01 Nov Mpox Vaccine

Mpox Vaccine

Eligibility

Anyone in Philadelphia who is likely to be exposed to mpox can get the vaccine.

People likely to be exposed to mpox are:

• Gay, bisexual, or other men who have sex with men or transgender, nonbinary, or gender-diverse people who in the past 6 months have had any of the following:
• A new diagnosis of one or more sexually transmitted diseases (e.g., chlamydia, gonorrhea, or syphilis).
• More than one sex partner.
• Individuals who have had any of the following in the past 6 months:
• Sex at a commercial sex venue (like a sex club or bathhouse)
• Sex related to a large commercial event or in a geographic area (city or county for example) where mpox virus transmission is occurring
• People who have a sex partner with any of the above risks
• People who anticipate experiencing any of the above scenarios

Were you exposed to mpox or have a partner with mpox? You should also be vaccinated:

• If you had known or suspected exposure to someone with mpox or you had a sex partner in the past 2 weeks who was diagnosed with mpox.

Vaccine should be received as soon as possible, ideally within 4 days of exposure.

Are you traveling to central or eastern Africa? You should be vaccinated if you are:

• Visiting the Democratic Republic of Congo (DRC) or one of its neighboring countries that has confirmed or suspected mpox cases, like Burundi, Central African Republic (CAR), Congo, Rwanda, or Uganda and you are likely to be exposed, as described above.
• Travel alone does not make someone eligible.

Note: this vaccine can be administered intradermally and may require some additional training of staff to administer appropriately.

Enrollment

To enroll as a mpox provider in Philadelphia, you’ll need to complete the following steps:

• Submit the Enrollment Form via Redcap.
• Review the CDC Provider Agreement and adhere to all requirements.
• Identify two vaccine coordinators. They will need to complete the Online Ordering and the Storage and Handling training.
• Setup your vaccine storage units.
• Setup reporting for vaccines administered (see below).

Once these steps are completed, your site will be able to order mpox vaccine for your patients. If your site sees patients who are eligible for the mpox vaccine, we encourage you to enroll as a provider today!

Enroll today

Reporting

Administered mpox vaccine must be reported to the PDPH PhilaVax Immunization Information System (IIS) within 24 hours.

Mpox Vaccine Specifications

HL7 Reporters

• Confirm that the CVX code is mapped internally allowing for both specifications.
• Trigger two test messages from each location at which you plan to administer the mpox vaccine.
• Send test messages to training environment showing both specifications.
• Once HL7 test messages have been approved by the IIS team, you will report mpox vaccine administration in real time.

Flat File Reporters: Secure File Transport Portal (sFTP)

• Confirm that the CVX code is mapped internally allowing for both specifications.
• Upload a flat file to your designated sFTP account with mpox vaccine administration data.
• A file must be uploaded each day that you administer the vaccine.
• Flat File
• Flat File should meet these standards.
• Flat File reporting template

Storage & Handling

As an mpox vaccine provider, you are required to comply with our storage and handling requirements.

• Vaccine will be transported to your site at refrigerated vaccine temperatures 36 – 46°F (2-8 C) with a beyond use date (BUD) label indicating the date it must be used by. Thawed JYNNEOS vaccine should not be refrozen. JYNNEOS can be stored at refrigerated temperatures for 8 weeks. (Note: this differs from the page insert that come with the vaccine. More information can be found in this letter from the manufacturer).
• JYNNEOS vaccine cannot be stored at room temperature at any time. Immediately replace the punctured vial in the refrigerator.
• Once the vial is punctured, you must discard it after 8 hours.
• Temperature data must be reported every 28 days, when requesting additional dose of mpox vaccine, or whenever there is an out-of-range temperature. File should be emailed to tempcheck@phila.gov. If your site is using a Department of Public Health-provided DDL, the files will also need to be uploaded into PhilaVax.
• All providers must complete our Storage and Handling DDL Training by watching this video and then completing this quiz.
• You can find all of our vaccine storage and handling videos stored on our YouTube channel.

Ordering & Inventory

Ordering instructions

• Please use this form to request quantities of JYNNEOS vaccine for intradermal administration at your practice.
• For your vaccine request to be approved you must:
• Upload your temperature logs to PhilaVax or email them to tempcheck@phila.gov.
• Submit a reconciliation.
• All orders should be submitted on Mondays by 5pm.
• If your request is approved, you can expect to receive JYNNEOS Wednesday or Thursday following your request date. Please make sure you have a contact available to receive the vaccine at your practice.

Please note: If an intradermal route of administration is selected, your allocation of mpox vaccine from the Philadelphia Department of Public Health (PDPH) will include additional vials to account for individuals at risk for developing keloid scars and those under the age of 18 that may need a subcutaneous dose. Additional vials will also be provided to compensate for the fact that most provider are not getting 5 ID doses per vial.

If you have questions about accessing mpox vaccine, email vaccines@phila.gov.

Ordering form

Use our online ordering form to request mpox vaccine.

Order vaccine

Wastage

Wastage should be reported weekly.

Because the vaccine is licensed for one dose per vial, wastage will be considered as any wastage of a full vial of vaccine for any reason. If you administer at least one dose, using either ID or SubQ administration, you do not need to report wastage on that vial.

• Guide: Mpox Vaccine Wastage Guide
• Video: How to add vaccine wastage to PhilaVax

Managing Vaccine Inventory

A mpox inventory has been set-up in PhilaVax to track JYNNEOS doses in sites’ inventory. A reconciliation must be completed weekly (every 7 calendar days).

Inventory will reflect the number of vials currently on hand, not the number of doses.

• Guide to Reconciliation
• Guide: Accepting Shipments in PhilaVax
• Guide: Inventory & Administration Reporting

Administration Resources & Clinical Considerations

Dosage, Administration, and Route

JYNNEOS vaccine is licensed as a series of two doses administered 28 days (4 weeks) apart.

The standard regimen involves a subcutaneous (SubQ) route of administration with an injection volume of 0.5mL. The standard regimen is the FDA-approved dosing regimen. Since August 9, 2022, the standard regimen has been authorized for people aged <18 years under an Emergency Use Authorization.

In the context of the current national Public Health Emergency (PHE), an alternative regimen may be used for people age ≥18 years under an Emergency Use Authorization beginning August 9, 2022. The authorized alternative regimen involves an intradermal (ID) route of administration with an injection volume of 0.1mL.

This approach could increase the number of available JYNNEOS vaccine doses by up to five-fold.

Results from a clinical study showed that the lower intradermal dose was immunologically non-inferior to the standard subcutaneous dose.

Intradermal administration involves injecting the vaccine superficially between the epidermis and the hypodermis layers of the skin, typically of the inner side of the forearm.

Intradermal JYNNEOS administration can be considered for most adults ages 18 years and older. Exceptions include people with a history of developing keloid scars. It is not required to observe patients after vaccination.

• Coadministration of JYNNEOS Vaccine with Other Vaccines
• Intradermal Preparation and Administration Summary
• Clinician FAQs
• Mpox Vaccine Information Statement
• JYNNEOS Vaccine Dose Tracker