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- South Africa has received enough medicine to treat 10 severe cases of Mpox.
- The country has reported 13 cases since the beginning of May.
- Drugs used globally to treat Mpox are not registered for use in the country.
South Africa received a shipment of the drug to treat 10 severe cases of Mpox.
However, experts warn that the lack of registration for the Mpox vaccine and treatment could become a problem if cases grow exponentially.
The Ministry of Health said on Thursday that 13 confirmed cases of Mpox have been reported since the beginning of May. Six of them were confirmed within a week.
Health department spokesman Foster Mohale said the department has received a shipment of a specialized treatment for Mpox called Tecovirimat to treat patients who have experienced serious health complications from the disease.
He added that steps were being taken to ensure greater access to treatments and vaccines.
Read more | Health authorities receive first batch of drugs for specific diseases, Mpox cases rise to 13
Mohale said the batch of vaccines “currently contains 10 doses that can be used to treat all serious health complications.”
However, most cases reported so far have been mild and have been managed with “supportive care.”
“We anticipate that there will be some increase in stocks and our treatment measures will be dictated by the infection rate,” he said.
The department has received a shipment of Tecovirimat (also known as TPOXX or ST-246), a specific drug for mpox, for use in patients with severe complications from the disease. Efforts to obtain additional treatments, including vaccines, are ongoing. #Mpox pic.twitter.com/6uYKygBELn
— National Department of Health (@HealthZA) June 21, 2024
News24 understands that the drug is not yet registered in South Africa and is being applied for use under section 21 with the South African Health Products Regulatory Authority (Sahpra).
Vaccines used in other countries to prevent Mpox are also not registered in South Africa.
Sahpra spokesperson Madimetja Mashishi said South Africa has not yet received a registration application for Tecovirimat.
“However, a named patient Article 21 authorization for Tecovirimat to treat Mpox has been granted to the applicant (treatment practitioner). A Bulk Stock Article 21 authorization has also been granted to the National Ministry of Health to facilitate the importation of Tecovirimat donated by WHO. The drugs will be distributed only upon presentation of the named patient authorization,” Mashishi said.
Tecovirimat is used to treat smallpox in the U.S. In the European Union, it is used to treat smallpox, swine pox and cowpox, Mashishi said.
this Centers for Disease Control website The statement said that because “there is insufficient data to show whether tecovirimat is safe and effective for treating patients with Mpox, tecovirimat is still considered an investigational drug for Mpox.” This means that the drug is still being tested to see if it is safe and effective in treating a specific condition.
Mashishi added that so far, “there has been no registration and no Article 21 application for approval of the Mpox vaccine”.
“Smallpox vaccines have been shown to be effective in preventing (smallpox) and reducing the severity of the disease. These vaccines can be imported through the Article 21 authorization process,” he said.
Mohale said the Mpox vaccine was not currently available in South Africa, adding that regulatory approval would depend on where the vaccine was registered, “and which country’s dossier our regulators will use for their review”.
Health Minister Joe Phaahla previously said the World Health Organization (WHO) recommends the use of Tecovirimat to treat severe cases, such as individuals with CD4 counts below 350.
The drug is currently being used to treat patients in South Africa.
Fahra says:
As for vaccines, South Africa is considering which groups to target. South Africa is trying to procure vaccines from WHO member states that have stocks in excess of its needs, as well as from GAVI, the Vaccine Alliance. These vaccines will be stored and distributed from our provincial warehouses.
Nevashan Govender of Nigeria’s National Institute for Communicable Diseases said two vaccines “have been approved for use in the treatment of Mpox but have not yet received prequalification approval from the WHO”.
“These are MVA-BN and LC16m8. LC16m8 is not recommended for use in severely immunocompromised people. MVA-BN is being used worldwide, including for people living with HIV and other immunocompromised people, and is being provided in the Democratic Republic of the Congo for treatment of all age groups, including children, the elderly (and) pregnant women.”
Govender said a special technical working group of the local National Advisory Committee on Immunization is making a recommendation to the state health department to consider offering the MVA-BN vaccine for both pre-exposure and post-exposure administration to high-risk groups.
Dr Richard Lessers, an infectious disease specialist at the University of KwaZulu-Natal, said Tecovirimat is currently the most widely used drug for treating Mpox. However, it is not yet registered in South Africa and must be specifically approved by Sahpra for use.
“Patients generally receive a two-week course of treatment, but in severe cases, the treatment may take longer,” he said.
“The reality is that we don’t know how well it works. Trials have been done but the results haven’t been reported. We do know that doctors and scientists around the world have reported positive results, which is enough to say that we should use it in severe cases and patients who are at risk of severe illness.”
However, the lack of Tecovirimat could become a stumbling block if a large-scale poxvirus outbreak occurs in South Africa.
“At the moment, it’s not a major obstacle. We don’t have a large stockpile and we don’t have a large number of cases. But if it expands, South Africa will need to speed up the approval process,” said Lesserse.
Also read | Mpox in South Africa: Here’s what we know so far
Lessers added that vaccines have been used successfully overseas to provide protection to groups most at risk of infection.
“Some countries may have excess vaccine supplies that they are willing to donate to South Africa. The health sector also needs to think about the right strategy for deploying the vaccine, such as which groups to prioritise. This will not be like Covid-19, where the vaccine was offered to the general population. Vaccination should target those at highest risk of infection and those at risk of severe illness.”
Professor Linda-Gail Baker, director of the Desmond Tutu AIDS Centre at the University of Cape Town and an infectious disease expert, said South Africa should not delay approving the Mpox vaccine.
she says:
We shouldn’t have waited for a large outbreak to declare Mpox a potential public health risk. Wouldn’t it be better to consider vaccinating people we know are at risk instead of waiting?
Becker added that health departments need to consider several factors before launching vaccination campaigns, including who will pay for the vaccines and how they will be procured.
“There may be people willing to pay for the vaccine, and there may even be health aid agencies willing to cover the cost for clients. And it’s unlikely that the department will be able to roll out this vaccine to everyone,” she said.
“Prevention is always better than cure. How many cases do we need to see before we take action?”
The last time South Africa recorded a positive case of Mpox was in 2022, when five cases were confirmed in the Western Cape, KwaZulu-Natal, Limpopo and Gauteng provinces.
According to WHO, between January 1, 2022 and April 30, 2024, a total of 97,208 laboratory-confirmed cases of Mpox, including 186 deaths, were recorded worldwide from 117 countries.
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