Monkeypox Situation Report #4

High-Level Situation Overview

1. JYNNEOS Vaccine Distribution displays the number of vaccines requested by and allocated to each state.
2. Reported Cases displays the number of reported cases of monkeypox present per state.
3. Emergency Declarations displays Public Health Emergencies present per state across the country.

Assessment on Healthcare Supply Chain Needs for Treatment and Prevention

Vaccines

• There are two FDA-authorized vaccines to protect against monkeypox: JYNNEOS and ACAM2000.
  • FDA gave a supplemental approval to the biologics license for the JYNNEOS vaccine on July 27, 2022. This entailed an expedited inspection and approval process of Bavarian Nordic's fill-and-finish capabilities that enabled 786,000 more doses to become available for use in the U.S.
  • The CDC recommends the JYNNEOS vaccine over ACAM2000 due to effectiveness and less severe side effects. ACAM2000 is not recommended for severely immunocompromised individuals.
• 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 vaccine available in the Strategic National Stockpile (SNS) is freeze dried and requires cold chain storage at -13°F to +5°F. Once thawed, it needs to be kept between 36°F and 46°F for 12 hours. These conditions may be prohibitive for countries that have limited vaccine storage infrastructure.
  • As of July 1, BARDA has ordered an additional 2.5 million doses of the liquid frozen vaccine, with deliveries anticipated to begin at the end of 2022 and continuing onto 2023. As of July 22, ASPR has delivered 310,385 doses. Five million additional vaccine doses have been ordered by BARDA since the start of the outbreak and deliveries are expected to continue through mid-2023.
  • HHS announced that it has accelerated the delivery of an additional 150,000 doses to arrive in September, originally slated to arrive in November.
  • Bavarian Nordic has expected capacity to produce 30 million doses of vaccine annually. The vaccine company has recently announced that they will increase manufacturing hours and create more night shift options to increase production above the 30 million doses in order to meet global demands.
  • As of August 10, ASPR has delivered 634,213 doses. ASPR has developed a tracker showcasing the total doses allocated, requested, and shipped by state jurisdiction.
  • On August 9, the Biden-Harris Administration announced that they will “stretch out” the limited supply of monkeypox vaccines 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 vaccines adaptive immune cells.
  • When necessary, alternative methods of vaccination can be administered to complete the two-dose course (i.e., subcutaneous injection and intradermal injection).
• ACAM2000, a single dose vaccine, is manufactured by Sanofi Pasteur Biologics and is FDA-approved for prevention and immunization against Smallpox. ACAM2000 is “allowed for use against monkeypox under an Expanded Access Investigational New Drug (IND) Application, which requires informed consent along with submission of additional forms.”
  • Sanofi has several manufacturing footprints throughout the world including in France, Canada, and Singapore. It is unclear where ACAM2000 is manufactured.
  • The US has over 100 million units in the SNS. The CDC is also recommending the JYNNEOS vaccine over ACAM2000 due to effectiveness and less severe side effects. ACAM2000 is not recommended for severely immunocompromised individuals.
  • It is stored in powder form in cold storage and reconstituted with a diluent. ACAM2000 should be stored in a freezer with an average temperature of -15°C to -25°C (+5°F to -13°F). Prior to reconstitution, ACAM2000 vaccine retains a potency of 1.0x108 PFU or higher per dose for at least 18 months when stored at refrigerated temperatures of +2 to 8°C (36 to 46°F). After reconstitution, ACAM2000 vaccine may be administered during a 6 to 8 hour workday at room temperature (20-25°C, 68-77°F). Reconstituted ACAM2000 vaccine may be stored in a refrigerator (2-8°C, 36-46°F) no longer than 30 days, after which it should be discarded.
• There is limited supply of JYNNEOS vaccine, which does not currently meet demand. HHS is using evolving case burden and at-risk population size to determine allocation strategy of the limited vaccine supply.
  • At first, the allocation formula was based on 50% case burden and 50% at-risk model.
  • As of July 21, the formula was adjusted to be more reflective of case burden. The current model is 75% case burden and 25% at-risk allocation in order to better respond to communities experiencing greater impacts. This allocation strategy will continue to adapt with each phase of vaccine allocation and distribution and HHS will continue to adapt the allocation strategy if needed.
  • Per a June 28 HHS announcement, "JYNNEOS vaccine will be allocated using a four-tier distribution strategy that prioritizes jurisdictions with the highest case rates of monkeypox. Within each tier, doses of JYNNEOS will be allocated based on the number of individuals at risk for monkeypox who also have pre-existing conditions, like HIV."
• At this time, all vaccine distribution is being done through the SNS. An alternative vaccine distribution system popularized by the COVID-19 response, VTrckS (Vaccine Tracking System) is not currently being used.

Needles and Syringes

• There are no current reported concerns related to needles and syringe supply associated with vaccines.
• JYNNEOS uses standard needle and syringe for injection (sub-cutaneous administration).
  • Sub-cutaneous administration
    • Vaccine dosage is 0.5 mL
    • Syringe and needle size not disclosed in package insert
  • Intradermal (ID) injection
    • Vaccine dosage is 0.1 mL
    • A tuberculin type needle is used for ID injection. Gauge and needle size has not been disclosed.
• ACAM2000 requires bifurcated needles for injection.
  • 1mL syringe with 25 gauge x 5/8” needle which is provided in the Sanofi vaccine kit.

