|
|
Correction: This newsletter is being re-sent to correct an error about the number of residents who received a vaccine in the state. It has been changed to the number of COVID-19 doses administered in the state. The clinical guidance remains unchanged.
Please note: The clinical considerations for use of an additional dose of an mRNA COVID-19 vaccine apply only to people who are moderately or severely immunocompromised. Consideration for an additional dose of mRNA COVID-19 vaccine should be given to those in this population—the moderately or severely immuncompromised. There is no age criteria to the guidance regarding an additional dose of mRNA vaccine. Clinicians should use their best clinical judgement in determining if their patient meets this eligibility criteria.
No special attestation is required by the patient or their medical provider, and MDHHS will not be asking COVID-19 vaccine providers to verify eligibility for patients receiving a third dose (a prescription or other verification is not required). COVID-19 providers should work to remove any potential barriers to accessing a third dose for eligible people.
Additional Dose of mRNA COVID-19 Vaccine
A message from Dr. Khaldun, Chief Medical Executive and Chief Deputy Director for Health
In the eight months since COVID-19 vaccines became available, more than 9 million doses have been administered and more than half of Michiganders 12 years of age and older are completely vaccinated, thanks to the extraordinary efforts of public health officials and providers like you.
On August 12, 2021, the Food and Drug Administration (FDA) modified the Emergency Use Authorization (EUA) to allow for the administration of an additional dose (i.e., third dose) of an mRNA COVID-19 vaccine after an initial 2-dose primary mRNA COVID-19 vaccine series. The additional dose of mRNA COVID-19 vaccine is for certain immunocompromised individuals.
On August 13, 2021, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization practices (ACIP) unanimously voted in favor of recommending an additional dose of an mRNA COVID-19 vaccine dose for certain immunocompromised individuals.
The clinical considerations for use of an additional dose of an mRNA COVID-19 vaccine apply only to people who are moderately or severely immunocompromised. Clinicians should use their best clinical judgement in determining if their patient meets this eligibility criteria. No special attestation is required by the patient or their medical provider, and MDHHS will not be asking COVID-19 vaccine providers to verify eligibility for patients receiving a third dose. COVID-19 providers should work to remove any potential barriers to accessing a third dose for eligible people.
|
|
|
mRNA COVID-19 Vaccines
The age groups authorized to receive the additional dose are unchanged from those authorized to receive the primary vaccination series:
Emergency Use Authorization (EUA) for mRNA Vaccines
Both mRNA COVID-19 vaccines under EUA in the U.S. were amended to reflect the FDA authorized and ACIP recommended additional dose of mRNA COVID-19 vaccine for certain immunocompromised individuals.
Use the Michigan version of the EUAs:
ACIP Recommendation for the Additional mRNA COVID-19 Vaccine Dose
One additional dose of mRNA COVID-19 vaccine is recommended for certain immunocompromised individuals after an initial 2-dose primary series of an mRNA COVID-19 vaccine has been received.
What Brand Can the Additional mRNA COVID-19 Vaccine Dose Be?
Attempts should be made to match the additional mRNA COVID-19 vaccine dose to the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series. However, if the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses.
Due to insufficient data, the emergency use authorization (EUA) amendment for an additional dose does NOT apply to Janssen COVID-19 vaccine or to individuals who received Janssen COVID-19 as a primary series. CDC and FDA are actively engaged to ensure that immunocompromised recipients of Janssen COVID-19 vaccine have optimal vaccine protection
|
|
Timing of Additional Dose
The additional dose of an mRNA COVID-19 vaccine should be administered at least 28 days after completion of the initial 2-dose mRNA COVID-19 vaccine series.
Who is Considered Immunocompromised
Data have found evidence of reduced immune response to a 2-dose primary mRNA COVID-19 vaccine series in some groups of immunocompromised individuals. An additional dose of an mRNA COVID-19 vaccine after an initial 2-dose primary mRNA COVID-19 vaccine series should 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 2 years of transplantation or taking immunosuppression therapy)
- Moderate or severe primary immunodeficiency (e.g., DiGeorge, Wiskott-Aldrich syndromes)
- 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, TNF blockers, and other biologic agents that are immunosuppressive or immunomodulatory
Factors to consider in assessing the general level of immune competence in a patient include disease severity, duration, clinical stability, complications, comorbidities, and any potentially immune-suppressing treatment.
Additional information about the level of immune suppression associated with a range of medical conditions and treatments can be found in:
|
|
Additional Clinical Considerations to Note for the Additional mRNA COVID-19 Vaccine Dose
- Whenever possible, mRNA COVID-19 vaccination doses (including the primary series and an additional dose) should be completed at least two weeks before initiation or resumption of immunosuppressive therapies, but timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies and optimization of both the patient’s medical condition and response to vaccine.
- A patient’s clinical team is best positioned to determine the degree of immune compromise and appropriate timing of vaccination.
- The utility of serologic testing or cellular immune testing to assess immune response to vaccination and guide clinical care (e.g., as part of need assessment for an additional dose) has not been established. Serologic testing or cellular immune testing outside of the context of research studies is not recommended at this time.
Reinforcement for the Need for Prevention Measures Among Immunocompromised Individuals
Immunocompromised individuals, including those who receive an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series, should be counseled about the potential for a reduced immune response to COVID-19 vaccine and the need to continue to follow current prevention measures such as:
- Wear a mask
- Stay 6 feet apart from others they don’t live with
- Avoid crowds and poorly ventilated indoor spaces until advised otherwise by their healthcare provider
It is important that close contacts of immunocompromised people be vaccinated against COVID-19. Strongly encourage close contacts to complete their COVID-19 vaccine series to provide another layer of protection for their immunocompromised loved one.
|
|
Michigan Care Improvement Registry (MCIR) Reminder
Every patient’s MCIR record must be assessed prior to vaccination. All administered doses must be reported within 24 hours of vaccination.
Coding Information
COVID-19 Vaccine coding information from the Centers for Medicare & Medicaid Services (CMS). — CMS.gov
Sources
|
|
|
|
