Interim Clinical Consideration for COVID-19 vaccines

2019 AIPO

Important Changes in Interim Clinical Considerations for COVID-19 Vaccines

CDC’s “Interim Clinical Considerations for Use of COVID-19 Vaccines Approved or Authorized in the United States” was updated on November 3, 2021. A summary of recent changes is found at the beginning of the document. Please pay special attention to the following items:

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Timing interval in a two-dose primary series of mRNA COVID-19 vaccines:

Individuals who received the second dose of an mRNA COVID-19 vaccine no more than 4 days before (referred to as the “grace period”) or at any time after the recommended second dose date are considered to have completed the primary series.

  • If the second dose of an mRNA COVID-19 vaccine is given earlier than the 4-day grace period (administered < 17 days [for Pfizer-BioNTech] or <24 days [for Moderna]), the second dose is not counted and should be repeated. This is different from previous recommendations. The repeat dose should be spaced after the dose given in error (i.e. too soon) by the recommended minimum interval. (21 days if Pfizer or 28 days if Moderna). See Appendix A for more details

Timing interval of the additional (3rd) dose of an mRNA COVID-19 vaccine given to moderately and severely immunocompromised people

An additional dose of an MRNA COVID-19 vaccine after an initial 2-dose mRNA COVID-19 vaccine series is needed in moderately and severely immunocompromised people in order to optimize their immune response. This additional dose (i.e., third dose) of an mRNA COVID-19 vaccine should be administered at least 28 days after completion of the initial 2-dose mRNA COVID-19 primary series. See Consideration for COVID-19 vaccination in moderately and severely immunocompromised people

  • If the additional dose of an mRNA COVID-19 vaccine is given fewer than 24 days after the second dose (i.e., administered earlier than the 4-day grace period), the additional dose shouldbe repeated. The repeat dose should be spaced after the dose given in error (i.e. too soon) by the recommended minimum interval. See Appendix A for more details.

People who are moderately and severely immunocompromised MAY receive a booster dose of COVID-19 vaccine

  • Moderately and severely immunocompromised people aged ≥18 years who completed an mRNA COVID-19 vaccine 2-dose primary series and received an additional (3rd) mRNA vaccine dose may receive a single COVID-19 booster dose (Pfizer-BioNTech, Moderna or Janssen) at least 6 months after completing their third mRNA vaccine dose. In such situations, people who are moderately and severely immunocompromised may receive a total of four COVID-19 vaccine doses.
  • Moderately and severely immunocompromised people aged ≥18 years who received a single dose Janssen COVID-19 vaccine primary series should receive a single COVID-19 booster vaccine (Pfizer-BioNTech, Moderna or Janssen) at least 2 months (8weeks) after receiving their initial Janssen primary dose.
    • If the Moderna vaccine is used in this circumstance, the booster dose and dose volume should be used (50µg in 0.25ML).
    • A person who received one primary dose of Janssen COVID vaccine should not receive more than two COVID-19 vaccine doses.