Latest news with #Sahpra
Daily Maverick
30-05-2025
- Health
- Daily Maverick
Understanding shingles: Risks, vaccination gaps, and the quest for better health solutions
The only shingles vaccine on the market in South Africa was discontinued in 2024. A newer and better vaccine is being used in some other countries, but has not yet been registered in South Africa, though it can be obtained by those with money who are willing to jump through some hoops. Shingles is a common and painful condition that mostly affects the elderly and people with weakened immune systems. It generally appears with a telltale red rash and cluster of red blisters on one side of the body, often in a band-like pattern. 'Shingles is pretty awful to get – it's extremely painful, and some people can get strokes, vision loss, deafness and other horrible manifestations as complications,' said infectious disease specialist, Professor Jeremy Nel. 'Shingles really is something to avoid, if at all possible.' One way to prevent the viral infection is to get vaccinated. But while two vaccines against shingles have been developed and broadly used in the developed world, neither is available in South Africa. Two vaccines Zostavax, from the pharmaceutical company MSD, was the first vaccine introduced to prevent shingles. It was approved for use in the US in 2006 and in South Africa in 2011. It is 51% effective against shingles in adults over 60. A more effective vaccine, Shingrix, which is more than 90% effective in preventing shingles, was introduced by GlaxoSmithKline (GSK) in the US in 2016. It is not yet authorised for use in South Africa, but GSK has submitted paperwork for approval with the South African Health Products Regulatory Authority (Sahpra), said company spokesperson Kamil Saytkulov. The superior protection offered by Shingrix compared with Zostavax quickly made it the dominant shingles vaccine on the market. As a result, MSD discontinued the production and marketing of Zostavax. MSD spokesperson Cheryl Reddy said Zostavax was discontinued globally in March 2024. Before then, the vaccine was sold in South Africa's private healthcare system for about R2,300, but it was never widely available in government clinics or hospitals. No registered and available vaccine Since Zostavax has been discontinued and Shingrix remains unregistered, the only way to access a vaccine against shingles in South Africa is by going through the onerous process of applying to Sahpra for a Section 21 authorisation – a legal mechanism that allows the importation of unregistered medicines when there is an unmet medical need. 'Access will only be available to those who are able to get Section 21 approval' and 'this is a costly and time-consuming process, requiring motivation by a doctor,' said Dr Leon Geffen, director of the Samson Institute for Ageing Research. The cost of the two-dose Shingrix vaccine imported through Section 21 authorisations is currently about R15,600, said Dr Albie de Frey, CEO of the Travel Doctor Corporate. People who seek Section 21 authorisation typically have to pay for this out of their own pockets. 'Shingrix is not covered [by Discovery Health] as it is unregistered in South Africa and is therefore considered to be a General Scheme Exclusion,' Dr Noluthando Nematswerani, chief clinical officer at Discovery Health, told Spotlight. The Department of Health did not respond to queries about whether Section 21 processes are being pursued for priority patients in the public sector or whether there has been any engagement with GSK on the price of this product. People who receive organ transplants, for example, should be prioritised to receive the shingles vaccine since the medications they are given to suppress their immune system puts them at high risk of developing shingles. Why is the price of Shingrix so high? Unlike South Africa, where companies must sell pharmaceutical products at a single, transparent price in the private sector, the US has no such requirement. Even so, the US Centers for Disease Control and Prevention (CDC) pays $250 (R4,600) for the two-dose Shingrix vaccine through CDC contracts. This is less than a third of the charge when Shingrix is imported to South Africa. Equity Pharmaceuticals, based in Centurion, Gauteng, is importing GSK's Shingrix for patients who receive Section 21 authorisations to use the unregistered vaccine. It is unclear what price Equity Pharmaceuticals is paying GSK for Shingrix to be imported under Section 21 approvals, or what its mark-up on the medicine is. Asked about the price of Shingrix in South Africa, Saytkulov told Spotlight: 'Equity Pharmaceuticals is not affiliated with GSK, nor is it a business partner or agent of GSK. Therefore we cannot provide any comments with regards to pricing of a non-licensed product, which has been authorised for importation through Section 21.' Equity Pharmaceuticals also said it was difficult to comment on the price. 