COVID-19 Vaccine Info

Additional COVID-19 Vaccine Dose for Immunocompromised Individuals

Authorization & Recommendation:

• The U.S. Food & Drug Administration and the Centers for Disease Control and Prevention (CDC) have authorized and recommend an additional dose of messenger RNA (mRNA) COVID-19 vaccine for individuals who meet specific conditions and fall into the immunocompromised risk category. The FDA has updated its emergency use authorizations for the Pfizer and Moderna vaccines to include a recommended third dose for individuals with moderate to severe immunosuppression who are at heightened risk for serious outcomes from COVID-19. The purpose of this additional dose is to strengthen the immune response when the initial immune response to the primary two-dose vaccine series is likely to be insufficient, according to the CDC’s Advisory Committee on Immunization Practices (ACIP).
• Other fully vaccinated individuals do not need an additional vaccine dose at this time.
• At this time, an additional dose is not recommended after the single-dose Johnson & Johnson (Janssen vaccine).

When to Consider a 3rd Dose:

• You meet the eligibility criteria listed below;
• It has been at least 28 days following completion of the of the primary vaccination series (28 days after your 2nd dose of Pfizer or Moderna);
• You have talked to your doctor to see if a third COVID-19 vaccine dose is right for you at this time;

Immunocompromised Risk Factors & Eligibility:

• Individuals undergoing active treatment for cancer (solid tumor and hematologic malignancies).
• Individuals who have received a solid-organ transplant and are taking immunosuppressive therapy.
• Individuals who have received a CAR-T-cell or hematopoietic stem cell transplant (within two years of transplant or taking immunosuppression therapy).
• Individuals with moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome).
• Individuals with advanced or untreated HIV infection.
• Individuals undergoing 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, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
• CDC's Updated Clinical Considerations for COVID-19 Vaccinations

Recommendations for COVID-19 Vaccine Providers:

Healthcare providers are urged to consult with immunocompromised patients under their care to offer recommendations for timing of additional doses of COVID-19 vaccine, factoring in their other treatments.

• Individuals who believe they meet the criteria are urged to consult with their healthcare providers to determine next steps. A patient’s clinical team is best positioned to determine the degree of immune system compromise and appropriate timing of vaccination.
• Factors to consider include disease severity, duration, clinical stability, complications, comorbidities, and any potentially immune-suppressing treatment.
• Providers should accept “self-attestation” when eligible individuals present for the additional dose.
• The additional dose should be the same mRNA vaccine as the primary two-dose series. An alternate mRNA product can be used if the primary series product is not available, provided the patient is age-eligible for that product.
• Whenever possible, mRNA COVID-19 vaccination doses (including the primary series and an additional dose) should be given at least two weeks before initiation of immunosuppressive therapies.

Recommended Layered Prevention:

The CDC recommends extra precautions for immunocompromised individuals alongside an additional dose:

• Immunocompromised people (including those who receive an additional mRNA dose) should be aware of the potential for reduced immune response to COVID-19 vaccination and should follow ongoing prevention measures including:
  • Wearing a mask.
  • Staying 6 feet apart from others outside their household.
  • Avoiding crowds and poorly ventilated indoor spaces.
• Close contacts of immunocompromised people are strongly encouraged to be vaccinated against COVID-19.

Booster Doses:

These additional doses for immunocompromised persons should not be confused with booster doses. At this time, additional booster doses are not authorized or recommended for any individuals based upon waning immunity over time. The need for and timing of a COVID-19 booster dose have not been established, according to the FDA.

FDA Resources:

• Pfizer
  • Fact Sheet for Healthcare Providers Administering Vaccine
  • Fact Sheet for Recipients and Caregivers
• Moderna
  • Fact Sheet for Healthcare Providers Administering Vaccine
  • Fact Sheet for Recipients and Caregivers

CDC Resources:

• Considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose COVID-19 mRNA vaccine series for immunocompromised people