CLINICIAN UPDATE--covid-19:

3rd MRNA VACCINE DOSE RECOMMENDED FOR IMMUNOSUPPRESSED PATIENTS: 

Requested Action

• Be aware that the Centers for Disease Control & Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) has recommended a third dose of mRNA COVID-19 vaccine for moderately-to-severely immunosuppressed patients who have completed a two-dose mRNA (Moderna or Pfizer) series.  
• Use electronic medical record or other related tools to identify and notify eligible patients of their eligibility.  
• Dissuade other patients from seeking additional doses of vaccine until the regulatory (FDA) and clinical recommendation (ACIP)  framework supports doing so. 
• Please do not administer or recommend any doses of vaccine for indications outside ACIP’s recommendations, even if your patient requests it.

Further Details

• While CDC recognizes that the patient’s clinical team is best able to assess the degree of altered immunocompetence, it offers the following criteria toward defining moderate-to-severe immunosuppression:
  1. Active treatment for solid tumor and hematologic malignancies
  2. Receipt of solid-organ transplant and currently taking immunosuppressive therapy 
  3. Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy following such treatment)
  4. Moderate or severe primary immunodeficiency (e.g., DiGeorge, Wiskott-Aldrich syndromes)
  5. Advanced or untreated HIV infection
  6. Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, TNF blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
• Use of serologic testing is NOT recommended to assess immune response or determine eligibility.
• The third dose should be administered ≥28 days after the second dose.
• Use of the same product (Moderna or Pfizer) previously given for the first and second dose is recommended, but it is acceptable to administer the complementary product if the homologous one is not available.
• If your eligible patients cannot receive the third dose through your clinic or healthcare system, please refer them to a community-based pharmacy offering COVID-19 vaccination.  A prescription is not required for this indication; self-attestation is sufficient. 
• ACIP members emphasized this recommendation should not be mis-communicated or mis-construed as a recommendation for a booster dose in any other population.  
• Federal public health and medical experts yesterday issued a statement of intent to begin offering these booster doses this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations.   
• At the current time, this recommendation does not apply to recipients of Janssen’s (Johnson-&-Johnson’s) adenovirus vector vaccine.  Further work is underway by CDC staff to permit ACIP to address this question in the near future.  

Additional Resources

• ACIP.  Live Meeting Archive—August 2021.
• ACIP. Presentation Slides: August 13, 2021 Meeting.
• CDC. Altered Immunocompetence.
• IDSA.  Clinical Practice Guideline for Vaccination of the Immunocompromised Host