ASPR/CDC Monkeypox Vaccination Operational Planning Guide - HHS Monkeypox Vaccination Program
Two FDA-approved smallpox vaccines (JYNNEOS and ACAM2000) are available from the Strategic National Stockpile (SNS) for use as post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) for monkeypox (under the appropriate regulatory mechanism, as applicable).2
JYNNEOS vaccine is FDA-approved for prevention of smallpox or monkeypox disease.3
Globally and in the United States, supply of JYNNEOS vaccine is currently limited.
JYNNEOS should be administered as two injections (two-dose series).
- The two doses should be given 28 days apart (range 24-35 days).
- If the second dose was not given during the recommended interval, it should be given as soon as possible.
- Peak immunity is anticipated 14 days after the second dose.
- JYNNEOS is indicated in people who are determined to be at high risk for smallpox or monkeypox infection. The FDA-licensed administration route is subcutaneous (standard regimen). Under an Emergency Use Authorization beginning August 9, 2022:
- People 18 years of age or older may receive JYNNEOS via intradermal administration (alternative regimen).
- People younger than 18 years old or people of any age who have a history of developing keloid scars may receive JYNNEOS via subcutaneous administration (standard regimen).
- Interim clinical considerations and guidance for use of monkeypox vaccines, including authorized dosing and administration routes, are available from CDC, along with training materials and other related resources for providers. See:
JYNNEOS Vaccine | Monkeypox | Poxvirus | CDC
- JYNNEOS should be prioritized for people who are at high risk for severe disease from monkeypox (including but not limited to people with HIV, pregnant, or other immunocompromising conditions) or serious adverse events with ACAM2000.
- JYNNEOS is safe for administration to people with HIV and atopic dermatitis.
- JYNNEOS is shipped at -20°C and requires cold chain management.
- When stored at -20°C, labeled expiration date applies.
- Expiration dates are found on the carton but not on the vial itself. Expiration dates may also be found at the ASPR website.4
- When thawed and refrigerated at 2°C–8°C temperature, unopened vials can be used for up to 8 weeks based on information provided directly by the manufacturer (this differs from the package insert).5
- JYNNEOS is administered with a needle/syringe; SNS does not provide ancillary supplies.
ACAM2000 vaccine is FDA-approved for the prevention of smallpox disease,6 and is allowed under a CDC-held Expanded Access IND (EA-IND) for the prevention of monkeypox disease.
There is a plentiful supply of ACAM2000.
- ACAM2000 is administered percutaneously as a single dose, using a bifurcated needle.
- ACAM2000 is indicated in adults ages 18 years or older; it has a number of contraindications due to its adverse event profile.
ACAM2000 should not be given to people with the following conditions:
Three or more cardiac risk factors (hypertension, diabetes, hypercholesterolemia, heart disease at age ≥50 years in a first-decree relative, or smoking)
Eye disease treated with topical steroids
Congenital or acquired immune deficiency disorders, including those taking immunosuppressive medications and people living with HIV (regardless of immune status)
Atopic dermatitis/eczema and persons with a history of atopic dermatitis/eczema or other acute or exfoliative skin conditions
Infants less than 12 months of age
Pregnancy and breastfeeding
History of a severe allergic reaction (e.g. anaphylaxis) after a previous dose of ACAM2000
History of severe allergic reaction (e.g. anaphylaxis) to a component of ACAM2000
- ACAM2000 is shipped at -20°C and requires cold chain management.
- Stored at -20°C, unopened vials are good until the printed expiration date
- Once thawed and stored refrigerated at 2°C–8°C, unopened vials must be used within 18 months
- Ancillary kits are provided by SNS
More information on these vaccines can be found at:
Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak | Monkeypox | Poxvirus | CDC.