JYNNEOS Vaccine Distribution by Jurisdiction

Mpox National Vaccine Strategy

The U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR) is making more than 1 million vials of Bavarian Nordic’s JYNNEOS, an FDA-licensed vaccine indicated for prevention of smallpox and mpox (formerly known as monkeypox), available for free to jurisdictions to support their local monkeypox response efforts. 

JYNNEOS was developed with the support of the Biomedical Advanced Research and Development Authority (BARDA) as one element of the federal government’s smallpox preparedness efforts. Prior to the mpox outbreak, the Strategic National Stockpile (SNS) held thousands of vials in its inventory, while millions more – either filled and finished or the equivalent in bulk substance – were stored at the manufacturer’s facility in Denmark. 

On August 9, 2022, the U.S. Food and Drug Administration authorized the emergency use of an alternative dosing approach that allows health care providers to use the vaccine from one vial of JYNNEOS vaccine to protect up to five people when administered intradermally to individuals 18 years of age or older. 

Since the start of the outbreak, ASPR has ordered 5.5 million vials of JYNNEOS from Bavarian Nordic to be filled, finished, and delivered from U.S. government-owned bulk vaccine stored in Denmark, bringing the U.S. government supply to approximately 7 million vials by mid-2023. Under the procurement, Bavarian Nordic agreed to complete a technology transfer that would allow for 2.5 million of those vials to be filled and finished by a U.S.-based contract manufacturer.

HHS declared mpox a Public Health Emergency (PHE) on August 4, 2022. The PHE declaration brought expanded authorities that facilitated a more robust HHS response to the spreading mpox outbreak. Based on the current trajectory of the outbreak, the declaration may not be extended beyond the current expiry of January 31, 2023. HHS will continue to monitor the outbreak and will make JYNNEOS vaccine available to those who may be exposed or at risk for exposure to mpox.

Thresholds and Replenishment by Jurisdiction

Beginning on January 9, 2023, ASPR will transition to a jurisdictional threshold approach. The threshold calculation is based exclusively on each jurisdiction’s estimated percentage of the nation’s population for whom JYNNEOS vaccination is currently recommended. If the calculated threshold for a given jurisdiction was less than the number of vials that jurisdiction had available for ordering from HPOP as of December 12, 2022, the threshold was increased accordingly.

Jurisdictions are already using the threshold process for oral TPOXX and COVID therapeutics. Jurisdictions will continue using the Health Partner Ordering Portal (HPOP) to order against their thresholds.

Jurisdictions can order any quantity of vials available to them up to the threshold. Expanded distribution contracted by the Strategic National Stockpile allows for rapid fulfilment of additional vaccine vials to as many sites as needed. To support optimal placement throughout the jurisdiction, jurisdictions may order a portion of their available vials (versus ordering the entire available supply) to reach areas of heightened demand and follow with additional orders to stock or re-stock sites as needed. Jurisdictions should feel confident to order only those vials necessary to supply areas of need and continue to resupply as needed.

Table 1: JYNNEOS Thresholds by Jurisdiction

JYNNEOS Delivered to Date

Data on JYNNEOS thresholds, orders, and deliveries will be made public monthly.

The below figures are for total vials of JYNNEOS distributed by jurisdiction, ordered, and delivered, and reflect amounts made available before and after the FDA issued the emergency use authorization allowing for intradermal vaccination, which allows for up to five doses per vial. As a result, the number of doses available and / or administered will vary depending on when vaccine was received by a jurisdiction and how it was administered to a patient.

All data in the below table reflects vials of JYNNEOS vaccine.

Table 2: JYNNEOS Vials Delivered by Jurisdiction