Vaccination Administration Considerations for Specific Populations
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Table 6. JYNNEOS and ACAM2000 Vaccination Administration Considerations for Specific Populations
Specific Population
Specific Population
JYNNEOS
JYNNEOS
ACAM2000
ACAM2000
Administer 0.5mL subcutaneously, if vaccine is given.
Prior to administration in people younger than 6 months, clinicians should first contact their jurisdictional health department (Jurisdictional Contacts). Jurisdictional health departments can facilitate consultation with CDC if needed.
Administer 0.5mL subcutaneously, if vaccine is given.
Prior to administration in people younger than 6 months, clinicians should first contact their jurisdictional health department (Jurisdictional Contacts). Jurisdictional health departments can facilitate consultation with CDC if needed.
Do not administer to infants age <12 months.
Do not administer to infants age <12 months.
People of any age who have a history of developing keloid scars
People of any age who have a history of developing keloid scars
Administer 0.5mL subcutaneously.
Administer 0.5mL subcutaneously.
Do not administer.
Do not administer.
Most adults age ≥18 years who are eligible for vaccination under the national mpox vaccine strategy (includes PEP, PEP++, or PrEP)
Most adults age ≥18 years who are eligible for vaccination under the national mpox vaccine strategy (includes PEP, PEP++, or PrEP)
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Administer percutaneously if vaccine is given.
Administer percutaneously if vaccine is given.
People with prior history of smallpox vaccination2
People with prior history of smallpox vaccination2
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Can be administered if no contraindication is present.
Can be administered if no contraindication is present.
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Do not administer.
Do not administer.
People with three or more major cardiac risk factors5
People with three or more major cardiac risk factors5
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Do not administer.
Do not administer.
People with atopic dermatitis, eczema, or other exfoliative skin conditions6
People with atopic dermatitis, eczema, or other exfoliative skin conditions6
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Administer 0.1mL intradermally or 0.5mL subcutaneously1.
Do not administer.
Do not administer.
People with prior history of mpox7
People with prior history of mpox7
See footnote about exceptions to the two-dose series.
See footnote about exceptions to the two-dose series.
Do not administer.
Do not administer.
People with congenital or acquired immune deficiency disorders, including those taking immunosuppressive medications and people living with HIV (regardless of immune status)
People with congenital or acquired immune deficiency disorders, including those taking immunosuppressive medications and people living with HIV (regardless of immune status)
Administer as indicated based on age and history of keloids.
(Table 2)
Administer as indicated based on age and history of keloids.
(Table 2)
Do not administer.
Do not administer.
1The JYNNEOS vaccine may be administered subcutaneously using the standard regimen or by using the alternative regimen (intradermal route). The patient and provider may discuss whether to administer the vaccine intradermally or subcutaneously.
2 Previous smallpox vaccination probably does provide some protection, but it may not necessarily be lifelong. During the 2003 mpox outbreak and during the current outbreak, several people who were infected with mpox had previously been vaccinated against smallpox decades prior. In response to the current outbreak, vaccines and other medical measures should be given to eligible people who were previously vaccinated against smallpox.
3 While there are no data for people who are pregnant, animal data do not show evidence of reproductive harm; pregnancy is not a contraindication to receiving JYNNEOS.
4 While there are no data for people who are breastfeeding, animal data do not show evidence of reproductive harm; breastfeeding is not a contraindication to receiving JYNNEOS. It is not known whether JYNNEOS is excreted in human milk. Data are not available to assess the impact of JYNNEOS on milk production or the safety of JYNNEOS in breastfed infants. However, because JYNNEOS vaccine is replication-deficient, it likely does not present a risk of transmission to breastfed infants and can be administered to women who are breastfeeding if vaccination is critical.
5 Presence of three or more of these major cardiac risk factors is a contraindication to vaccination with ACAM2000: hypertension, diabetes, hypercholesterolemia, heart disease at age ≤50 years in a first-degree relative, or smoking. Clinical studies have not detected an increased risk for myopericarditis in recipients of JYNNEOS. However, people with underlying heart disease (e.g., previous myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart conditions) or three or more major cardiac risk factors should be counseled about the theoretical risk for myopericarditis following vaccination with JYNNEOS given the uncertain etiology of myopericarditis associated with replication-competent smallpox vaccines such as ACAM2000.
6 Studies evaluating JYNNEOS in people with atopic dermatitis have demonstrated immunogenicity in eliciting a neutralizing antibody response. No concerning safety signals were revealed.
7 In the context of the current mpox outbreak, and while the supply of JYNNEOS vaccine is limited, the following are exceptions to the recommended two-dose series:
- A person who is diagnosed with mpox after their first dose of JYNNEOS is not recommended to receive the second dose at this time, because mpox infection likely confers additional immune protection.
- A person who would be eligible for vaccination but has been diagnosed with mpox during this outbreak, which started in the United States on May 17, 2022, is not recommended to be vaccinated at this time, because mpox infection likely confers immune protection.
- An immunocompromised person who is diagnosed with mpox after their first dose of JYNNEOS may be eligible to receive the second dose of JYNNEOS on a case-by-case shared decision-making basis based on the clinical judgment of the healthcare provider.
- JYNNEOS Package Insert
- JYNNEOS Vaccine Information Statement (VIS) [151 KB, 2 pages]
- JYNNEOS Vaccine Information Statement (VIS) in Spanish [165 KB, 2 pages]
- Vaccine Storage and Handling Toolkit [70 pages]
- JYNNEOS Standing Orders (Standard Regimen) [233 KB, 3 pages]
- JYNNEOS Standing Orders (Alternative Regimen) [243 KB, 3 pages]
- JYNNEOS Preparation and Administration Summary (Standard Regimen) [134 KB, 3 pages]
- JYNNEOS Preparation and Administration Summary (Alternative Regimen) [139 KB, 3 pages]
- Animated Video: How to administer a JYNNEOS vaccine intradermally (no audio)
- Video: Administering JYNNEOS Intradermally
- Images: Administering JYNNEOS Intradermally [ZIP – 32 MB]
- ACAM 2000 Medication Guide
- Vaccination Operational Planning Guide
- FDA EUA Fact Sheet for Providers [900 KB, 16 pages]
- FDA EUA Fact Sheet for Patients and Caregivers [465 KB, 5 pages]
- FDA EUA Fact Sheet for Patients and Caregivers in Other Languages
- Mpox Vaccination Program Provider Agreement
- JYNNEOS Smallpox and Mpox Vaccine: Patient Screening Form [227 KB, 3 pages]