Mpox

vaccine

SAMWUMED HPU Memorandum: Monkeypox (Mpox) Management

Purpose

The purpose of this document is to provide the latest updates on the management of the mpox virus. The document provides a brief overview of potential therapeutic options that may emerge in the near future. This information builds upon the recent mpox outbreak in South Africa.

Preventive care

The main mode of mpox prevention is vaccination. Mass vaccination against mpox is not currently recommended but specific high-risk groups are encouraged to receive the vaccine as they face a notably higher risk of contracting mpox compared to the general population.

These groups comprise of healthcare workers, sex workers and MSM (Men Who Have Sex with Men).

Dr. Joe Phaahla, South Africa’s Minister of Health, recently announced that mpox vaccine shipments are anticipated to arrive in the coming weeks. These vaccines will be stored at provincial health department depots and will be readily accessible at healthcare clinics. Mpox

vaccines are not currently available for private purchase in South Africa. The country is sourcing these vaccines from Gavi (the Vaccine Alliance) and Western European nations with surplus supplies.

Mpox shares genetic similarities with the smallpox virus. Individuals, typically over the age of 40 years old, who have previously received the smallpox vaccine (currently no local access) exhibit partial protection against mpox. The smallpox vaccine demonstrates approximately

85% effectiveness against the mpox virus, either preventing the disease or reducing its severity if acquired. Despite their genetic similarity, these remain distinct viruses. Having previously received the smallpox vaccine should not prevent administration of the mpox vaccine for eligible individuals, if recommended by the treating healthcare provider.

Other non-pharmacological preventative measures include effective tracing, isolation and quarantine (varying from 3-17 days) procedures. As well as good personal hygiene (e.g., frequent handwashing), regularly cleaning and disinfecting surrounding surfaces/objects, thoroughly cooking all animal meat, practicing safe sex, and using face masks and Personal Protective Equipment (PPE) when in contact with infected people or animals.

Preventive care

The approach to treating mpox infection is similar to that of other viral infections. For most cases, specific therapeutic interventions are unnecessary, as the virus is primarily self-limiting.

Treatment focuses on providing supportive care and symptomatic relief.

It is important to note that supportive care is not limited to out-of-hospital settings and in severe cases hospitalisation may be necessary. Various scenarios, such as excessive nausea, vomiting or dysphagia, may warrant referral to a hospital facility to manage symptoms and

complications such as dehydration. Additionally, patients with severe disease or complications may require hospitalization for pain management and observation.

Therapeutic intervention, such as antivirals, may be necessary for severe cases of mpox infection. Patients at risk of developing severe mpox disease include children under 8 years of age, individuals with a history of atopic dermatitis, those with exfoliative skin conditions, pregnant or breastfeeding mothers, and immunocompromised individuals (though this list is not exhaustive).

At present, there is no locally approved antiviral drug specifically indicated for the mpox infection. The use of existing antiviral medications in this context would be considered offlabel; however, it may be considered appropriate on a case-by-case basis.

The World Health Organisation (WHO) recommends the use of an antiviral called tecovirimat (also known as TPOXX) for treating severe cases. This drug can be used in patients living with HIV with a CD4 count below 350. In South Africa, the Department of Health (DoH) have acquired tecovirimat through the Section 21 SAHPRA approval process on compassionate use for those who experience severe health complications due to the disease. This drug is not currently available for private purchase in South Africa.

Mpox, being genetically similar to the smallpox virus, allows for the consideration of certain antiviral drugs initially developed for smallpox treatment. In the United States, several antiviral drugs are available for various orthopoxvirus infections, each with distinct FDA-approved

indications. Among these, tecovirimat and brincidofovir have received more recent (2022) licensing for mpox treatment. However, data on their efficacy in human cases of mpox is limited, primarily drawn from observations in animal studies. In the U.S., unregistered products can be accessed through an expanded access protocol during an orthopoxvirus outbreak (1) (2) (3) (4) (5).

Agent

Original FDA approval

FDA indication for mpox

Local approval

Tecovirimat

Smallpox

Yes (since 2022)

No
Subject to Section 21

Cidofovir

Cytomegalovirus (CMV) – associated with HIV/AIDS

No – expanded access protocol

No
Subject to Section 21.

