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Additional Clinical Vaccine Guidance for Third Dose of mRNA COVID-19 Vaccine
The following message is from Dr. Khaldun, Chief Medical Executive and Chief Deputy Director for Health on additional dose of mRNA COVID-19 vaccine.
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.
The proposed recommendation from ACIP is as follows:
- 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.
- The age groups authorized to receive the additional dose are unchanged from those authorized to receive the primary vaccination series:
- Pfizer-BioNTech COVID-19 vaccine: For persons aged ≥12 years
- Moderna COVID-19 vaccine: For persons aged ≥18 years
The official Morbidity and Mortality Weekly Report (MMWR) has not been released yet but the CDC Director Rochelle P. Walensky, MD, MPH endorsed the use of an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series on August 13, 2021. At this time, the CDC is not recommending additional doses of vaccine for people who were initially vaccinated with the one-dose Janssen vaccine.
Further guidance regarding the considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series for immunocompromised people can be found in the Interim Clinical Considerations for Use of the COVID-19 Vaccines Currently Authorized in the United States.
Michigan has ample supply of the two mRNA COVID-19 vaccines authorized for additional doses after an initial 2-dose primary series of an mRNA COVID-19 vaccine.
We still need every medical provider to do their part to help us end this pandemic. Every eligible health care provider should enroll as a COVID-19 vaccine provider and keep vaccine available in their clinics to vaccinate their patients, including sufficient supply for additional doses for the immunocompromised, and doses for adolescents. More than 3,900 Michigan providers are already registered as “COVID-19 Ready Providers” to administer COVID-19 vaccines. However, more than 3,000 additional providers are eligible and have not yet enrolled. Since we know that people, especially parents and caregivers, trust their own doctor or health care provider most for vaccine information, you continue to play a critical role in answering patient questions, administering the vaccine, and helping to protect immunocompromised populations from COVID-19.
COVID-19 vaccine providers should:
- Be registered in Michigan Care Improvement Registry (MCIR) to provide immunizations and must enroll as a COVID-19 Ready Provider. This includes ensuring your office is ready to administer vaccine to currently eligible populations 12 years of age and older. This will include the provision of additional doses if recommended. Learn more: 3 Steps for Health Care Professionals to participate in the CDC COVID-19 Vaccination Program
- If not currently enrolled, please do so today! If you have any questions or issues with the process, please contact the COVID-19 Provider Enrollment Team at MDHHS_COVIDVaccineProviders@michigan.gov.
- Understand that lack of freezer capabilities should not deter enrollment in the federal program.
- Maximize opportunities to request smaller vaccine amounts from local health department inventories and utilize vaccine cold storage guidance including opportunities to store at lower temperatures for a period of time, per the guidance.
- Assure sufficient supply of vaccine is readily available when someone is able and willing to receive vaccine. It is acceptable to have a vaccine inventory.
- Utilize all opportunities to vaccinate families and others who may be present at places where vaccines are available. This may include staff, family members, or others who may be in close proximity to a vaccination site.
- Maximize the opportunity to vaccinate someone even if some vaccine wastage may occur. There is adequate supply of all three COVID-19 vaccines.
- Look up every person in the Michigan Care Improvement Registry (MCIR) prior to vaccination and assess for other indicated vaccines. ACIP now recommends co-administration of COVID-19 vaccine with other vaccinations. Don’t miss an opportunity to vaccinate.
- Note that vaccinating patients who are not part of your general practice is not a requirement to be a federal COVID provider.
- Actively reach out to your patient base to encourage vaccinations, be prepared to address patient questions to instill vaccine confidence in real time and provide opportunities in every clinical interaction to discuss vaccination opportunities. (https://www.michigan.gov/documents/coronavirus/Parent_FAQs_5.14_Final_725378_7.pdf)