Additional doses for people 5 years and older with moderate to severe immune compromise

The Food and Drug Administration has amended the Emergency Use Authorization for the two messenger RNA (mRNA) COVID-19 vaccines - Pfizer and Moderna - authorizing an additional vaccine dose  (“3rd dose”) to people with moderate to severe immune compromise from a medical condition or who receive immunosuppressive medication or treatment. 

People who are immunocompromised due to medical conditions or immunosuppressive medication or treatment are at increased risk of severe illness from COVID-19. There is growing evidence that these individuals may have a decreased or negligible immune response after vaccination with the primary 2-dose mRNA vaccine series. 

Recent studies suggest an additional dose of the mRNA vaccine in immunocompromised adults improves antibody response after vaccination. Studies show the side effect profile after the 3rd dose is similar to the side effects reported after receiving the primary 2-dose mRNA series. At this time, there are no studies on the efficacy of the additional dose in preventing COVID-19. 

In light of the emerging evidence that an additional dose of the mRNA vaccine in individuals with moderate to severe immune compromise has the potential to increase immune response for this vulnerable population, the Baltimore City Health Department recommends vaccine providers follow the Centers for Disease Control Interim Clinical Considerations for COVID-19 vaccination and offer an additional dose of the mRNA vaccine to individuals with moderate to severe immune compromise. 

An additional mRNA vaccine dose should be offered to individuals with moderate to severe immunocompromising conditions and/or taking immunosuppressive medication or treatments. These conditions and medications/treatments include, but or 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 2 years of transplantation or taking immunosuppression therapy)

  • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)

  • Advanced or untreated HIV infection

  • 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.

An additional dose of the Moderna vaccine can be given to individuals 18 years and older who met the above criteria. An additional dose of the Pfizer vaccine can be given to individuals 5 years and older who meet the above criteria. The additional dose can be given 28 days after completion of the primary 2-dose mRNA series.

The additional dose should be the same vaccine product as the initial 2-dose mRNA primary series. However, if the initial 2-dose mRNA product is not available, the other mRNA COVID-19 vaccine product can be given. 

Serologic testing and cellular immune testing prior to administration of the additional dose is not recommended at this time. Baltimore City Health Department will not require a medical provider’s note or prescription for the administration of an additional dose.  Resident self-attestation of having a moderate to severe immunocompromising condition qualifying them for an additional dose will be honored.  

Based on the evidence showing a limited immune response after COVID-19 vaccination in this population, providers should recommend individuals with moderate to severe immunocompromising conditions continue to practice non-pharmaceutical interventions - wearing a mask, remaining 6 feet apart from others, avoiding large crowds, and poorly ventilated areas. Providers should strongly recommend COVID-19 vaccination for close contacts of individuals with immunocompromising conditions. 

We recommend residents with immunocompromising conditions or taking medication that suppresses the immune system talk with their clinical provider about the need for an additional dose of the mRNA COVID-19 vaccine. Clinical providers are best equipped to make informed decisions about their patient's medical conditions and the timing of the additional dose of the mRNA vaccine. 

At this time, there is no evidence to recommend an additional dose after a primary Johnson & Johnson vaccine dose in immunocompromised individuals.

The Baltimore City Health Department will continue to monitor updates, and adjust guidance, as more information arises.  

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