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Vaccine Administration Errors and Deviations

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Interim recommendations for vaccine administration errors and deviations are summarized in the table below.

Table 7. Interim recommendations for JYNNEOS vaccine administration errors and deviations

Type

Type

Type

Administration Error/Deviation

Administration Error/Deviation

Administration Error/Deviation

Interim Recommendation

Interim Recommendation

Interim Recommendation

Site

Type

Site

Incorrect site (e.g., a site other than triceps or thigh area for subcutaneous administration or a site other than the volar aspect of forearm, upper back below the scapula, or the deltoid for intradermal administrations).

Administration Error/Deviation

Incorrect site (e.g., a site other than triceps or thigh area for subcutaneous administration or a site other than the volar aspect of forearm, upper back below the scapula, or the deltoid for intradermal administrations).

Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.

Interim Recommendation

Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.

Route

Type

Route

Incorrect route resulting in lower-than-authorized dose administered (e.g., inadvertent subcutaneous administration of 0.1 mL when intradermal route was intended).

Administration Error/Deviation

Incorrect route resulting in lower-than-authorized dose administered (e.g., inadvertent subcutaneous administration of 0.1 mL when intradermal route was intended).

Repeat dose immediately via intended route (no minimum interval). Repeated dose should be placed at least 2 inches away from the inadvertent site placement.

Interim Recommendation

Repeat dose immediately via intended route (no minimum interval). Repeated dose should be placed at least 2 inches away from the inadvertent site placement.

Route

Type

Route

Other incorrect route (e.g., intramuscular administration)

Administration Error/Deviation

Other incorrect route (e.g., intramuscular administration)

Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.

Interim Recommendation

Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.

Dosage

Type

Dosage

A lower-than-authorized dose administered intradermally (e.g., recipient pulled away, or leakage out of the syringe)

NOTE: Absence of a wheal without vaccine leakage may be counted as valid administration.

Administration Error/Deviation

A lower-than-authorized dose administered intradermally (e.g., recipient pulled away, or leakage out of the syringe)

NOTE: Absence of a wheal without vaccine leakage may be counted as valid administration.

  • Repeat intradermal dose immediately (no minimum interval) at least 2 inches away from the site of vaccine leakage.
  • If vaccine leakage occurs with two intradermal vaccinations on the same day, administer 0.5mL subcutaneously.
Interim Recommendation
  • Repeat intradermal dose immediately (no minimum interval) at least 2 inches away from the site of vaccine leakage.
  • If vaccine leakage occurs with two intradermal vaccinations on the same day, administer 0.5mL subcutaneously.

Dosage

Type

Dosage

A lower-than-authorized dose administered subcutaneously (e.g., inadvertent subcutaneous administration of 0.1mL, recipient pulled away, or leakage out of syringe).

Administration Error/Deviation

A lower-than-authorized dose administered subcutaneously (e.g., inadvertent subcutaneous administration of 0.1mL, recipient pulled away, or leakage out of syringe).

Repeat dose immediately with the correct dose (no minimum interval). Repeated dose should be placed at least 2 inches away from the site of previous injection or at another site.

However, if a partial dose of vaccine is administered to a patient instead of the intended full volume, the remainder of the dose can be administered on the same clinic day, and the 2 portions can count as 1 full dose.

Interim Recommendation

Repeat dose immediately with the correct dose (no minimum interval). Repeated dose should be placed at least 2 inches away from the site of previous injection or at another site.

However, if a partial dose of vaccine is administered to a patient instead of the intended full volume, the remainder of the dose can be administered on the same clinic day, and the 2 portions can count as 1 full dose.

Dosage

Type

Dosage

A higher-than-authorized dose administered (e.g., greater than 0.1 mL administered intradermally).

Administration Error/Deviation

A higher-than-authorized dose administered (e.g., greater than 0.1 mL administered intradermally).

Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.

Interim Recommendation

Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.

Intervals

Type

Intervals

Time interval between first and second dose less than the recommended minimum interval. 1

Administration Error/Deviation

Time interval between first and second dose less than the recommended minimum interval. 1

Repeat dose after the dose given in error by at least the recommended interval of 28 days if the patient is severely immunocompromised.2 Otherwise, do not repeat dose.1

Interim Recommendation

Repeat dose after the dose given in error by at least the recommended interval of 28 days if the patient is severely immunocompromised.2 Otherwise, do not repeat dose.1

Intervals

Type

Intervals

Time interval between first and second dose greater than the recommended minimum interval.

Administration Error/Deviation

Time interval between first and second dose greater than the recommended minimum interval.

Do not restart the series.  Administer the second dose as soon as possible. While available clinical data show that the second dose may be given up to 7 days after the minimum interval of 28 days (i.e., 35 days after the first dose), there is no maximum interval and the second dose should be given as soon as possible to complete the series.

Interim Recommendation

Do not restart the series.  Administer the second dose as soon as possible. While available clinical data show that the second dose may be given up to 7 days after the minimum interval of 28 days (i.e., 35 days after the first dose), there is no maximum interval and the second dose should be given as soon as possible to complete the series.

Storage and handling

Type

Storage and handling

Dose administered after improper storage and handling (i.e., temperature excursion)

Administration Error/Deviation

Dose administered after improper storage and handling (i.e., temperature excursion)

Contact the manufacturer2 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 using a new vial that has been properly stored and handled.

Interim Recommendation

Contact the manufacturer2 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 using a new vial that has been properly stored and handled.

Storage and handling

Type

Storage and handling

Dose administered past the expiration/beyond-use date

Administration Error/Deviation

Dose administered past the expiration/beyond-use date

Contact the manufacturer2 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 using a new vial that has been properly stored and handled, and is not past the expiration date.

Interim Recommendation

Contact the manufacturer2 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 using a new vial that has been properly stored and handled, and is not past the expiration date.

1Vaccine doses administered up to 4 days before the minimum interval may be counted and do not need to be repeated.
2Contact information for manufacturer:

  • Email: medical.information_US@bavarian-nordic.com
  • U.S. phone number: 1-844-422-8274
  • U.S. fax number: 1-843-422-8274