Brincidofovir

Smallpox

Yes (2022)

No

Vaccinia Immune Globulin Intravenous (VIGIV)

Vaccinia infections

No – expanded access protocol

No

The off-label use of topical anti-viral therapy (e.g., triflourodine and vidarabine) may also be beneficial for infections spreading to atypical sites, such as the mouth, eyes, or genitals (2).

Local prevalence

According to the DoH, as at 21st June 2024, South Africa has reported 13 laboratory confirmed cases of mpox, resulting in 2 fatalities. These cases are distributed across three provinces: Gauteng (5), KwaZulu-Natal (7), and Western Cape (1). Affected patients were mainly men aged 30 to 39 years, and none had a recent travel history to countries experiencing an outbreak. Their illnesses were severe, necessitating hospitalization. South Africa now joins the list of countries facing a mpox outbreak.

Medscheme member impact

Data extracted from 1 January 2024 to 20 June 2024 indicates a total of 7 mpox-related hospital admissions across Medscheme Client Schemes with none for SAMWUMED. During this period, 20 unique beneficiaries across Medscheme Client Schemes claimed for other services such as pathology, consultations, consumables, or medicines with none for SAMWUMED. To note that this data is based on submission for services against the mpox ICD10 code (i.e., B04).

Provisional data on the geographical location of these members indicates that among the 20 unique members, the highest numbers of infection were observed in the Eastern Cape and Gauteng, followed by the Western Cape as per the table below. This data is insufficient to
comment on any notable trends related to geographical location.

Province

Unique beneficiary claims

EASTERN CAPE

6

GAUTENG

6

KWAZULU-NATAL

1

NORTHWEST

3

WESTERN CAPE

4

Total

20

Claims impact on medicine

According to the claims data, only one antiviral drug has been claimed under the mpox ICD- 10 code. This is a combination antiretroviral agent called Acriptega®. Acriptega® consists of lamivudine, tenofovir disoproxil and dolutegravir and is indicated for the treatment of HIV-1 (human immunodeficiency virus-1) infection. This drug was only claimed by one member monthly since January 2024 whom resides in KwaZulu-Natal and who are on another medical scheme. There have been no claims for the internationally available antivirals mentioned above.

Conclusion

Medscheme will continue to monitor the published literature, SAHPRA registration updates (vaccines and antivirals) and DoH alerts regarding availability of a mpox vaccines and treatments, as well as the process to acquire these for the benefit of our client schemes and members.

The DoH urges anyone with suspected mpox symptoms or who had physical contact with known cases to present themselves at a healthcare facility.

Mpox Outbreak Frequency Asked Questions

What is Mpox?

In November 2022, the World Health Organization (WHO), renamed “monkeypox” to “mpox” to reduce the risk of stigmatization associated with the term.

Mpox is a zoonotic disease (infectious disease that can be transmitted from animals to humans) caused by the monkeypox virus (MPXV). This virus belongs to the orthopoxvirus genus within the poxviridae family.

Where does mpox come from?

The exact source of mpox is unknown. It acquired its name after being discovered in 1958 in colonies of monkeys being kept for research. African rodents and primates (such as monkeys) are known carriers of this virus and may infect humans. The first documented human case of mpox occurred in 1970.

Mpox in South Africa

According to the Department of Health (DoH), as at 21st June 2024, South Africa has reported 13 laboratory-confirmed cases of mpox, resulting in 2 fatalities. These cases are distributed across three provinces: Gauteng (5), KwaZulu-Natal (7), and Western Cape (1). Affected patients were mainly men aged 30 to 39 years, and none had a recent travel history to countries experiencing an outbreak. Their illnesses were severe, necessitating hospitalization. South Africa now joins the list of countries facing a mpox outbreak.

How is mpox spread and how can it be prevented?

Mpox can be spread via direct contact with infected animals and humans through blood, bodily fluid, skin or mucous lesions or respiratory droplets. Other routes of transmission may be from bites or scratches, eating infected meat and contact with contaminated items.

Transmission of mpox can be prevented with swift tracing and isolation of suspected and confirmed cases. Other measures include maintaining good personal hygiene, regular sanitization of working surfaces and objects, proper cooking of meat; and using personal protective equipment (PPE) when in contact with infected individuals or animals.

