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Monkeypox Information For Healthcare Providers

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Organism, Causative agent, Etiologic agent

The infectious agent of monkeypox disease is the monkeypox virus, a species in the genus Orthopoxvirus and the family Poxviridae

Signs and Symptoms

Monkeypox is a severe acute illness, usually with sudden onset of initial symptoms of fever, headache, muscle aches, backache, swollen lymph nodes (lymphadenopathy), chills, and exhaustion. Clinically, the disease closely resembles smallpox, but lymphadenopathy is a more prominent feature in the early stage of monkeypox disease.

Shortly afterwards, a rash develops, usually starting on the face and spreading to other body parts. Lesions typically begin to form simultaneously and evolve together on any part of the body as they progress from small red bumps to larger pus-filled bumps to scabs before falling off. Monkeypox may not always appear the same way and could be clinically confused with a chickenpox or shingles (varicella zoster virus) or a sexually transmitted infection (STI) like syphilis or herpes. The illness typically lasts for 2−4 weeks. If someone has a very weak immune system, then the rash and illness could present differently.

Monkeypox is a serious illness, which can be painful and require hospitalization. In recent years, the case fatality rate has been 3 to 6%, and the number of deaths from monkeypox disease has been higher in young children. 

The incubation period (time from infection to symptoms) for monkeypox is usually 7−14 days but can range from 5−21 days. The rash typically begins within 5 days of the first symptoms.

Therapeutics 

Currently, there is no FDA approved treatment specifically for monkeypox virus infection. However, the CDC holds a non-research Expanded Access Investigational New Drug (EA-IND, also known as compassionate use) protocol that allows TPOXX (tecovirimat) to be used for treatment of monkeypox virus, in adults and pediatric patients. CDC’s guidance on eligibility and treatment considerations can be found at www.cdc.gov/poxvirus/monkeypox/clinicians/Tecovirimat.html.

TPOXX is available as oral capsules and vials for injection. Prescribing information can be found at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214518s000lbl.pdf

To request TPOXX, healthcare providers should make requests for Tecovirimat to their local health department.

Once the health care provider has received TPOXX, they need to complete and report the required forms to the CDC. These forms can be found on the CDC website:

  1. Informed Consent Form,
  2. Patient Intake Form,
  3. FDA Form 1572, and
  4. MedWatch Form (Serious Adverse Event Report).

Testing 

If you are seeking testing for your patients, please check with your hospital lab and usual commercial labs for options. You may also consult with your local health department (https://dshs.texas.gov/idcu/investigation/conditions/contacts/). to request public health testing. More information on public health testing options DSHS Monkeypox Laboratory Testing Guidance for Human Clinical Specimens.

Reporting Requirements

Monkeypox cases are immediately reportable upon suspicion. 

Immediately report persons under investigation, cases of monkeypox, or laboratory reports to your local health department
(https://dshs.texas.gov/idcu/investigation/conditions/contacts/).

Several Texas laws (Tex. Health & Safety Code, Chapters 81, 84, and 87) require specific information regarding notifiable conditions to be provided to the Texas Department of State Health Services (DSHS). Health care providers, hospitals, laboratories, schools, and others are required to report patients who are suspected or confirmed of having a notifiable condition (25 Tex. Admin. Code §97.2).

Frequently Asked Questions for TPOXX and JYNNEOS

FAQs for Tecovirimat (TPOXX)

What is tecovirimat (TPOXX)?
Tecovirimat (TPOXX) is an antiviral medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of human smallpox in adults and children.

There are currently no treatments specifically for monkeypox virus infections. Since monkeypox and smallpox viruses are similar, medications like TPOXX may be used for people with monkeypox infection.

While TPOXX use for monkeypox is not approved by the FDA, the Centers for Disease Control and Prevention (CDC) holds a non-research Expanded Access Investigational New Drug (EA-IND) protocol that allows for the use of TPOXX for treatment of monkeypox, in adults and children of all ages.

Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Cases | Monkeypox | Poxvirus | CDC

What does “Expanded Access for Investigational New Drug” mean?
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Expanded Access | FDA

What documentation is required for TPOXX EA-IND?
The following required documents can be downloaded from the CDC website:  

Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox | Monkeypox | Poxvirus | CDC

Informed
Consent Form
Must obtain informed consent using the CDC’s form PRIOR to Initiation of Treatment.  Return to CDC within seven working days of initiation of therapy by email (regaffairs@cdc.gov) or upload to CDC's secure Share File
Patient
Intake Form
Provide baseline assessment information
FDA Form 1572   One signed 1572 per facility for all TPOXX treatment administered at the same facility.
Serious Adverse Events (MedWatch Form) Report life-threatening or serious adverse events associated with TPOXX by completing a  PDF MedWatch Form (or downloaded from the FDA website). Return to the CDC via email (regaffairs@cdc.gov) or upload to CDC’s Secure Share File within 72 hours of awareness or sooner, if possible.

