The New York State Department of Health (DOH) has issued updated guidance (attached) and a new health advisory (attached) for the administration of a third dose of the Pfizer and Moderna mRNA COVID-19 vaccines to certain individuals with compromised immune systems.
DOH lists clinical criteria that would deem a patient eligible for a third dose, but adds that “a patient’s clinical team is best able to assess the level of immune competence, disease severity duration, clinical stability, complications, comorbidities, and any potential immune-suppressing therapy.”
General Guidelines for Administering Third Doses
- Those eligible for a third dose include individuals who have completed a primary two-dose mRNA vaccine series who are 12 years of age or older who are moderately or severely immunocompromised due to undergoing solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
- The third dose may be administered at least 28 days following the second dose of the two-dose regimen. 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 the 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.
- The age groups authorized for an additional dose remain the same as those for the primary mRNA COVID-19 dose series (Pfizer: aged ≥12 years or Moderna: aged ≥18 years).
- Attempts should be made to match the additional dose type to the mRNA primary series, but if that is not feasible, a heterologous additional dose is permitted.
- There is no requirement for proof of prescription from the individual’s health care provider. Individual self-attestation of having a moderate to severe condition is acceptable.
- Providers should continue to report all doses administered to the New York State Immunization Information System or the Citywide Immunization Registry, including third vaccine doses.
Third Dose Exclusions
The guidance notes that the amended Emergency Use Authorizations (EUAs) do not authorize third doses for fully vaccinated people without immune complications, do not authorize the use of an additional dose of the Janssen/Johnson & Johnson COVID-19 vaccine, and do not support the use of a mRNA COVID-19 vaccine dose after the receipt of the single-dose Janssen/Johnson & Johnson COVID-19 vaccine.
This guidance update follows the US Food and Drug Administration EUA amendments for the Pfizer and Moderna COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC) adoption of the Advisory Committee on Immunization Practices’ (ACIP) clinical recommendation concerning third doses, and the New York State Clinical Advisory Task Force’s recommendation. CDC Interim Clinical Considerations have also been updated to reflect the amendments to the Pfizer and Moderna EUAs and the ACIP recommendation.