National M​pox Vaccine Strategy
Interim Reporting Guidance

 September 15, 2022

Aggressively responding to the monkeypox outbreak is a critical priority for HHS, and we have launched a rapid and comprehensive response, significantly increasing vaccine supply and distribution, expanding access to tests, making treatments available for free, and educating the public on steps to reduce risk of infection.

From the outset of the current outbreak, the Administration has pulled every lever to stop the spread of the virus, including deploying large quantities of vaccines and treatment drugs from the Strategic National Stockpile (SNS). We have made nearly 1.1 million vials of vaccine available to states and cities across the country. 

HHS is also working with U.S. jurisdictions and with partners to expand vaccination in areas experiencing high numbers of monkeypox cases and contacts.  As of September 14, HHS has delivered more than 803,000 vials of JYNNEOS vaccine to jurisdictions.
 

Distribution of vials in phase 4 of the National Monkeypox Vaccine Strategy began on August 22.

• All orders are placed at the jurisdiction level by the jurisdiction.
• Allocations will be released for ordering in three tranches.
• Each tranche will be comprised of one-third of each jurisdiction's Phase 4 allocation.
• The minimum order quantity (MOQ) for JYNNEOS vaccine is 20 vials (1 box).
• To order against the JYNNEOS allocations in phase 4, there are three requirements for jurisdictions:
• Self-attestation of 85% utilization of product ordered.
• Reporting administration data in the IIS system
• Inventory reporting in HPOP
• For self-attestation: When placing an order in HPOP, jurisdictions will be asked to attest to having utilized at least 85% of vials received to date.
• In attesting that your jurisdiction has used 85% of vials received to date, what should be included?
• When a provider opens a vial and administers even a single shot, that vial is considered used and can be reported as part of that 85%.
• When an entire vial is unusable, the vial should be reported as wastage and can be included in the 85%.
• When a vial is reserved for second doses, that vial is considered used and can be included in the 85%.
• When a vial is further redistributed (beyond the sites that receive a direct shipment), that vial is considered used and can be included in the 85%.
• The jurisdiction is responsible for attesting to 85% use across all sites that received direct shipment of product within the jurisdiction; individual sites do not need to and should not individually attest to 85% use.
• In attesting to 85% usage before ordering more, jurisdictions are helping minimize waste and maximize availability of this important resource.
• Once a tranche is “unlocked" following attestation, jurisdictions can order any portion of the allocated and available vials (MOQ = 20 vials) as needed to resupply.
• Allocations (first, second and third tranches) are not reallocated to other states/jurisdictions.
• Jurisdictions can order the full allocation immediately or draw from the allocation more slowly in accordance with the jurisdiction's vaccination strategy.
• To support optimal placement throughout the jurisdiction, jurisdictions may order a portion of their available vials (versus ordering the entire tranche of available vials) to reach areas of heightened demand and follow with additional orders to stock or re-stock sites as needed.
• Ordering smaller quantities early will aid the jurisdictions in achieving the 85% threshold required for ordering additional vials later and enable sending vials where they are needed most.
• This will help jurisdictions reduce the need to redistribute vials to correct for less-than-optimal placement throughout the jurisdiction.
• Unordered Phase 4 vials will be carried over to the jurisdiction's allocation within the subsequent phase, as with previous phases of the National Monkeypox Vaccine Strategy. Jurisdictions should feel confident to order only those vials needed to supply areas of need as they arise and continue to resupply as needed.
• Please feel free to plan and schedule your vaccine distribution, clinics, second doses, and events knowing that you will receive your full allocation as you continue to use supply per CDC recommendations.
  

Jurisdictions should use the following formula to calculate the utilization rate of 85%:

Administered vials + Wasted vials + Vials reserved for 2nd doses + Vials redistributed
Total # of vials received

The following table displays which metrics should be captured in each reporting requirement.