As a prescribing provider for TPOXX, am I covered by the CDC’s Institutional Review Board (IRB) or do I need to get approval from my hospital or another IRB?
CDC IRB serves as the central IRB for review and approval. Facilities may elect to rely on the CDC IRB for centralized review and approval by submitting a request to the CDC’s Human Research Protection Office within seven calendar days of TPOXX treatment at your facility. CDC will promptly document an agreement in writing using the CDC IRB Authorization Agreement (Sample Template) [4 MB, 2 pages] which must be signed by both parties. Facilities that elect to obtain their own IRB review must ensure compliance with applicable FDA regulations related to the TPOXX EA-IND protocol. Note that the posted TPOXX EA-IND protocol and the attachments must be used without any changes being made by the IRB.

Since this TPOXX EA-IND protocol is solely for treatment use, CDC determined that its use does not constitute research involving human subjects as defined by 45 CFR 46.102, therefore, the federal-wide assurance requirements do not apply.

Healthcare providers may want to check with their own IRB to determine if organizational policy requires additional approval.

Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox | Monkeypox | Poxvirus | CDC

What are the available formulations for TPOXX?
TPOXX is available in two forms: a capsule (200 mg) and injection for intravenous (IV) administration.  

Where can I find the dosage and administration information for TPOXX?
Dosage and administration information can be found in the Expanded Access Investigational New Drug Protocol: Use of Tecovirimat (TPOXX) for Treatment of Human Non-Variola Orthopoxvirus Infection in Adults and Children.

Tecovirimat-IND-Protocol-CDC-IRB.pdf

Instructions for Opening and Mixing Tecovirimat Capsules with Food for Those Who Cannot Swallow Pills, Especially Infants and Children (cdc.gov)

How do I obtain TPOXX?
Due to limited supply of TPOXX, orders must be tied to individual patient treatment (i.e., no batch or bulk orders).

To request TPOXX, healthcare providers should contact their local health department.

TPOXX is available as capsules and vials for injection. Prescribing information can be found at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214518s000lbl.pdf

Once the healthcare provider has received TPOXX, they need to complete and submit the required forms (listed below) to the CDC. These forms can be found on the CDC website:

  1. Informed Consent Form which must be completed prior to treatment initiation,
  2. Patient Intake Form,
  3. FDA Form 1572, and
  4. MedWatch Form (Serious Adverse Event Report).

Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox | Monkeypox | Poxvirus | CDC

FAQs for JYNNEOS Vaccine

What is JYNNEOS?
JYNNEOS is a vaccine that is approved by the FDA and indicated for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

JYNNEOS vaccine is licensed as a series of two doses administered 28 days (4 weeks) apart via a standard regimen of subcutaneous administration (0.5 ml/dose).

CDC recommends getting the second dose on time; however, if there is a delay for any reason, get it as soon as possible, preferably within 35 days after the first dose.

An individual is considered fully vaccinated against monkeypox 14 days after receiving the second dose.

JYNNOES Prescribing Information

JYNNOES Emergency Use Authorization
On August 9, 2022, the FDA issued an emergency use authorization (EUA) allowing an alternative regimen, which involves an intradermal (ID) route of administration with an injected volume of 0.1mL (five doses per vial) for individuals 18 years and older who do not have a history of developing keloid scars. This dose-sparing approach could increase the number of available JYNNEOS vaccine doses by up to five-fold.

The EUA also allows the standard regimen (0.5mL/dose) for individuals under 18 years of age.

For individuals who have a history of developing keloid scars, the vaccine must be administered via subcutaneous route (0.5 mL/dose) regardless of age. Fact Sheet For Healthcare Providers Administering JYNNEOS: EUA

What does Emergency Use Authorization Mean?
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

Emergency Use Authorization for Vaccines Explained | FDA

How is JYNNEOS vaccine administered?
Under the EUA, for individuals 18 years and older with no history of developing a keloid scars, the vaccine is administered using  an alternative regimen, an intradermal (ID) route of administration with an injected volume of 0.1mL per dose (five doses per vial).

For individuals under 18 years of age, the vaccine is administered using the standard regimen of subcutaneous route (0.5 mL/dose).

For individuals who have a history of developing keloid scars, the vaccine is administered using subcutaneous route (0.5 mL/dose) regardless of age.

JYNNEOS Preparation and Administration: Standard Regimen
JYNNEOS Preparation and Administration: Alternative Regimen
JYNNEOS Provider Agreement

Is the alternate route (intradermal administration) of vaccination effective?
Results from a clinical study showed that the lower intradermal dose was non-inferior to the standard subcutaneous dose. This study supported the authorization of the alternative dosing regimen for individuals 18 years and older.

Comparison of vaccine formulations subcutaneous versus intradermal

Can JYNNEOS be administered with other vaccines?
CDC recommends that in most cases, a JYNNEOS vaccine can be administered at the same time as other vaccination. However, there are additional considerations for administering COVID-19 vaccines. , except possibly COVID-19 vaccine.

  • 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 orthopoxvirus vaccination (either JYNNEOS or ACAM2000) before receiving a Moderna, Novavax, or Pfizer-BioNTech COVID-19 vaccine, because of the observed risk for myocarditis and/or pericarditis after receipt of ACAM2000 orthopoxvirus vaccine and mRNA (i.e., Moderna and Pfizer-BioNTech) and Novavax COVID-19 vaccines and the unknown risk for myocarditis and/or pericarditis after JYNNEOS.