Testing

• To meet the increasing demand for orthopox virus testing, HHS is expanding testing capacity beyond public health labs to include five (5) commercial laboratory companies, doubling nationwide testing capacity.
• The Laboratory Response Network (LRN) announced that the week of July 18, it was able to test 24,000 specimens. As of July 21, the nation’s overall testing capacity has increased from 6,000 specimens to 80,000 specimens per week with augmented capacity from commercial labs.
  • Both LabCorp and Mayo Clinic Laboratories expect to be able to perform up to 10,000 tests per week. Other commercial labs that will offer testing include: Aegis Science, Quest Diagnostics, Sonic Healthcare.
  • On July 25, New York State announced that the New York State Department of Health approved Quest Diagnostics' application for testing to identify monkeypox in the state. This should further increase testing capacity in the state, with deployment expected "in the weeks ahead."
• Orthopox virus tests that detect orthopox DNA via polymerase chain reaction (PCR) are used to confirm monkeypox cases.
• 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.
  • Slightly modified testing guidelines have been updated by CDC as of July 29, 2022. Swabbing 2-3 lesions should be sufficient, and two swabs from each lesion should be collected, preferably from different locations on the body or from lesions which differ in appearance.
  • If transport media used, only viral transport media (VTM) is accepted at this time by CDC.
• The Biden Harris Administration response plan includes growing testing capacity to more than 70 labs in 48 states.
• No shortages related to the test supplies are currently reported.
• Tests results are delivered with 2-3 days.
• CDC released test procedures for monkeypox virus and generic real-time PCR tests.

Treatments

• There are no targeted treatments for monkeypox, but being genetically similar to Smallpox, antivirals may be used.
  • Tecovirimat (TPOXX) antiviral may be prescribed to patients that are at higher risk of becoming ill, such as those with weakened immune systems.
    • TPOXX is FDA-approved for the treatment of smallpox disease in adults and children. It 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.”
    • The SNS has more than 1.7 million courses of TPOXX and will be made available to states and territories for free.
    • The CDC has simplified the process that healthcare providers use to request TPOXX. The forms and documents required for obtaining TPOXX can be submitted following the patient beginning treatment.
    • 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.
  • Vaccines, including JYNNEOS, when given early enough after exposure, may lessen the severity of the disease so healthcare professionals may recommend vaccines for those who have had close contact with a person who is infected.
    • To provide the best chance of preventing the onset of symptoms, vaccines must be administered within 4 days of exposure. Vaccines administered between 4-14 days of the exposure may only reduce symptoms and not prevent the disease.
• Patients in healthcare settings should be isolated in their own room, with the door closed, if safe to do so. Special air ventilation is not required.
• 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.

Considerations for Medical Professionals

• The CDC has released guidance for infection control in healthcare settings.
• The CDC posted revised guidelines on July 22 that are intended to help streamline the health care response process. These new guidelines permit physicians and healthcare providers to act on a course of treatment with reduced paperwork, patient samples, etc., in order to expedite the reaction to new monkeypox infections.

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.
• Gloves – Sixty percent of global supply of gloves is produced in Malaysia which has experienced a reduction in manufacturing capacity causing a sustained, global nitrile glove shortage. COVID cases are still impacting manufacturing capacity as it has curbed the migrant workforce in Malaysia. However, supply seems to have mostly stabilized.
• Presently, there are no significant shortages for either raw materials for PPE or PPE itself. However, as much of the world’s PPE is manufactured in China, there is a risk of shortages and/or logistical delays due to the zero-COVID policy which has caused supply chain disruptions in the past. There have not been significant cases of monkeypox reported in China, but should they begin to increase, it may be assumed that China will likely implement a similar approach as they did to COVID. 

Vulnerabilities

• The WHO has released a factsheet on monkeypox and the communities that are most vulnerable. They include Healthcare providers, Immunocompromised individuals, and men who have sex with other men (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.
• There should be a focus on combatting communication challenges, lack of access for tests, lack of available vaccines, and stigma.
• As learned from the past three years of responses, factors that will contribute to the success of the response to this outbreak will depend on local, state, and regional response strategy (i.e., management) of scarce or limited resources. Ensuring that supplies for vaccines, testing, and treatment will be available in sufficient quantities to contain the outbreak will require a thoughtful and coordinated approach to ensure that communities at highest risk are appropriately prioritized.
• CDC and other public health and healthcare actors should work to reduce stigma around monkeypox by prioritizing strategies and producing resources based in a lens of equity. Employing a health equity lens is critical to achieve best possible health outcomes. The ongoing public health response to this monkeypox emergency must include health equity. There are several key ways to uplift health equity as a focus of this public health response, including:
  • It is important to frame communication to provide information on prevention practices for all people.
  • Create messaging and educational material that is tailored for different communities and developed with evidence-based recommendations and guidelines.
  • Ensure public health community informs that all populations can be susceptible to monkeypox. This is not to create panic, but to instill awareness and diligence that the virus is not confined exclusively within MSM.
• The CDC has recently released guidance on providing care to children and adolescents younger than 18 years of age. Previous evidence from patients infected with 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 the West African clade of the virus, which is typically less severe in children than the Congo Basin clade.

• Secretary Becerra discussed the response plan and distribution of the over 1.1 million vaccine doses available in the country by HHS. He also summarized the declaration of public health emergency released last week.
• Dr. Callif, FDA Commissioner, discussed the FDA’s issuance of the Emergency Use Authorization allowing for intradermal administration of the JYNNEOS vaccine.
  • The EUA also allows for use of the vaccine in individuals younger than 18 years old, determined to be at high risk of monkeypox infection.
• Dr. Walensky, Director of CDC, announced the launch of a robust outreach training and education plan CDC is starting today to support a transition to intradermal administration of vaccine.

• They will coordinate and manage response efforts across the White House and all Federal departments and agencies.