News24 | Mpox outbreak: Medication arrives, but lack of formal registration could be a stumbling block

• South Africa has received enough medication to treat 10 cases of severe Mpox.
• There have been 13 cases reported in the country since the start of May.
• The medication used globally to treat Mpox is not yet registered for use in the country.

South Africa has received a batch of medication to treat 10 cases of severe Mpox.

However, experts have warned that the lack of registration for an Mpox vaccine and treatment could become problematic should cases grow exponentially.

On Thursday, the Department of Health said 13 confirmed cases of Mpox had been reported since the start of May. Six of those cases were recorded in one week.

Health department spokesperson Foster Mohale said the department had received a batch of Mpox-specific treatment, called Tecovirimat, for treating patients who experience severe health complications due to Mpox disease.

He added that a process was under way to secure more treatment and a vaccine.

READ MORE | Mpox cases rise to 13, as health department receives first batch of disease-specific medication

The batch contains "10 doses for now, for all severe health complications", said Mohale.

Most of the cases reported so far, though, have been mild and have been managed with "supportive treatment".

"We are expecting a larger stock, and our response with treatment is informed by the rate of infections," he said.

News24 understands the medication, which is not yet registered in South Africa, is being used under a Section 21 application to the South African Health Products Regulatory Authority (Sahpra).

A vaccine being used in other countries to prevent Mpox is also not registered in South Africa.

Sahpra spokesperson Madimetja Mashishi said there had been no application to register Tecovirimat in South Africa.

"However, named-patient Section 21 authorisations have been granted to applicants [treating practitioners] for Tecovirimat for the treatment of Mpox. A bulk stock Section 21 authorisation was also granted to the national Department of Health to facilitate the importation of WHO-donated Tecovirimat. These will only be dispensed when a named-patient authorisation is produced," said Mashishi.

In the US, Tecovirimat is indicated for the treatment of smallpox. In the European Union, it is indicated for the treatment of smallpox, Mpox and cowpox, said Mashishi.

The US Centres for Disease Control website states that as there is "not enough data to say whether Tecovirimat is safe and effective for treating people who have Mpox, Tecovirimat is still considered an investigational drug for Mpox". This means the drug is still being tested to determine whether it is safe and effective to treat a specific disease.

Mashishi added that there had been "no registration nor Section 21 applications to approve vaccines for Mpox" as yet.

"Smallpox vaccines have been shown to be effective in preventing [Mpox] and in reducing the severity of the disease. These may be imported through the Section 21 authorisation process," he said.

Mohale said there were currently no Mpox vaccines in South Africa, adding that regulatory approval would depend on where the vaccine had been registered "and which country's dossier will be used by our regulator to review".

The World Health Organisation (WHO) recommends the use of Tecovirimat for the treatment of severe cases, such as in individuals with a CD4 count of less than 350, Health Minister Joe Phaahla previously said.

The medicine has already been used in the treatment of patients in South Africa.

Phaahla said: 

The National Institute for Communicable Diseases' Nevashan Govender said two vaccines "have been granted indications for Mpox, but do not have WHO prequalification approval yet".

"These are MVA-BN and LC16m8. LC16m8 is not recommended for use in severely immunocompromised people. MVA-BN is being used globally, including for people with HIV and other immunocompromised individuals, and is being administered in the Democratic Republic of Congo for all age groups, including children, the elderly [and] pregnant women."

Govender said that, locally, a special technical working group of the National Advisory Committees on Immunisation was working on recommendations to the national Department of Health to consider the availability of the MVA-BN vaccine for both pre- and post-exposure administration for high-risk groups.

University of KwaZulu-Natal infectious disease specialist Dr Richard Lessells said Tecovirimat was currently the most widely used medication to treat Mpox. However, it was not registered in South Africa and special approval must be given by Sahpra for it to be used.

"Patients are given a two-week course in general, but the treatment can be longer in cases of severe disease," he said.

"The reality is that we don't know how well it works. There have been trials, but no results have been reported yet. We do know that doctors and scientists around the world are reporting positive results, and enough so to say that we should use it in severe cases and in patients at risk of developing severe disease."

However, the lack of availability of Tecovirimat could become a "stumbling block" if South Africa experiences a widespread outbreak of Mpox.

"For now, it's not a major barrier. We have a small stock available and there are not that many cases. But if things expand, South Africa would need to expedite the approval process," said Lessells.

ALSO READ | Mpox in South Africa: Here is what we know so far

Lessells added that vaccines had been used successfully overseas to offer protection to groups at highest risk of infection.

"Some countries might have a surplus supply of vaccines that they would be willing to donate to South Africa. The health department will also need to consider the right strategy to deploy vaccines, such as what groups to prioritise. This will not be like Covid-19, where vaccines were offered to the general population. Vaccination should be targeted for those at highest risk of infection and those at risk of developing severe illness."

Infectious diseases specialist Professor Linda-Gail Bekker, the director of the Desmond Tutu HIV Centre at the University of Cape Town, said South Africa should not drag its heels in approving a vaccine for Mpox.

She said: 

Bekker added that there were factors the health department would need to consider before rolling out a vaccination campaign, including who would pay for the vaccines and how they would be sourced.

"It's likely that there will be people willing to pay for the vaccine, or potentially even medical aids willing to cover the cost for their clients. And the department is not likely to have to roll it out to everyone," she said.

"Prevention is always better than cure. How many cases do we have to have before we act?"

The last time South Africa recorded positive cases of Mpox was in 2022, when five cases were confirmed in the Western Cape, KwaZulu-Natal, Limpopo and Gauteng.

According to the WHO, between 1 January 2022 and 30 April 2024, 97 208 laboratory-confirmed cases of Mpox were recorded, including 186 deaths from 117 countries.