• Flexibility in administration route and interchangeability of dosing regimens (10-28-22) Persons 18 and older who are unable or unwilling to receive the JYNNEOS vaccine intradermally should receive the vaccine subcutaneously. See JYNNEOS Vaccine Administration to learn more.
• LAC DPH releases strategy on Addressing Disproportionality in Communities Most Impacted by Monkeypox.

JYNNEOS is a live, non-replicating vaccine that is FDA approved for prevention of smallpox and monkeypox in people ≥18 years administered as a subcutaneous injection. It is also FDA authorized for people ages <18 years. In addition, intradermal vaccination is FDA authorized for people ages ≥18 who do not have a history of keloid formation and is the preferred route of administration for eligible individuals at this time. It is a 2-dose series, with the doses given 28 days apart.

The groups currently eligible for vaccination were selected based on the epidemiology of the current outbreak and may be adjusted based on emerging data. Los Angeles County Department of Public Health (LAC DPH) is partnering with community clinics to provide equitable access to monkeypox vaccine across public and community sites in the County using strategies to improve coverage in communities that are disproportionality burdened by monkeypox.

Eligibility Criteria for JYNNEOS vaccine

A. JYNNEOS vaccine is available for Los Angeles County residents who self-attest to being in one or more of the following groups:

• Any man or transgender person who has sex with men or other transgender persons.
• Persons of any gender or sexual orientation who engage in commercial and/or transactional sex (e.g., sex in exchange for money, shelter, food, or other goods or needs) or have sex in association with a large public event.
• Persons living with HIV, especially persons with uncontrolled or advanced HIV disease.
• Persons who had skin-to-skin or intimate contact with someone with suspected or confirmed monkeypox, including those who have not yet been confirmed by Public Health.
• Sexual partners of people in any of the above groups.
• People who anticipate being in any of the above groups.
  
  Note: residents should not be asked to disclose which eligible group(s) they self-attest to being a part of.

B. Through direct outreach by DPH for select high-risk groups:

• People who have had high- or intermediate-risk contact with someone with monkeypox (as defined by CDC and confirmed by Public Health).
• People who attended an event or venue where there was high risk of exposure through skin-to-skin or intimate contact to individual(s) with monkeypox.
• Persons experiencing homelessness (PEH) with high-risk behaviors.
• People in high-risk cohorts identified by clinical staff in the LA County Jail system.
• Other community groups at high risk of exposure to monkeypox.

C. Persons in select occupational groups who self-attest that their jobs may expose them to orthopoxviruses including:

• Research laboratory personnel working with orthopoxviruses.
• Clinical laboratory personnel performing diagnostic testing for orthopoxviruses.
• Designated public health response team members.
• Health care personnel who administer ACAM2000 (Smallpox [Vaccinia] Vaccine).
• Designated health care workers who care for persons with suspected or confirmed orthopoxvirus infections, including clinicians and environmental services personnel.
  
  Note: the risk of monkeypox transmission remains very low for health care workers if appropriate personal protective equipment is worn and other infection control practices are followed.

For Patients Under 18 years old

The Food and Drug Administration has issued an Emergency Use Authorization and the Centers for Disease Control has released interim clinical guidance including continued use of subcutaneous dosing (0.5ml given 28 days apart) for eligible pediatric populations. Please see the interim clinical guidance for pediatric use of JYNNEOS or contact Department of Public Health (monkeypoxvaccine@ph.lacounty.gov).

Consent at DPH Sites: Minors between the ages of 12-17 years may consent to receive the vaccine by signing the Consent Form for 12-17 Year-olds. Please refer to the DPH justification for more information. Non-DPH vaccine providers should consult with their legal counsel if they choose to adopt this approach. At DPH sites, youth under the age of 12 years must be accompanied by their parent, legal guardian, or a responsible adult, and must have the CDPH MPX Vaccination Registration/Consent Form signed by a parent or legal guardian.

Providers with JYNNEOS vaccine from the Public Health Department should vaccinate their own patients meeting eligibility criteria for monkeypox vaccine. Persons with advanced or uncontrolled HIV are at high risk for severe disease and should be contacted and vaccinated as soon as possible.

Providers that do not have JYNNEOS vaccine should advise patients who meet eligibility criteria to go to a public vaccination site or visit Myturn.ca.gov to find a vaccination site near them.

Second doses: Individuals who received their first dose 28 or more days ago, can go to a public vaccination site, visit Myturn.ca.gov to find a vaccination site near them, or contact their health care provider to obtain their second dose. They may be asked to show their vaccination record.