'The price of a Section 21 product depends on a number of fair considerations, including the forex rate, the quantity, transportation requirements, and the country of importation. Once the price and lead time are defined for an order, the information is shared with the healthcare provider to discuss with their patient and the medical aid,' the company's spokesperson, Carel Bouwer, said. Nematswerani pointed out that 'Section 21 pricing is not regulated' and that the price can change due to many factors including supplier costs, product availability and inflation. What causes shingles? Shingles is caused by the same highly infectious virus that causes chickenpox. Most people are infected with the varicella-zoster virus (VZV) during childhood. Chickenpox occurs when a person is first infected by VZV. When a person recovers from chickenpox, the VZV virus remains dormant in their body but can reactivate later in life as the immune system weakens. This secondary infection that occurs, typically in old age when the dormant virus reactivates, is called shingles. People who were naturally infected with chickenpox, as well as those vaccinated against chickenpox with a vaccine containing a weakened form of the VZV virus, can get shingles later in life. But, people who were vaccinated against chickenpox have a significantly lower risk of developing shingles later in life compared with those who naturally contracted chickenpox, according to the World Health Organization (WHO). The chickenpox vaccine is available in South Africa's private sector but is not provided in the public sector as part of the government's expanded programme on immunisation. Chickenpox is usually mild in most children, but those with weakened immune systems at risk of severe or complicated chickenpox should be vaccinated against it, said Professor James Nuttall, a paediatric infectious diseases sub-specialist at the Red Cross War Memorial Children's Hospital and the University of Cape Town. Who should be vaccinated against shingles? South Africa does not have guidelines for who should receive the shingles vaccine and when. The US CDC recommends that all adults older than 50 receive the two-dose Shingrix vaccine. It also recommends that people whose immune systems can't defend their body as effectively as they should, like those living with HIV, should get the vaccine starting from age 19. While Shingrix works better than Zostavax at preventing shingles, it has other advantages that make it a safer and better option for people with weak immune systems. The Zostavax vaccine contains a weakened live form of the VZV virus and thus poses a risk of complications in people with severely weakened immune systems. 'In the profoundly immunosuppressed, the immune system might not control the replication of this weakened virus,' explained Nel. The Shingrix vaccine does not contain any live virus and therefore does not present this risk. In March 2025, the WHO recommended that countries where shingles is an important public health problem consider the two-dose shingles vaccine for older adults and people with chronic conditions. '[T]he vaccine is highly effective and licensed for adults aged 50 and older, even if they've had shingles before,' according to the WHO. It advised countries to weigh up how much the vaccine costs with the benefits before deciding to use it. The cost of not vaccinating against shingles The cost of not vaccinating against shingles is high for people who develop the condition, as well as the health system. '[T]he risk of getting shingles in your lifetime is about 20 to 30%… by the age of 80 years, the prevalence is almost 50%,' said Geffen. 'Shingles is often a painful, debilitating condition, with significant morbidity. It can result in chronic debilitating pain which affects sleep, mood and overall function,' he added. Beyond preventing shingles and its complications, new evidence suggests that getting the vaccine may also reduce the risk of developing dementia and heart disease. In April, a large Welsh study published in Nature reported that people who received the Zostavax vaccine against shingles were 20% less likely to develop dementia seven years after receiving it compared with those who were not vaccinated. In May, a South Korean study published in the European Heart Journal reported that people vaccinated against shingles had a 23% lower risk of cardiovascular events, such as stroke or heart disease, for up to eight years after vaccination. DM
TimesLIVE
29-05-2025
- Health
- TimesLIVE
A medical breakthrough, or a dangerous shortcut? Health Beat investigates the ketamine craze
In the latest episode of Health Beat, we unpack the growing use of the psychedelic drug, ketamine, to treat severe depression and chronic pain. Research shows it can work quickly to improve mood, but experts are concerned about the rise of unregulated clinics using ketamine in ways that aren't backed by solid evidence or properly supervised. What began as a good anaesthetic because of its pain-beating properties has evolved into a so-called game-changing treatment for depression, but with no clear guidelines, clinics are cashing in. Also linked with the party scene and celebrity scandals, ketamine is promoted online as a treatment for migraines, anxiety, addiction and ADHD, but are these claims credible? In South Africa, doctors can prescribe ketamine, even though drip infusions haven't been approved by our medicines regulator, Sahpra, for anything outside anaesthesia. Specialists warn that ketamine therapy requires expert training and monitoring. Psychiatrist Bavi Vythilingum, who runs a clinic offering ketamine infusions with an anaesthetist present, reports good results, but is concerned about 'cowboy clinics' run by doctors without extra training in psychiatry and anaesthesiology.
