Monkeypox Situation Report #6

August 25, 2022  

High-Level Situation Overview  

Green text indicates new or updated content in this assessment compared to the previous week. This sitrep contains current most vital information to inform healthcare and public health sector stakeholders and the public. For supplemental information, please refer to our earlier reports, which can be found on this site.

United States News

• In the US, cases are highest in New York. As of August 24, there are 16,603 confirmed monkeypox/orthopoxvirus cases in the US. The virus has spread to all 50 states as well as Puerto Rico.  

• New York, California, and Illinois have declared public health emergencies in response to an increase in monkeypox cases. Missouri’s Department of Health and Senior Services passed an emergency rule amendment to be able to access resources to monitor and counter the viral spread. Certain cities declared a public health emergency as well. Some examples are Austin and Dallas in Texas, San Francisco, Pasadena and Sacramento in California, and King County in Washington. (08/23/2022) 

• To accelerate the delivery of JYNNEOS vaccines, HHS has facilitated an agreement between Bavarian Nordic and Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, Michigan. This agreement establishes the first US fill and finish line for the JYNNEOS vaccine. The US ordered 5.5 million vials of JYNNEOS from Bavarian Nordic and this deal allows for 2.5 million of those vials to be filled and finished by GRAM. (08/18/2022) 

• The US Department of Health and Human Services (HHS) launched a pilot program focused on bringing vaccination and testing to large events that appeal to the LGBTQI+ population, specifically men who have sex with men (MSM), in the coming weeks. HHS is setting aside 50,000 supplemental doses of vaccine to be deployed from Strategic National Stockpile (SNS). Jurisdictions may request these doses based on the event size, the event nature, and the ability to reach the at-risk groups. HHS is offering assistance and support for these events, including developing vaccine and testing strategies; and developing tools for information gathering from event participants. HHS is already working on events in NC, GA, and LA. HHS allocated 2,000 doses to Charlotte Pride activities this past weekend (August 20-21) to replenish 18,000 doses North Carolina already received through the allocation. 

• To extend the supply of JYNNEOS vaccines, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) that allows healthcare providers to administer JYNNEOS vaccines intradermally (ID). This alternate vaccination route uses one-fifth of the regular dose to inject the vaccine into the dermis, a layer of skin below the top skin layer or epidermis, to produce an equal immunological response. Employing a different injection technique will increase the availability of the vaccine, allowing more at-risk individuals to get vaccinated against monkeypox. The CDC released a short video on how to administer the JYNNEOS vaccine intradermally. Additional guidance may be found on the CDC website.  (08/09/2022) 

• HHS declared the monkeypox outbreak a Public Health Emergency (PHE). (08/04/2022). 

• Hospital capacity is not presently at risk as hospitalizations have been low. Treatment includes isolation and pain management, often at home, reducing the burden on personal protective equipment (PPE) in healthcare settings. 

Disease Transmission 

• The virus spreads primarily through direct skin-to-skin or indirect close contact with someone who has monkeypox. Direct contact with monkeypox lesions is a primary mode of transmission, though spread may be facilitated through respiratory and bodily secretions such as sweat, and through contact with contaminated material such as clothing or linens. 

• In the past, monkeypox has had an R0 of just under one. The R0 of any infectious disease is the number of people whom a single infected person can transmit the disease to. As more data is emerging with the current monkeypox outbreak, there are some indications that the R0 might be closer to 2.