Is there a vaccine for mpox?

The main mode of mpox prevention is vaccination. Mass vaccination against mpox is not currently recommended but specific high-risk groups are encouraged to receive the vaccine as they face a notably higher risk of contracting mpox compared to the general population. These groups comprise of healthcare workers, testing laboratory personnel, sex workers and MSM (Men Who Have Sex with Men).

According to a recent announcement by Dr. Joe Phaahla, the South African Minister of Health, mpox vaccine shipments are expected to arrive in the coming weeks. These vaccines will be stored at provincial health department depots and will be readily accessible at healthcare clinics. South Africa is procuring the vaccines from Gavi (the Vaccine Alliance) and Western European countries with surplus supply.

Mpox shares genetic similarities with the smallpox virus. Individuals, typically over the age of 40 years old, who have previously received the smallpox vaccine in the 1980s exhibit partial protection against mpox. The smallpox vaccine demonstrates approximately 85% effectiveness against the mpox virus, either preventing the disease or reducing its severity if acquired. Despite their genetic similarity, these remain distinct viruses. Having previously received the smallpox vaccine should not prevent administration of the mpox vaccine for eligible individuals, if recommended by the treating healthcare provider.

What are the signs and symptoms?

Mpox follows an incubation period of approximately 7-14 days, although symptoms may manifest anywhere from 5 to 21 days after infection. Early symptoms include (among others) fever, headache, muscle aches, fatigue, chills, and swollen lymph nodes.

Within 1-3 days a rash typically emerges affecting areas such as the face, hands, feet, mouth, genitalia, and eyes. The rash evolves through several stages: macules (flat), papules (slightly raised), vesicles (fluid-filled bumps/ blisters), pustules (yellow fluid-filled bumps/ blisters), and finally, scabs. If left untreated, symptoms may persist for up to one month. Individuals with mpox are contagious while symptomatic, which is typically 2–4 weeks.

Are there serious complications?

Mpox has a low fatality rate and severe complications are rare. More serious complications that may occur include bronchopneumonia, sepsis, encephalitis (inflammation of brain tissue), infection of cornea (which can lead to vision loss) and secondary infections. Although mpox is generally self-limiting, it can be fatal in severe cases. Risk factors may include children (under the age of 8 years old), prolonged virus exposure, those who are immunocompromised and other high-risk groups (i.e., health care workers, sex workers and MSM).

How is mpox treated?

According to the National Institute for Communicable Diseases (NICD) the treatment for mpox is generally supportive (as is the case for most viral infections) and specific therapeutic treatment is often not required. More severe cases may warrant the use of certain antiviral drugs, although there is no locally approved therapy specifically for mpox. The World Health Organisation (WHO) recommends the use of an antiviral named tecovirimat (known as TPOXX) for the treatment of severe cases, such as individuals with a CD4 count of less than 350. Tecovirimat can only be obtained via Section 21 SAHPRA approval process only under compassionate use.

What must be done if there is a suspected case?

When a healthcare provider identifies a suspected case of mpox, immediate implementation of strict isolation and infection-control protocols is required. Thorough contact tracing, documentation, and reporting are essential, along with clear instructions for self-monitoring and self-isolation. Given that most cases resolve on their own, supportive care should be provided, tailored to the specific circumstances and severity of the infection. For risk assessments and additional laboratory investigations, healthcare professionals should contact the NICD hotline at 0800-212-552.

WHO has not issued any travel restrictions related to mpox. Instead, they are collaborating with affected countries to identify potential sources of exposure. Fortunately, the risk of mpox to the South African population remains low.

While the risk of mpox remains low in South Africa, 2 fatalities have been reported. Prevention strategies are thus essential, by means of good overall hygiene and being aware of signs and symptoms. Local mpox vaccine supply is expected in coming weeks and more information related to where and who should be vaccinated will be shared. In general, only supportive therapies are required, however more serious cases may require hospitalisation and administration of antiviral therapy. The DoH urges anyone with suspected mpox symptoms or who had physical contact with known cases to present themselves at a healthcare facility.

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