IOL News
23-05-2025
- Health
- IOL News
Sahpra approves first mpox diagnostic test to enhance global health efforts
South Africa has approved the first mpox diagnostic test, bolstering efforts to improve testing access across the globe. Image: Se-Anne Rall/IOL The South African Health Products Regulatory Authority (Sahpra) has made significant strides in combating mpox (formerly known as monkeypox) by approving the Alinity m MPX assay as the first in vitro diagnostic (IVD) test for the virus. This approval, facilitated through reliance on the World Health Organization's (WHO) Prequalification (PQ) assessment and Emergency Use Listing (EUL), marks a pivotal moment in enhancing global access to mpox testing. According to Dr Boitumelo Semete-Makokotlela, Sahpra's Chief Executive Officer, the timely listing of this diagnostic assay is a considerable milestone in efforts to leverage regulatory reliance mechanisms for improved health outcomes. 'For Sahpra to have been able to list this assay timeously, post a WHO PQ EUL, this marks a significant milestone in aiding global access to mpox testing by leveraging regulatory reliance mechanisms,' she stated. In the backdrop of ongoing mpox outbreaks, the emergency use approval of the Alinity m MPX assay, developed by Abbott Molecular Inc. and licensed to Abbott Laboratories South Africa (Pty) Ltd, is paramount. The nature of mpox necessitates rapid and accurate testing for early detection, timely treatment, and overall effective containment of the virus. Currently, only nasopharyngeal RT-PCR (reverse transcription polymerase chain reaction) tests are under consideration by SAHPRA for mpox diagnostics. Video Player is loading. Play Video Play Unmute Current Time 0:00 / Duration -:- Loaded : 0% Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Background Color Black White Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Transparent Window Color Black White Red Green Blue Yellow Magenta Cyan Transparency Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Advertisement Next Stay Close ✕ Healthcare agencies, including the African Centres for Disease Control and Prevention (Africa CDC) and WHO, have emphasised that there is a lack of independently validated antigen rapid diagnostic tests (RDTs) in the market with a clinical sensitivity of at least 80% for mpox testing. As a result, antigen and antibody rapid test kits, including self-test versions, are not recommended at this time. The regulatory requirements for mpox diagnostics can be found in a detailed communication to industry stakeholders, specifically under Issue No.: MD01-2024/25 v1. The document is readily available on Sahpra's official website, which provides guidance on further WHO recommendations regarding mpox diagnostics. IOL
Daily Maverick
13-05-2025
- Health
- Daily Maverick
The dual nature of clinical trials: Unpacking the risks and rewards for South African participants
Clinical trial participants appear to be well protected in South Africa, particularly as the country's guidelines recognise the risks of research with international collaborators. The sudden end of US-funded clinical trials, however, is exposing some limitations of ethics codes and guidelines, argues Dr Andy Gray. Participation in a clinical trial that involves the use of an investigational product, such as an unapproved medicine, can be viewed from two different perspectives. On the one hand, it may represent an opportunity for someone with an unmet medical need to access a promising new treatment or a means to prevent a condition for which the individual is at high risk. On the other hand, it can be seen as an altruistic act, accepting possible risks from the use of the investigational product in order to contribute to the development of new knowledge. Modern research ethics procedures recognise the vulnerability of trial participants and seek to protect them from exploitation and potential harms. The 2003 National Health Act created a new structure in South Africa, the National Health Research Ethics Council (NHREC). Appointed by the Minister of Health, the council is required to develop guidelines for health research ethics committees, register and audit such committees, and set the norms and standards for conducting clinical trials. Section 73 of the act requires every institution or health establishment where health research is conducted to 'establish or have access to a health research ethics committee' registered by the council. The necessary regulations that enabled Section 73 to come into effect were finally published in 2014. In addition, all clinical trials of medicines require prior approval by the South African Health Products Regulatory Authority (Sahpra). A Sahpra staff member also forms part of the council. At first glance, therefore, clinical