Assessment on Healthcare Supply Chain Needs for Treatment and Prevention

Vaccines   

• There are two FDA-authorized vaccines to protect against monkeypox: JYNNEOS and ACAM2000.  
  • The JYNNEOS is a two-dose vaccine that is FDA-approved for the prevention of smallpox and monkeypox. It is manufactured by Bavarian Nordic in Kvistgaard, Denmark.  
    • The Biden-Harris Administration announced that they would “stretch out” the limited supply of the JYNNEOS vaccine by using a different method of injection. Intradermal (ID), aka Mantoux injection, induces a higher immune response as the dermis has a higher concentration of antigen-presenting cells, specifically dendritic cells, that have the ability to replicate antigens and link other immune cells to the vaccine adaptive immune cells. , that have the ability to replicate antigens and link other immune cells to the vaccine's adaptive immune cells. (08/09/2022) 
      • The CDC has issued intradermal vaccine administration guidance for clinicians detailing administration tips and considerations.   
      • Individuals who received their first vaccine dose subcutaneously may receive a second dose with the alternative method, intradermally, to complete their vaccination series.  
      • Guidance currently recommends that people 18 and under and the immunocompromised be given a subcutaneous injection. Those 18 and older without immunocompromising conditions are recommended to receive ID injection.   
    • The vaccine may be utilized as pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP).
      • The vaccine must be administered within 4 days of exposure to provide the best chance of preventing the onset of symptoms. (07/26/2022)  
      • A vaccine administered between 4-14 days of exposure may only lessen the severity of the symptoms and not prevent the disease. so healthcare professionals may recommend vaccines for those who have had close contact with a person who is infected. (06/14/2022) 
    • HHS announced that it had accelerated the delivery of an additional 150,000 doses in September, originally slated to arrive in November.  (08/04/2022)  
    • FDA gave supplemental approval to the biologics license for the JYNNEOS vaccine, enabling 786,000 more doses to become available for use in the US (07/27/2022). 
    • BARDA has ordered an additional 2.5 million doses of the frozen liquid vaccine, with deliveries anticipated to begin at the end of 2022 and continue onto 2023.  Five million additional vaccine doses have been ordered by BARDA since the start of the outbreak.  (07/01/2022) 
    • The CDC recommends the JYNNEOS vaccine as an alternative to ACAM2000 and prescribes its use for primary vaccination and booster doses due to its effectiveness and less severe side effects. ACAM2000 is not recommended for individuals who are severely immunocompromised or have impaired skin barrier (06/02/2022). 
  • ACAM2000, a single-dose vaccine, manufactured by Emergent Product Development Gaithersburg, Inc., is FDA-approved for the prevention and immunization against smallpox. Correction: We previously reported that ACAM2000 is manufactured by Sanofi, however, Emergent acquired ACAM2000 in 2017 at which point Emergent assumed responsibilities for manufacturing of ACAM2000. (Corrected 08/25/2022)
  • ACAM2000 is “allowed for use against monkeypox under an Expanded Access Investigational New Drug (EA-IND) Application, which requires informed consent along with submission of additional forms.”  
    • The US has over 100 million units of ACAM2000 in the Strategic National Supply (SNS).  (07/01/2022) 

Vaccine Allocation 

• ASPR has shipped 1,061,913 of JYNNEOS vaccine, and developed a tracker showcasing the total doses allocated, requested, and shipped by state jurisdiction. (08/19/2022) 
• The current allocation model for JYNNEOS is 75% case burden and 25% at-risk allocation to better respond to communities experiencing greater impacts. This allocation strategy will continue to adapt with each phase of vaccine allocation and distribution.  
• At this time, all vaccine distribution is routed through the SNS. An alternative vaccine distribution system popularized by the COVID-19 response, VTrckS (Vaccine Tracking System), is not currently being used.  
• Phase 3 of the National Vaccine Strategy (NVS) distribution dates are July 29, August 15, and towards the end of August. The new immunization strategy using an intradermal injection increases the number of doses to the public. (08/15/2022) 
• HHS opened the ordering of doses under Phase 4 of the NVS on August 22. Additional information on the structure of Phase 4 will be provided at a later date. (08/19/2022)   

Needles and Syringes   

• There are no current reported concerns related to needles and syringe supply that could impact vaccine administration.  
• JYNNEOS uses a standard needle and syringe for subcutaneous injection and a tuberculin syringe for intradermal injection.   
  • Subcutaneous administration  
    • Vaccine dosage is 0.5 mL  
    • Syringe size: 5/8” and 23-25 gauge  
  • Intradermal (ID) injection  
    • Vaccine dosage is 0.1 mL  
    • Tuberculin syringe with a 27-gauge 1/4 to 1/2” needle with a short bevel. (08/11/2022) 
    • The CDC released a short video demonstrating how to administer the JYNNEOS vaccine intradermally.  (08/10/2022) 
• ACAM2000 requires bifurcated needles for injection.  
  • 1mL syringe with 25-gauge x 5/8” needle which is provided in the Emergent vaccine kit. 