Individuals without access to internet should be instructed to call the DPH Call Center at 1-833-540-0473.

The information below is to support healthcare providers that are currently providing JYNNEOS vaccination.

LAC DPH has aligned with CDC to allow an alternative regimen (under FDA EUA) to administer JYNNEOS intradermally as a 2-dose series, with an injection volume of 0.1mL, for eligible individuals ≥18 years of age.

With intradermal administration the vaccine is given superficially between the epidermis and the hypodermis layers of the skin, typically of the volar aspect (inner side) of the forearm. If the volar aspect of the forearm is not desired (e.g., patient preference), intradermal administration of vaccine may be performed at the upper back below the scapula or at the deltoid. If a patient is still experiencing erythema or induration at the site of intradermal administration of the first vaccine dose, use the other forearm, deltoid, or upper back. Producing a noticeable pale elevation of the skin (wheal) with the intradermal injection is desirable but not required. Training resources for intradermal administration, including a video and images of the forearm, deltoid and upper back sites are available here. Providers can also contact monkeypoxvaccine@ph.lacounty.gov for assistance.

Eligible individuals under the age of 18 years, and individuals of any age who have a history of keloid formation, should receive subcutaneous injection as a two-dose series with an injection volume of 0.5mL. Additionally, if a patient is unable to or unwilling to receive vaccine via the intradermal route, please offer them vaccination using the subcutaneous route.

NEW: Providers should have both subcutaneous and intradermal vaccine administration options available on site. Although the CDC states that the alternative regimen (intradermal route) is preferred for persons 18 and older without a history of keloids, JYNNEOS vaccine may be administered subcutaneously using the standard regimen. Persons unable or unwilling to receive the vaccine intradermally should receive the vaccine subcutaneously.

Additionally, dosing regimens are interchangeable when necessary. For example, persons who may have received a first dose intradermally, had a robust local reaction, and now refuse the second dose unless given subcutaneously, may receive a second dose subcutaneously.

Vaccination is an important tool in preventing the spread of monkeypox. Because there are limitations in our knowledge about the effectiveness of these vaccines, people who are vaccinated should be encouraged to continue to protect themselves from infection by avoiding close, skin-to-skin contact, including intimate contact, with someone who has monkeypox. See CDC Monkeypox Prevention for more information.

Please refer to the CDC’s interim clinical guidance for additional information, including vaccination schedule, recommended dosing intervals, interchangeability of dosing regimens, and co-administration of JYNNEOS vaccine with other vaccines.

Currently, there are no data on administering JYNNEOS vaccine at the same time as other vaccines. Because JYNNEOS is based on a live, attenuated non-replicating orthopoxvirus, JYNNEOS typically may be administered without regard to timing of other vaccines. This includes simultaneous administration of JYNNEOS and other vaccines on the same day, but at different anatomic sites if possible. However, there are additional considerations if co-administering with a COVID-19 vaccine (see discussion below).

For co-administration best practices and additional details see CDC Coadministration of JYNNEOS Vaccine with Other Vaccines

JYNNEOS and COVID-19 considerations

The CDC provides this guidance:

• If an orthopoxvirus vaccine is offered for prophylaxis in the setting of an orthopoxvirus (e.g., monkeypox) outbreak, orthopoxvirus vaccination should not be delayed because of recent receipt of a Moderna, Novavax, or Pfizer-BioNTech COVID-19 vaccine; no minimum interval between COVID-19 vaccination with these vaccines and orthopoxvirus vaccination is necessary.
• People, particularly adolescent or young adult males, might consider waiting 4 weeks after JYNNEOS vaccination before receiving a Moderna, Novavax, or Pfizer COVID-19 vaccine. This is because of the observed risk for myocarditis and pericarditis after receipt of ACAM2000 orthopoxvirus vaccine and these COVID-19 vaccines and the unknown risk for myocarditis and pericarditis after JYNNEOS vaccination.

LAC DPH Recommendations

Vaccine safety information suggests that although a rare occurrence, there is increased risk of myocarditis and/or pericarditis with Pfizer, Moderna and Novavax COVID-19 vaccinations, particularly in male individuals 12-39 years of age. Prior orthopoxvirus vaccines, specifically ACAM2000, have also been associated with a risk of myocarditis. To date, there have been no reports of increased risk of myocarditis with JYNNEOS vaccine. However, the risk of COVID-19 has been well documented in persons who are under vaccinated, especially those who are 50 and older and those who have underlying medical conditions.