trial participants in South Africa appear to be well protected. Ethics committees Two locally developed official documents guide the appraisal of applications by health research ethics committees and Sahpra. The national Department of Health issued an updated, third edition of the South African Ethics in Health Research Guidelines: Principles, Processes and Structures in 2024. The guidelines were developed by the council, in accordance with its legislative mandate. The third edition of the South African Good Clinical Practice: Clinical Trial Guidelines were issued by the department, with Sahpra, in 2020. Both of these documents acknowledge the existence of global guidance documents and codes, most notably the World Medical Association's Declaration of Helsinki, which was last updated in late 2024. Although developed by a federation of medical associations, the Declaration of Helsinki is considered to be authoritative and is commonly referenced by national guidelines and regulatory documents. The revision of the Declaration of Helsinki, which commenced in 2022, involved reconsideration of a number of clauses, including the protection of participants in economically vulnerable settings, and post-trial provisions and benefits. Post-trial access ensures that those who have been shown to benefit from a new medicine are not denied the use of that medicine until it is routinely available in their country and health system. These provisions are even more important when new and expensive medicines may not be accessible in low- or even middle-income countries because of high prices or delays in marketing. Clause 20 now reads: 'Medical research with individuals, groups, or communities in situations of particular vulnerability is only justified if it is responsive to their health needs and priorities and the individual, group, or community stands to benefit from the resulting knowledge, practices, or interventions. Researchers should only include those in situations of particular vulnerability when the research cannot be carried out in a less vulnerable group or community, or when excluding them would perpetuate or exacerbate their disparities.' Clause 34 now reads: 'In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or governments for all participants who still need an intervention identified as beneficial and reasonably safe in the trial. Exceptions to this requirement must be approved by a research ethics committee. Specific information about post-trial provisions must be disclosed to participants as part of informed consent.' When studies are stopped abruptly Since January 2025, a number of executive orders issued by the new United States administration and other actions have led to the abrupt cessation of USAid-funded clinical trials being conducted in South Africa. There is ongoing uncertainty regarding trials that are funded by other US federal agencies, notably the National Institutes of Health. These include multi-centred studies conducted by the Division of Aids clinical trials networks. Hence the question: are participants in South Africa protected, sufficiently, when a sponsor withdraws support for an ongoing clinical trial? That South African trial participants are particularly vulnerable is indisputable. In a country still marked by poverty and high unemployment, combined with a high burden of HIV and tuberculosis, and with most of the population dependent on an over-stretched and under-resourced public health sector, participation in a clinical trial offers the opportunity to access services that might not otherwise be available or of an acceptable standard. However, whether 'the individual, group, or community stands to benefit from the resulting knowledge, practices, or interventions' is less clear. Long-acting injectable antiretrovirals for the prevention of HIV remain out of reach, despite the contribution of South African participants in the pivotal trials of these technologies. That such trials could be conducted most efficiently in areas of high HIV incidence adds to the moral imperative to ensure access to the benefits that accrued. Apart from standard provisions for the fair selection of participants, the South African guidelines recognise the risks of research with international collaborators. The guidelines call for explicit memoranda of understanding covering expectations, roles and contributions, including financial arrangements. The Good Clinical Practice guidelines state that a 'signed declaration must be provided by the Sponsor which states that there are sufficient funds available to complete the trial'. Sahpra has a specific guideline on post-trial access or continued access which states: 'Where appropriate and available, the possibility of post-trial access/continued access should be disclosed to and