• CDC is reporting Non-Variola Orthopoxvirus and Monkeypox Virus Laboratory Testing Data from Laboratory Response Network laboratories and 4 commercial laboratories using the CDC non-variola orthopox assay and one commercial laboratory using a non-variola orthopox and monkeypox multiplex assay. Three metrics are available: total specimens tested, cumulative positivity rate, and capacity available.  
• Five (5) commercial laboratory companies, in addition to public health laboratories, are conducting orthopoxvirus testing, doubling nationwide testing capacity. (06/22/2022) 
• Orthopoxvirus tests that detect orthopox DNA via polymerase chain reaction (PCR) are used to confirm monkeypox cases. (07/05/2022) 
• Tests involve swabbing the site of lesions “with a sterile dry polyester, rayon or Dacron swab” and taking a second swab from the same lesion. Both swabs are collected in an aliquot tube without any transport media.  
  • Guidelines for the preparation and collection of specimens have been issued by the CDC for testing personnel. (07/29/2022) 
• Blood tests are not viable at this time due to the minimal efficacy of detection and correlation with the clinical course of infection. (06/14/2022) 
• The Biden Harris Administration response plan includes growing testing capacity to more than 70 labs in 48 states. (06/28/2022) 
• CDC released test procedures for the monkeypox virus and generic real-time PCR tests.

• There are no targeted treatments for monkeypox, but antivirals for smallpox may be used due to genetic similarities between viruses. Tecovirimat (TPOXX) antiviral may be prescribed to patients that are at higher risk of becoming ill, such as those with weakened immune systems.  (08/10/2022) 
  • TPOXX is FDA-approved for the treatment of smallpox disease in adults and children is not FDA-approved for the treatment of monkeypox. However, CDC holds a “non-research expanded access Investigational New Drug (EA-IND) protocol that allows for the use of tecovirimat for primary or early empiric treatment of non-variola orthopoxvirus infections, including monkeypox, in adults and children of all ages.” (08/03/2022)  
  • The CDC has simplified the process that healthcare providers use to request TPOXX. The patient may begin treatment following the provider’s submission of the forms and documents required for obtaining TPOXX, and their delivery from the SNS. Patients are now given the option to see their doctor virtually to request the medication (08/18/2022)  
  • Requirements for photographing lesions, collecting specimens, and shipping them to the CDC are now optional. TPOXX can be administered as soon as healthcare providers receive informed consent from the patient.  (08/08/2022)  
  • SIGA Technologies, Inc., the manufacturer of TPOXX, announced the exercise of procurement options under an existing contract with HHS’s BARDA for the delivery to the US government of intravenous (IV) formulation of TPOXX treatment courses. The ordered treatment courses are valued at approximately $26 million. Product deliveries of IV TPOXX related to this contract option are “targeted for 2023.” (08/09/2022) 
  • SIGA Technologies has developed a TPOXX factsheet with information on the drug and its development.    

• CDC has started reporting demographics of patients receiving TPOXX for treatment of monkeypox. As of August 18, CDC has “received and abstracted data from forms submitted on 288 patients.” CDC states that “the number underestimates the number of patients receiving TPOXX treatment as healthcare providers can start treatment before submitting paperwork to CDC." (8/24/2022)  
• The SNS is currently supplying the treatments available for monkeypox. These products do not have an expiration date on the label. ASPR has released an outline of the products currently circulating and their expiration dates to address this. (08/08/2022)   
• The SNS has more than 1.7 million courses of TPOXX that are available to states and territories for free. (07/21/2022) 
  • ASPR is making 50k TPOXX patient courses available to jurisdictions for prepositioning. 
  • This allocation is on top of the 20,000 TPOXX patient courses ASPR has deployed to jurisdictions from SNS. 

