The U.S. Food and Drug Administration has amended the emergency use authorizations for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals.

The Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices followed the authorization with a recommendation that an additional dose of an mRNA COVID-19 vaccine (Pfizer or Moderna), after an initial two-dose primary mRNA COVID-19 vaccine series, be considered for people with moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments.

These conditions and treatments include but are not limited to: 

  • Active treatment for solid tumor and hematologic malignancies 
  • Receipt of solid-organ transplant and taking immunosuppressive therapy 
  • Receipt of CAR-T-cell or hematopoietic stem cell transplant (within two years of transplantation or taking immunosuppression therapy) 
  • Moderate or severe primary immunodeficiency (for example, DiGeorge syndrome, Wiskott-Aldrich syndrome) 
  • Advanced or untreated HIV infection 
  • Active treatment with high-dose corticosteroids (≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory. 

CDC recommends that a patient's clinical team is best positioned to determine the degree of immune compromise and appropriate timing of vaccination.  

Immunocompromised individuals who have questions about this recommendation should talk to their physician. AHCA/NCAL recommends that providers identify residents (and/or their representatives) who meet the eligibility criteria for being immunocompromised and offer them the third dose or to talk to their physician about receiving a third dose of an mRNA vaccine. Individuals can self-attest and receive the additional dose wherever vaccines are offered.  

While CDC has authorized a third dose for this specific population, individuals only need two doses of an mRNA COVID-19 vaccine to be considered fully vaccinated. Additional doses for people who have received the Janssen (J&J) vaccine are not recommended at this time. Elderly nursing home residents that don't meet the immunocompromised eligibility criteria, do NOT need a third dose at this time.   

In light of this authorization, CDC is working to add new questions on vaccine doses to the National Healthcare Safety Network data collection forms. For technical support, email with “COVID-19 Vaccination Data Reporting" in the subject line.