For this reason, LAC DPH recommends the following regarding co-administration of COVID-19 vaccine to persons receiving JYNNEOS vaccination:

• Males 40 years and older and 11 years and younger, and females of any age - Offer COVID-19 vaccination with JYNNEOS vaccine.
  Rationale: Females of all ages and males who are 40 years of age and older, as well as those under 12, have a very low risk of myocarditis associated with COVID-19 vaccines. The benefit of COVID-19 vaccination outweighs the theoretical risk of myocarditis with co-administration of COVID-19 and JYNNEOS vaccine.
• Males 12-39 years of age - Counsel regarding theoretical risk of increased myocarditis with co-administration of these 2 vaccine products. If they agree, both JYNNEOS and COVID-19 vaccinations should be offered.

• To reduce barriers and delays in tuberculosis testing, TST or IGRA can be performed without delay when administratively due or medically indicated, without consideration of timing in relation to JYNNEOS vaccination.
• For TB contacts who had a negative TST or IGRA result within 4 weeks of receiving JYNNEOS or any other live virus vaccination, the TB test should be repeated ≥4 weeks after the last dose of live virus vaccination. It is preferable to use the same TB testing method that was used for baseline testing. The reliability of a positive TST or IGRA result following JYNNEOS or any other live virus vaccination is expected to be the same as without vaccination.
• For patients who have symptoms or signs of active TB disease, all tests and examinations for TB diagnosis should be pursued without delay, regardless of JYNNEOS or any other live virus vaccination.
• Additional details regarding coadministration of JYNNEOS and TB tests can be accessed here.

Registration

If you are interested in becoming a Monkeypox Vaccine provider, please send an email to monkeypoxvaccine@ph.lacounty.gov with the subject “Interested in becoming Monkeypox Vaccine Provider” and include the name of your organization and the approximate number of patients you serve who are eligible for the Monkeypox vaccine.

Providers who DO NOT have a CAIR account will need to be enrolled in CAIR as soon as possible. VPDC can assist your site with obtaining a CAIR ID upon receiving your registration form.

JYNNEOS vaccine is provided at no cost by the US government. Any person accessing the vaccine for administration is subject to compliance with the terms of the Monkeypox Vaccination Program Provider Agreement. By receiving the vaccine, the provider and provider’s organization are deemed to have agreed to comply with the requirements of the Monkeypox Vaccination Program Provider Agreement.

Other Requirements

• Submit data for every vaccine administered through our REDCap OR MyTurn portal.
• Report vaccine inventory weekly through REDCap. Training will be provided on this form as well.
• Store vaccine in a Vaccine For Children compliant storage unit (refrigerator or freezer)
• Monitor storage unit temperatures (current, minimum, and maximum) via Digital Data Logger and document temperatures using VFC Temperature logs (Refrigerator Temp Logs: Fahrenheit | Celsius Freezer Temp Logs: Fahrenheit | Celsius)
• Commit to administering primary series (2 doses) for eligible clients seeking vaccination
• Provide patients with a copy of their vaccine record and vaccine information statement (VIS)

CDC Clinical Resources

• Clinical Considerations for Vaccination
• Monkeypox and Smallpox Vaccine Guidance
• Monkeypox Information for Healthcare Professionals
• Vaccine Administration Errors and Deviations

JYNNEOS^TM Vaccine Information

• MMWR: Use of JYNNEOS (Smallpox and Monkeypox Vaccine, Live Nonreplicating) for Preexposure Vaccination of Persons at Risk for Occupational Exposure to Orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022.
• CDC Monkeypox Interim Vaccine Clinical Considerations
• Demonstration Video on Intradermal Administration
• FDA EUA Fact Sheet for Providers
• FDA EUA Fact Sheet for Patients and Caregivers
• White House Fact Sheet - Key Actions/Implementation Plan to Increase Vaccine Supply
• CDPH JYNNEOS Vaccine Fact Sheet
• JYNNEOS Package Insert
• JYNNEOS Vaccine Information Statement (VIS)

Vaccine Administration, Storage, and Reporting Resources

• JYNNEOS Vaccine Storage and Handling Summary
• Vaccine Administration Site Poster
• Intradermal administration, including video and images
• Injectable Vaccines by Route
• Preparing Liquid Vaccines
• California Immunization Record (Yellow Card) Note: Immunization record does not have to be printed on yellow paper.
• Storage Unit Requirements
• Refrigerator Temp Logs: Fahrenheit | Celsius
• Freezer Temp Logs: Fahrenheit | Celsius
• Digital Data Logger Setup and Use
• Transporting Frozen Vaccine