Your activity: 2 p.v.
< Back

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
  • Unauthorized age group (recipients younger than age 6 months)
  • Do not give another dose at this time.*
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).Δ◊
  • 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.
  • Bivalent vaccine incorrectly administered for the primary series
  • Bivalent Pfizer-BioNTech vaccine: Do not repeat dose.
  • Bivalent Moderna vaccine: Repeat 1 monovalent dose immediately (no minimum interval)◊ because administration of the booster dose will result in a lower-than-authorized dose.
  • Monovalent vaccine incorrectly administered for a booster dose (if bivalent booster indicated)
  • In general, do not repeat dose.
  • However, providers may administer 1 bivalent booster dose as a repeat dose based on clinical judgement and patient preference. In this case, space the repeat dose after the dose given in error by at least 2 months.
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
  • 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).◊
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.◊
  • Any COVID-19 vaccine dose administered at any interval after the recommended interval
  • Do not repeat dose. There is no maximum interval.
  • This deviation from CDC guidance does not require VAERS reporting.
  • Tixagevimab/cilgavimab (Evusheld) administered less than 14 days after COVID-19 vaccination
  • In general, do not repeat vaccine dose. However, based on clinical judgement, a repeat dose of vaccine may be administered at an interval of at least 28 days after the dose of vaccine.◊
Mixed primary series
  • Incorrect COVID-19 vaccine product inadvertently administered as part of a 2- or 3-dose primary series
  • Do not repeat dose.
  • Any combination of Moderna, Novavax, or Pfizer-BioNTech vaccines is considered a complete primary series provided the indicated number of doses is administered.
  • If Janssen vaccine is administered, this counts as a single-dose series and no more primary doses are indicated.
  • Children ages 6 months to 4 years who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered 8 weeks after the second dose to complete the 3-dose primary series.
  • Children ages 5 to 17 years who receive a mixed mRNA COVID-19 vaccine primary series can follow the Pfizer-BioNTech COVID-19 Vaccine schedule and receive a booster dose.
Diluent (Pfizer-BioNTech COVID-19 vaccine formulation only [orange cap and maroon cap])
  • 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.
  • Incorrect diluent type (eg, sterile water, bacteriostatic 0.9% sodium chloride)
  • Contact the manufacturer for information on the stability of the vaccine.§ If the manufacturer does not have information to support the stability of the vaccine, 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.◊
  • 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. Inform patient of the potential for bacterial infection.
Diluent (Pfizer-BioNTech COVID-19 formulation that should not be mixed with diluent, ie, gray cap)
  • Vaccine is mixed with any diluent (ie, any type or volume of diluent)
  • Contact the manufacturer for information on the stability of the vaccine.§ If the manufacturer does not have information to support the stability of the vaccine, 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.

* Do not administer the second dose until the person becomes eligible to receive vaccination (either by reaching the authorized age or if the authorization is extended to include additional age groups), even if this results in the second dose being administered after the recommended interval between doses. In addition to the minimum age, some experts suggest delaying the second dose for 8 weeks after the invalid dose based on the potential for increased reactogenicity and the rare risk of myocarditis and pericarditis from mRNA COVID-19 vaccine.

¶ 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), lead to serious adverse reactions, 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.

Δ For FDA EUA dosing options for children who turn from age 4 years to 5 years (ie, Pfizer-BioNTech), age 5 years to 6 years (ie, Moderna), and age 11 years to 12 years (ie, Moderna and Pfizer-BioNTech) during vaccination, see Transitioning from a younger to older age group. If the dosing is in accordance with the FDA EUA, it is not considered an error and VAERS reporting is not indicated.

◊ Some experts suggest delaying the repeat dose for 8 weeks after the invalid dose based on the potential for increased reactogenicity and the rare risk of myocarditis and pericarditis from mRNA (ie, Moderna or Pfizer-BioNTech) and Novavax COVID-19 vaccines, particularly in groups at increased risk for myocarditis and pericarditis (eg, males ages 12 to 39 years). Individual risk for COVID-19 and the likelihood for an adverse event following vaccination should be taken into consideration when recommending a longer interval. It is acceptable to administer the repeat dose at an interval earlier than 8 weeks if the interval is not sooner than the minimal interval noted in this table.

§ As of the date of this update, current manufacturer contact information is:

  • Pfizer: 1-877-VAX-CO19 (1-877-829-2619)
  • Moderna: 1-866-MODERNA (1-866-663-3762)
  • Janssen: US Toll Free: 1-800-565-4008; US Toll: 1-908-455-9922
  • Novavax: 1-844-NOVAVAX (1-844-668-2829)
Please see the package inserts and EUA provider factsheets for the most up-to-date manufacturer information.

¥ Vaccine doses administered up to 4 days before the minimum interval 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 October 13, 2022).
Graphic 130956 Version 11.0