discussed with potential participants during the initial informed consent process or via a separate consent process.' Immediate action The abrupt withdrawal of funding for clinical trials has meant that researchers have had to take immediate action to protect participants from potential harm. For example, when USAid funding for a vaginal ring study was withdrawn, participants were brought back to the trial clinic to remove the rings and provide counselling on alternative HIV prevention options. Researchers are trying to cover the costs of ethically closing studies, providing final clinic visits and referral for all participants. However, the sponsors of these prematurely cancelled studies appear to be evading their responsibilities, even to the extent that they are covered in codes and guidelines. The limitations of those codes and guidelines have been cruelly exposed. South African researchers involved in US-funded studies are required to complete Human Subjects Protection training, covering such US documents as the 1979 Belmont Report and the 'Common Rule'. Every training course includes coverage of the object lessons from the ' Tuskegee Study of Untreated Syphilis in the Negro Male' — a study conducted between 1932 and 1972 that grossly violated several basic principles of medical ethics. Will the events of 2025 and the consequences for clinical trials participants who consented in good faith, only to be abandoned for ideological and political reasons, be among the examples of unethical conduct provided to future health researchers undergoing ethics training? DM *Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is the third of a new series of #InsideTheBox columns he is writing for Spotlight.
Mail & Guardian
30-04-2025
- Health
- Mail & Guardian
The ugly side of the beauty industry: How an unregulated market puts people at risk
From billboards to social media, consumers are bombarded with adverts promising youthful, flawless skin. These marketing campaigns often feature celebrities and influencers, creating the illusion that the right product can unlock the secret to eternal beauty. From billboards to social media, consumers are bombarded with adverts promising youthful, flawless skin. These marketing campaigns often feature celebrities and influencers, creating the illusion that the right product can unlock the secret to eternal beauty. A stroll down the cosmetic aisles of South African retail stores shows shelves overflowing with serums, creams and lotions, each claiming to be the ultimate skincare solution. But behind the glossy packaging and persuasive endorsements lies an industry that is largely unregulated, leaving consumers vulnerable to misleading claims and potential health risks. In an age where skincare serums promise radiance and hair oils tout miracle growth, the average South African consumer might assume that the beauty products lining our shelves are both safe and scientifically vetted. But beneath the glossy labels and celebrity endorsements lies a disconcerting truth — South Africa's cosmetics industry operates in a regulatory grey zone. Unlike medicines or medical devices, cosmetics are subject to minimal oversight. This regulatory gap leaves the public vulnerable to unsafe ingredients, misleading claims and potentially serious long-term health risks. Who's (not) watching the shelves? The This distinction creates a dangerous loophole. If a product merely claims to 'beautify,' 'cleanse' or 'enhance appearance', it evades the kind of scrutiny applied to medicines — even if it contains active ingredients like retinoids, hydroquinone or alpha hydroxy acids. These substances, while effective, can be harmful when misused or poorly formulated. Yet under current law, they often avoid the testing and licensing required for pharmaceuticals. Sahpra only intervenes if a product crosses into the murky territory of being considered a 'medicine', as per the Medicines and Related Substances Act (Act 101 of 1965). But even then, enforcement tends to be inconsistent and reactive, rather than preventative. Looking abroad: Lessons from the FDA The US's Recent reforms under the Modernisation of Cosmetics Regulation Act of 2022 have gone even further — requiring manufacturers to register facilities, disclose ingredients (including allergens) and adhere to stricter safety standards. South Africa, by contrast, is still bumping between two regulatory bodies: Sahpra and the This self-regulation model is outdated — and dangerous. The cost of self-regulation Companies that comply with high safety and manufacturing standards find themselves unfairly competing with backyard formulators who may lack proper training and equipment. As an industry player, it is frustrating. Qualified practitioners spend on Sahpra licenses, the department