December 9, 2022
Updated HHS Mpox Vaccination Program Provider Agreement
The Centers for Disease Control and Prevention (CDC) has updated the (HHS) Mpox Vaccination Program Provider Agreement to align with CDC’s Mpox Vaccine Interim Clinical Considerations.

JYNNEOS is a third-generation vaccine based on a live, attenuated, and non-replicating orthopoxvirus. During the current outbreak, JYNNEOS is the vaccine used in the United States for preventing mpox among people at increased risk for infection. People who have been exposed or who are at higher potential for exposure to mpox virus may be offered vaccination to help prevent the disease.

JYNNEOS vaccine is licensed as a two-dose series administered 28 days apart. The Food and Drug Administration-licensed regimen is a 0.5mL dose administered subcutaneously. Under an Emergency Use Authorization, an alternative regimen of 0.1 mL administered intradermally was authorized for adults aged 18 years or older. During the height of the 2022 outbreak, the intradermal route was preferred because it safely elicits a similar immune response against mpox and it increased the available supply of vaccine.

The Department of Health and Human Services (HHS) Mpox Vaccination Program Provider Agreement is a legally binding agreement between vaccine providers and HHS. The original provider agreement allowed subcutaneous administration only if intradermal administration is contraindicated, which restricted the ability for providers to offer the vaccine subcutaneously.

CDC’s Mpox Vaccine Interim Clinical Considerations is more permissive than the original provider agreement and indicates that intradermal administration remains the preferred route of administration but should not be a barrier to vaccination.

The update to the provider agreement allows more flexibility for public health jurisdictions and healthcare providers to offer the intradermal or subcutaneous regimen based on balancing optimal vaccine use, patient acceptance, potential stigma from vaccine side-effects, feasibility of administration, and available vaccine supply.

Providers are encouraged to proactively offer vaccine regimen options to patients, especially to individuals who have questions or concerns about intradermal vaccine side-effects such as hyper-pigmentation, swelling, or keloid scarring. Options include alternate intradermal administration in the deltoid or upper back (below the scapula) or subcutaneous administration over the triceps.

The Emergency Risk Communication Branch in the Division of Emergency Operations, Center for Preparedness and Response is responsible for the management of all COCA Products. 
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