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To: Maine Immunization Program Providers
From: Maine Immunization Program
Subject: Monkeypox vaccine transition
Date: August 18, 2022
In preparation to switching over to the alternate Jynneos dosing regimen, the Maine Immunization Program would like to ensure that providers have the most current information and resources to make this change.
On August 9, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the JYNNEOS vaccine. The EUA allows healthcare providers to administer the vaccine by intradermal injection for individuals 18 years of age and older who are at high risk for monkeypox infection, which will result in up to a five-fold increase in the total number of doses available for use.
In addition, the Centers for Disease Control and Prevention (CDC) released Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak that provides guidance for using the alternative (intradermal) regimen, as well as the standard (subcutaneous) regimen for JYNNEOS vaccine.
JYNNEOS administration:
JYNNEOS is recommended to be administered intradermally for people 18 years and older and subcutaneously for people under 18 years of age. Intradermal administration should not be used for those under age 18 or some individuals at risk of keloid.
JYNNEOS Vaccine | Monkeypox | Poxvirus | CDC
Storage and Handling:
If vaccine is received refrigerated and requires storage before use, maintain:
- Refrigerator storage between 2C° and 8°C (between 36°F and 46°F).
- As specified in the note above, refrigerated vaccine is thawed vaccine and must be used within 8 weeks from thawing.
- DO NOT refreeze.
If vaccine is received frozen and requires storage before use, maintain:
- Freezer storage between -25°C and -15°C (between -13°F and +5°F), if freezer capacity is available, OR refrigerator storage between 2°C and 8°C (between 36°F and 46°F).
- If storing vaccine that was received frozen in the freezer, the vaccine should be used within the printed expiration date on the carton. Please note that the expiration date is not shown on the individual vial. Expiration date by lot number can be found at: https://aspr.hhs.gov/SNS/Pages/Monkeypox.aspx.
- If storing vaccine that was received frozen in the refrigerator, it is thawed vaccine and must be used within 8 weeks from thawing. DO NOT refreeze once thawed. It takes about 10 minutes to thaw from -20°C (-4°F).
JYNNEOS Smallpox and Monkeypox Vaccine Storage and Handling Summary (cdc.gov)
IIS documentation and inventory adjustments:
As with the beginning of COVID-19, the importance of timeliness with data entry into ImmPact is crucial for securing allotments of Monkeypox vaccination in the state of Maine. All sites enrolled with the Maine Immunization Program will be required to adhere to the following requirements:
- Reconciliation of inventory is required every 14 days and recommended weekly (be sure to update reconciliation within ImmPact by clicking the submit button).
- Dose administration entry into ImmPact must be completed within 24 hours of administration of any Monkeypox vaccine and no later than 48 hours.
- Temperatures recorded in ImmPact – must be up to date if vaccines need to be transferred to another facility.
- Any vial that is opened and not fully used within 8 hours, please report the wastage as “Open vial but all doses not admin”.
- If a vial did not contain the full 5 doses per vial, please waste out the remaining doses as “Vial did not contain all doses”.
- If you are manually entering data into ImmPact for under 18 years old, you will need to enter the dose amount as 5 doses and subcutaneous.
- Data exchange sites must check and correct any items in their fix tool daily.
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All sites need to be transitioned over to .10 ml dosage by Friday 8/19/2022. Please reconcile and ensure all administrations have been entered in. Once this is completed, please email immpact.support@maine.gov with your site pin number when you are ready.
Should you have any questions, please contact the Maine Immunization Program at (207) 287-3746.
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