Interim Clinical Considerations for Use of COVID-19 Vaccines

How is JYNNEOS supplied?
JYNNEOS is supplied in a package of 20 vials. Each vial contains 0.5mL.

Package of 20 vials (Package NDC number: 50632-001-2; Vial NDC number: 50632-001-1)

Who is eligible to receive JYNNEOS?
People with a known or possible exposure (post-exposure prophylaxis PEP and close contact of an individual confirmed to have monkeypox PEP++) to the Monkeypox virus remain the highest priority for vaccination. Local health entities may also expand vaccination to include pre-exposure prophylaxis (PrEP) for people who are at an increased risk of Monkeypox, such as people 18 years of age and older who:

  • are men who have sex with men, and
  • have had multiple or anonymous sex partners within the previous 21 days.

The Texas Department of State Health Services (DSHS) further recommends prioritizing eligible people who:

  • have a sex partner who is showing symptoms of monkeypox, such as a rash or sores;
  • have had a diagnosis of HIV, chlamydia, gonorrhea, or early syphilis, within the previous 12 months;
  • are on HIV pre-exposure prophylaxis; or
  • have a condition that may increase their risk for severe disease if infected with monkeypox virus, such as HIV, atopic dermatitis, or eczema.

Local health entities should consider the outbreak in their communities, the number of doses on hand, and the timing of future deliveries as they determine whether and how to implement PrEP. As you do so, please

  • Ensure to maximize doses available by using the newly authorized 5 doses/per vial intradermal administration (0.1 mL/dose).
  • account for second doses within the current allocation,
  • hold some doses specifically for post-exposure prophylaxis and outbreak response.

Monkeypox Info | Home page (texas.gov)

Who should not receive JYNNEOS vaccine?
People who are moderately or severely ill should usually wait until they have recovered to their baseline state of health before vaccination.

CDC considers vaccination with JYNNEOS to be contraindicated (not recommended) in the following situations:

  • History of severe allergic reaction (e.g., anaphylaxis) after a previous dose of JYNNEOS

JYNNEOS Vaccine | Monkeypox | Poxvirus | CDC

How do I order JYNNEOS?
In the current outbreak situation, all vaccine requests start with the local health departments. Due to the limited supply of JYNNEOS vaccine, are to be routed through the local health departments and DSHS public health regions, at this time. 

Local health departments(LHD) and DSHS public health regions (PHR) can transfer vaccine doses to providers currently enrolled in the Texas Vaccines for Children (TVFC), Adult Safety Net (ASN) or COVID programs by submitting a transfer request through the Vaccine Allocation and Ordering System (VAOS).

For JYNNEOS vaccine transfers to providers not enrolled in TVFC, ASN, or COVID, and do not have a PIN on VAOS, please complete the Monkeypox Transfer Form to document the transfer and send the completed form to DSHSMPXVax@dshs.texas.gov.

Guidance for locating LHDs and DSHS PHRs in your area:
Texas Local Public Health Organizations - A listing of Local Health Departments, Public Health Districts and Local Health Units in Texas. For information or questions, contact RLHO at DSHS LHD Team.

DSHS Public Health Regions - A listing of the DSHS Public Health Regions that includes headquarter locations, Regional Medical Directors and Deputy Directors, and links to their webpages.

Please feel free to contact with any additional information or questions you might have at 512-776-7770, or email at DSHS LHD Team.

Are there any reporting requirements for JYNNEOS vaccine?
Reporting doses administered into Vaccine Allocation and Ordering System (VAOS) should be conducted within 24 hours of vaccination.  It is also strongly encouraged to receive patient consent for reporting doses into Immunization Information System (IIS), ImmTrac2, for accurate reporting doses administered. The ImmTrac2 consent form may be found at: 

https://www.dshs.texas.gov/immunize/immtrac/docs/F11-12956.pdf

Vaccination providers who are administering JYNNEOS under the EUA are required to report the following adverse events that occur after JYNNEOS vaccination:

  • Vaccine administration errors whether or not associated with an adverse event
  • Serious adverse events (irrespective of attribution to vaccination)
  • Cases of cardiac events including myocarditis and pericarditis
  • Cases of thromboembolic events and neurovascular events

Information on how to submit a report to VAERS is available at https://vaers.hhs.gov or by calling 1-800-822-7967.

Is there any required documentation needed for JYNNEOS vaccine?
A JYNNEOS vaccine information statement (VIS) or FDA JYNNEOS EUA Fact Sheet, as applicable.

Is there any recommended patient counseling?
Recipients should be informed of the risks and benefits of JYNNEOS prior to vaccination. Healthcare providers should ascertain the medical history of recipients to appropriately determine the route of vaccine administration. Recipients should be counseled about possible side effects from vaccination including injection site pain, redness, swelling, sclerosis, itching, fatigue, headache, nausea, chills, and muscle aches. There have been reports of prolonged duration of induration or erythema following intradermal administration. Side effects usually self-resolve.

Additional Resources

Last updated September 20, 2022