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Interim CDC recommendations for COVID-19 vaccine administration errors and deviations

Interim CDC recommendations for COVID-19 vaccine administration errors and deviations
Type Administration error/deviation Interim recommendation
Site/route
  • Incorrect site (ie, site other than the deltoid muscle or vastus lateralis muscle).
  • Do not repeat dose.
  • Incorrect route (eg, subcutaneous).
  • Do not repeat dose.
  • Inform the recipient of the potential for local and systemic adverse events.
Age
  • 2024-2025 mRNA vaccine administered to an unauthorized age group (recipients younger than age 6 months).
  • If the first dose is administered 5 or more days before age 6 months, repeat the dose on or after the date the recipient reaches 6 months; space the repeat dose at least 4 weeks after the invalid dose.*
  • Novavax vaccine administered to an unauthorized age group (recipients ages 6 months to 11 years).
  • If part of a multidose initial vaccination series (ie, children ages 6 months to 4 years or people ages 6 months and older who are moderately or severely immunocompromised), count the dose; continue the series with a 2024-2025 mRNA vaccine; and space the next dose by at least the minimum interval. If the last dose in the series, no further doses are needed.
  • For children ages 5 to 11 years who are not moderately or severely immunocompromised:
    • If previously received 1 or more doses of any mRNA vaccine, no further doses are needed.
    • If did not previously receive any doses of any mRNA vaccine, administer 1 dose of a 2024-2025 mRNA vaccine at least 4 weeks after the dose given in error.
Product and dosage
  • Higher-than-authorized dose administered (eg, incorrect dose volume, incorrect product resulting in higher-than-authorized dose).
  • Do not repeat dose.Δ
  • Lower-than-authorized dose administered (eg, leaked out of the syringe, equipment failure, recipient pulled away, incorrect product resulting in lower-than-authorized dose).
  • Repeat dose immediately (no minimum interval).
  • However, if a half-volume dose of vaccine is administered to a patient recommended for the full volume, another half-volume dose can be administered on the same clinic day, and the 2 doses can count as 1 full dose.
Storage and handling
  • Dose administered after improper storage and handling (ie, temperature excursion).
  • Contact the manufacturer for information on the stability of the vaccine.◊ If the manufacturer does not have data to support the stability of the vaccine, repeat the dose immediately (no minimum interval).
  • Dose administered past the expiration/beyond-use date.
  • Repeat the dose immediately (no minimum interval).
Intervals
  • Any COVID-19 dose administered prior to the minimum interval.§
  • Repeat dose. Space repeat dose after the dose given in error by at least the minimum interval.
Interchangeability
  • mRNA vaccines from different manufacturers administered as part of an initial vaccination series.
  • Refer to other CDC content for details on dosing intervals.
Diluent (2024-2025 Pfizer-BioNTech COVID-19 Vaccine formulation that should be mixed with diluent)
  • Only diluent administered (ie, sterile 0.9% sodium chloride).
  • Administer the authorized dose immediately (no minimum interval).
  • No diluent, resulting in higher than authorized dose.
  • Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.Δ
  • Incorrect diluent type (eg, sterile water, bacteriostatic 0.9% sodium chloride).
  • Repeat the dose immediately (no minimum interval).
  • Vaccine is mixed with too little diluent.
  • Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.Δ
  • Vaccine is mixed with too much diluent.
  • Repeat dose immediately (no minimum interval).
  • Single-use vial of diluent is used to mix multiple vials of vaccine.
  • Do not repeat dose.
Diluent (2024-2025 Pfizer-BioNTech COVID-19 formulation that should not be mixed with diluent)
  • Vaccine is mixed with any diluent (ie, any type or volume of diluent).
  • Repeat the dose immediately (no minimum interval).

CDC: United States Centers for Disease Control and Prevention; VAERS: Vaccine Adverse Event Reporting System; FDA: US Food and Drug Administration; EUA: emergency use authorization.

* In addition to the minimum age, for children who are not moderately or severely immunocompromised, an 8-week interval between the invalid dose and the repeat dose might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis associated with mRNA (Moderna or Pfizer-BioNTech) COVID-19 vaccines and the potential for increased reactogenicity.

¶ For people ages 6 months to 64 years who are not moderately or severely immunocompromised, an 8-week interval between the dose given in error and the repeat dose might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis associated with Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines, particularly in males ages 12 to 39 years, and the potential for increased reactogenicity.

Δ If the administration error resulted in a higher-than-authorized vaccine dose, in general a subsequent dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile) or are ongoing at the time of the subsequent dose, this dose might be delayed, but this decision should be assessed on a case-by-case basis.

◊ As of August 23, 2024, manufacturer contact information is:

  • Pfizer-BioNTech: 1-877-VAX-CO19 (1-877-829-2619)
  • Moderna: 1-866-MODERNA (1-866-663-3762)
  • Novavax: 1-844-NOVAVAX (1-844-668-2829)

§ Vaccine doses administered up to 4 days before the minimum interval (ie, grace period) may be counted and do not need to be repeated.

Reproduced from: Centers for Disease Control and Prevention. Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates. Available at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us-appendix.html (Accessed on August 30, 2024).
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