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Update for Clinicians on Testing and Treatment for Monkeypox.  

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As of July 28, 2022, the Centers for Disease Control and Prevention (CDC) and state and local public health partners are reporting 5,189 cases of monkeypox in the United States across 47 states, Washington, D.C., and Puerto Rico. Globally, 22,141 monkeypox cases have been identified across 72 countries that normally do not report monkeypox. In Louisiana, 49 monkeypox cases have been detected as of August 1, 2022. Monkeypox cases in Louisiana have been identified across 4 of the 9 Louisiana Department of Health (LDH) regions.

This Health Alert Network (HAN) Health Update serves to alert clinicians on commercial testing capability, collecting clinical specimens for testing, using TPOXX® (tecovirimat) for treating monkeypox, and vaccine eligibility and availability in Louisiana.

Recommendations for Healthcare Providers on Diagnostic Testing

Healthcare providers in Louisiana should be on alert for patients who have rash illnesses 

. Distinguishing features of the rash include papules, vesicles, pustules, or scabs that are deep-seated, firm or rubbery, and have well-defined round borders. Vesicular or pustular 

 are often umbilicated (i.e., have a dent in the middle of them). They may be painful, painless, or itchy. People with monkeypox may develop 

 including fever, headache, muscle aches, exhaustion or swollen lymph nodes during the prodromal period preceding the rash or with the rash.

The public health response to monkeypox depends on timely and comprehensive laboratory testing and reporting of those results. Tests should be performed on persons for whom monkeypox is suspected based on clinical presentation and 

. Positive diagnostic results from testing of skin lesion material for 

DNA in persons without epidemiologic criteria or known risk factors should be verified through repeat testing and/or confirmatory testing.

If there are no identified epidemiologic risk criteria for monkeypox infection, other possible causes of rash in adults should be considered, including secondary syphilis, herpes, and varicella zoster. In children without identified epidemiologic risk criteria for monkeypox, varicella zoster and molluscum contagiosum (MC) should be considered in the differential diagnosis. MC is an infection caused by a poxvirus (molluscum contagiosum virus) that is diagnosed more often in children than in adults. 

 is usually a benign, mild skin disease characterized by lesions that may appear anywhere on the body. CDC’s FDA-cleared non-variola virus test used within the Laboratory Response Network laboratories and most commercial laboratories, does not cross-react with molluscum contagiosum virus. In children and adolescents, as in adults, other potential etiologies of illness should be tested for in parallel with or before 

testing, based on clinical presentation and epidemiologic criteria.

The recommended specimen type is material collected from the surface of a lesion or crust from a healing lesion. CDC recommends that three lesions per patient be swabbed. Swab the surface of the lesion vigorously to collect adequate DNA. It is not necessary to de-roof or lance the lesion before swabbing. For some individuals, the lesions may not be overtly visible (such as within the oral cavity or within the rectum), therefore clinicians should perform a thorough evaluation including a full body skin, oral, genital, and rectal examination to identify appropriate lesions for sampling.

To build upon CDC’s and the Laboratory Response Network’s testing capacity, CDC recently worked to bring testing online at five commercial laboratory companies. All five commercial laboratories are now online and, combined with the CDC’s Laboratory Response Network, have increased national 

testing capacity from 6,000 to up to 80,000 specimens per week.† It is not necessary to first consult with state or federal health officials prior to initiating diagnostic testing at commercial laboratories.

Non-variola orthopoxvirus testing continues to be available through the State Public Health Laboratory (SPHL). Providers requesting testing through the SPHL should call the Infectious Disease Epidemiology (IDEpi) 24/7 clinician hotline (800-256-2748) for specimen collection instructions and courier transport.

Once results are received from the laboratory, a positive 

 test is considered to meet the case definition for probable 

infection since there are no other circulating 

within the United States that cause systemic disease. Clinical care and prevention precautions should begin based on the 

 test result and should not wait for any additional viral characterization testing that may be performed.

