Vaccine Administration Errors and Deviations
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Interim recommendations for vaccine administration errors and deviations are summarized in the table below. Providers administering JYNNEOS under the Emergency Use Authorization are required to report vaccine administration errors (e.g., doses inadvertently administered intramuscularly) to the Vaccine Adverse Event Reporting System (VAERS) whether or not they are associated with an adverse event. These should also be reported to the manufacturer, Bavarian-Nordic, at drug.safety@bavarian-nordic.com.
Table 7. Interim recommendations for JYNNEOS vaccine administration errors and deviations
Type
Type
Administration Error/Deviation
Administration Error/Deviation
Interim Recommendation
Interim Recommendation
Site
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).
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.
Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.
Route
Route
Incorrect route resulting in lower-than-authorized dose administered (e.g., inadvertent subcutaneous administration of 0.1 mL when intradermal route was intended).
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.
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
Route
Other incorrect route (e.g., intramuscular administration)
Other incorrect route (e.g., intramuscular administration)
Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.
Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.
Dosage
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.
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.
- 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
Dosage
A lower-than-authorized dose administered subcutaneously (e.g., inadvertent subcutaneous administration of 0.1mL, recipient pulled away, or leakage out of syringe).
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.
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
Dosage
A higher-than-authorized dose administered (e.g., greater than 0.1 mL administered intradermally).
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.
Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events.
Intervals
Intervals
Time interval between first and second dose less than the recommended minimum interval. 1
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
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
Intervals
Time interval between first and second dose greater than the recommended minimum interval.
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.
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
Storage and handling
Dose administered after improper storage and handling (i.e., temperature excursion)
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.
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
Storage and handling
Dose administered past the expiration/beyond-use date
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.
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
- Talking with Patients About Vaccinations
- JYNNEOS Package Insert
- JYNNEOS Vaccine Information Statement (VIS) [151 KB, 2 pages]
- JYNNEOS Vaccine Information Statement (VIS) in Spanish [165 KB, 2 pages]
- Vaccine Storage and Handling Toolkit [70 pages]
- JYNNEOS Standing Orders (Standard Regimen) [233 KB, 3 pages]
- JYNNEOS Standing Orders (Alternative Regimen) [243 KB, 3 pages]
- JYNNEOS Preparation and Administration Summary (Standard Regimen) [134 KB, 3 pages]
- JYNNEOS Preparation and Administration Summary (Alternative Regimen) [139 KB, 3 pages]
- Animated Video: How to administer a JYNNEOS vaccine intradermally (no audio)
- Video: Administering JYNNEOS Intradermally
- Images: Administering JYNNEOS Intradermally [ZIP – 32 MB]
- ACAM 2000 Medication Guide
- Vaccination Operational Planning Guide
- FDA EUA Fact Sheet for Providers [900 KB, 16 pages]
- FDA EUA Fact Sheet for Patients and Caregivers [465 KB, 5 pages]
- FDA EUA Fact Sheet for Patients and Caregivers in Other Languages
- Mpox Vaccination Program Provider Agreement
- JYNNEOS Smallpox and Mpox Vaccine: Patient Screening Form [227 KB, 3 pages]