Considerations for Provider Institutions  

• The CDC posted revised guidelines that are intended to help streamline the health care response process. These guidelines permit physicians and healthcare providers to act on a course of treatment with reduced paperwork, patient samples, etc., to expedite the reaction to new monkeypox infections. (08/18/2022) 
• Frequently asked questions from clinicians are periodically being updated with answers on the CDC Clinician FAQ page.  (08/11/2022) 
• Patients in healthcare settings should isolate themselves in their room, with the door closed, if safe to do so. Special air ventilation is not required. (08/11/2022)  
• The CDC has released guidance for infection control in healthcare settings. (08/11/2022) 
• PPE in Healthcare Settings  
  • The CDC recommends that healthcare professionals use gowns, gloves, eye protection, and National Institute for Occupational Safety & Health (NIOSH) approved respirators with N95 filters or higher. (08/11/2022) 
• JYNNEOS storage and handling summary  

Vulnerabilities   

• The CDC updated guidance on providing care to children and adolescents younger than 18. Previous evidence from patients infected with Clade I, formerly known as the Congo Basin clade, showed an increased risk of severity in children under 8 years of age. However, the 2022 Multinational Monkeypox Outbreak is caused by Clade II, formerly known as the West African clade, which is typically less severe in children than Clade I. The 2022 monkeypox outbreak strain has been renamed Clade IIb, as announced by the WHO. (08/22/2022)  
• CDC and other public health and healthcare actors should work to reduce stigma around monkeypox by prioritizing strategies and producing resources based on a lens of equity. (07/12/2022) A health equity lens is critical to achieving the best possible health outcomes. The ongoing public health response to this monkeypox emergency must include health equity. Several comprehensive approaches to uplifting health equity as a focus of current public health response, include:   
• Framing communication to provide information on prevention practices for ALL people. Phase 3 and 4 of the national monkeypox vaccination effort are expected to expand vaccine availability and eligibility criteria to include people of any sexual orientation and gender identity who are at greater risk of exposure.  
• Tailoring messaging and educational material for different communities and developing evidence-based recommendations and guidelines.  
• Ensuring the public health organizations inform their constituents that all demographics are   susceptible to monkeypox. The purpose of amplifying this information is not to create panic, but to instill awareness and preventative diligence while battling the misinformation that the virus is confined exclusively within LGBTQI+ community, more specifically MSM.  
• Because different geographies have different variants circulating, the majority of cases in Africa are being observed in adolescents of 15 years. Outside of Africa, most cases are being observed in MSMs. (05/27/2022) 
• The WHO has released a factsheet on monkeypox and the most vulnerable communities. They include healthcare providers, immunocompromised individuals, and men who have sex with other men (MSM). (05/19/2022) 

Federal Government Response Posture

• The Biden Administration designated FEMA’s Robert Fenton and CDC’s Demetre Daskalakis as the National Monkeypox Response Coordinators to coordinate all White House and Federal agency monkeypox activities. (07/25/2022) 
• Response pillars:  
  • Scale up production of vaccine procurement, production, and distribution to conduct widespread immunization of public.  
  • Expand access to testing to detect and control spread.   
  • Expand access to treatments.   
  • Conduct widespread outreach to communities most affected by the virus.  

Global News

• The World Health Organization (WHO) declared Monkeypox Outbreak a Public Health Emergency of International Concern (PHEIC). (07/23/2022)  

• The WHO members have renamed the variants to reduce and avoid stigmatization of regions and countries, therefore inadvertently of their inhabitants, whose names they previously contained. The variants are now denoted by “Clade” followed by roman numerals and a lower-case letter (e.g., Clade IIb). (08/12/2022)  

• The renaming of monkeypox has been opened to public submission by WHO members. Those interested in submitting a name may do so through the submission portal under ICD-11.   

• Monkeypox cases continue to increase and spread across the globe in countries that typically do not experience monkeypox outbreaks. Globally there have been more than 44,000 confirmed cases this year, with Spain, the United Kingdom, the US, and Germany, experiencing the greatest number of cases. (08/23/2022) 

• Countries in which monkeypox is non-endemic are creating global vaccine inequities by mass purchasing supplies, such as vaccines, and is impeding response in countries in which monkeypox is typically endemic and where the virus has recently been exhibiting novel features and clinical presentation.