to identify the claim as an additional dose.   

FrameworkLTC customers: we have you covered! Visit the Help Center for more information on this recent development and how you can manage this update with FrameworkLTC Vaccine Management.