Information for Healthcare Providers on Tecovirimat Treatment

Tecovirimat (also known as TPOXX or ST-246) is approved by the Food and Drug Administration (FDA) for treating human smallpox disease caused by 

 in adults and children. Its use for other 

infections, including monkeypox, is not approved by the FDA. However, CDC has an 

expanded access Investigational New Drug application

 (EA-IND) to allow access to and use of TPOXX to treat monkeypox in adults and children of all ages.

The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs. The EA-IND also provides liability protection under the 

 for healthcare providers prescribing, administering, or dispending the drug, and ability for patients to seek compensation if they are seriously injured by the medication through the Countermeasures Injury Compensation Program ( 

). In the largest safety study of 359 healthy adult volunteers, other than local site reactions the most common adverse reactions among those receiving tecovirimat were headache (12%) and nausea (5%) [ 

 . The safety of tecovirimat has not yet been studied in people with 

Tecovirimat may be considered for treatment in people infected with 

TPOXX is available through the Strategic National Stockpile, and LDH has pre-positioned supplies of TPOXX within their Louisiana. All clinicians and care facility pharmacists requesting TPOXX should contact the 

IDEpi clinician 24/7 hotline: 800-256-2748.

TPOXX Expanded Access Investigational New Drug Protocol (

CDC, in partnership with FDA, has made it easier for healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under the EA-IND protocol. The streamlined process reduces the number of required patient treatment forms from six (21 pages) to two (7 pages); decreases patient visits to three visits that can all be conducted via telemedicine; and makes collecting blood, lesion samples, and lesion photos optional. Additional information about the EA-IND protocol for TPOXX can be found 

It is important to note that clinicians can start the patient’s treatment upon obtaining informed consent. All forms can be completed and submitted after treatment initiation to facilitate timely care of the patient. Timely return of patient intake and clinical outcome forms by providers and healthcare facilities enables CDC to monitor clinically appropriate and safe use of TPOXX.

Information for Providers on Jynneos Vaccine

The FDA has licensed JYNNEOSTM (also known by the brand names Imvamune and Imvanex), a replication-deficient smallpox vaccine, for the prevention of smallpox and monkeypox. JYNNEOSTM is an attenuated live virus vaccine. As a replication-deficient vaccine, it can be used for vaccination of people 18 years and older with certain immune deficiencies or conditions, such as HIV or atopic dermatitis. JYNNEOSTM has been studied in people with HIV and atopic dermatitis and no severe adverse events were identified.

LDH has ordered all available JYNNEOSTM doses that have been allocated to Louisiana by CDC. These vaccines are being distributed to regional offices of public health and a limited number of partner providers. Because doses remain in limited supply, LDH is prioritizing JYNNEOSTM vaccine for 2 purposes:

Individuals who are eligible for PEP are identified by LDH epidemiologists during case investigation. These individuals will be contacted by public health staff and referred to parish health units for PEP vaccination.

The supply of vaccine allocated to LDH is not abundant enough to immediately vaccinate all those who may benefit from vaccination with JYNNEOSTM. As a result, PEP++ vaccine doses will be prioritized according to the greatest risk for exposure. Eligibility groups will expand as the vaccine increases. At this time, the following groups are eligible for PEP++ vaccine in Louisiana:

Locations that are administering PEP++ vaccines (based on availability) can be found 

Update for Clinicians on Monkeypox in People with HIV, Children and Adolescents, and People who are Pregnant or Breastfeeding

CDC recently issued clinical considerations for monkeypox infection in multiple populations including: 

. These newly released clinical considerations complement existing clinical guidance for managing monkeypox and provide information on signs and symptoms of 

 infection; pre- and post-exposure prophylaxis; treatment; and infection control in these populations. The update CDC released through the health alert network can be found 

†Testing at public health laboratories remains free. Commercial laboratory companies will bill private insurance, Medicaid or Medicare for all testing performed. Those who are underinsured or uninsured will receive a bill for that testing. The Administration continues to work to identify funding that would cover the cost of monkeypox testing regardless of the individual’s coverage. Clinicians may find the relevant CPT code for Monkeypox virus testing on each commercial laboratory’s website.