of health, the Pharmacy Council compliance — but find themselves competing with people mixing products in their garages. They buy raw ingredients off retail shelves, while law-abiding practitioners source pharmaceutical-grade ingredients with proper certificates of analysis and technical data sheets. But it's not just the ingredients that matter — it's the method. The process of formulation — the temperatures, mixing phases, emulsification — determines the safety and effectiveness of the final product. For trained professionals, method is intellectual property. For hobbyists, it's guesswork. Vulnerable consumers, serious risks The consequences of poor oversight are especially visible in the proliferation of skin-lightening products, many of which still contain banned substances like mercury and high concentrations of hydroquinone. Despite their illegality, such products remain widely available — especially in informal markets. A 2015 study published by Without a national database to track adverse reactions, consumers have little recourse. And without enforcement, manufacturers have little incentive to improve. What needs to change? Strengthen Sahpra's mandate . Sahpra must be empowered — both legally and operationally — to regulate cosmetics, especially products with active ingredients or those targeted at vulnerable demographics such as children or people with sensitive skin. The binary classification of 'cosmetic' versus 'medicine' is outdated. We must recognise the growing category of cosmeceuticals, which straddle both definitions. Introduce mandatory ingredient disclosure and pre-market safety checks. All cosmetics should be registered in a central database, with full disclosure of ingredients and safety data. High-risk substances should be restricted or banned outright, in line with the Establish a national adverse event reporting system. Dermatologists, pharmacists and consumers need a streamlined platform to report harmful reactions. These reports can then inform recalls, public alerts and safer industry practices. Prioritise public education. Consumers often assume 'natural' means 'safe' and might not know that salon or online products are not always regulated. The government, media and healthcare professionals should collaborate to raise awareness about how to read cosmetic labels and recognise harmful ingredients. The influence of unqualified voices In today's digital age, science often plays second fiddle to social media. Qualified professionals with years of experience in formulation science are sidelined in favour of popular influencers with no background in chemistry or dermatology. It's a troubling trend. Many doctors launching cosmetic brands might never have studied formulation at all — yet their status lends credibility. Qualifications matter. Just as one wouldn't trust an influencer to perform surgery, consumers shouldn't rely on popularity as a substitute for proper formulation expertise. Toward a safer beauty future South Africa prides itself on its progressive Constitution and commitment to human rights. That commitment should extend to the safety of everyday products used by millions — especially women, who make up the vast majority of cosmetic consumers. With proper regulation, the beauty industry can be a force for empowerment, confidence and economic growth. But without it, we risk a ticking time bomb of preventable health issues. The time has come for Sahpra — in partnership with lawmakers, civil society and qualified experts — to take urgent action. Consumers deserve more than pretty packaging and lofty promises. They deserve safety, transparency and trust. A call for action: Regulations, retailers and consumer awareness Dodgy labelling hides nasty ingredients and a lack of proper checks on products means problems often go unnoticed, putting the public at risk. We need strict rules forcing companies to fully disclose ingredients and ban known toxins, alongside properly funded regulators who can investigate complaints and prosecute wrongdoers. But that's not all — we need to educate the public so they can make informed choices. It's time for Sahpra and other relevant authorities, including the department of health, to step up and close regulatory gaps in the cosmetics sector. We should also challenge unrealistic beauty standards that fuel demand for these products, promoting a more inclusive and healthy view of beauty. As an industry player, action is needed to protect the public. It's about transparency, responsibility and empowering consumers to break free from this dangerous cycle for the health of our communities. Dr Judey Pretorius is a biomedical scientist with expertise in wound healing, regenerative medicine and cell therapy. She has a master's in genetics and molecular biology and a PhD in pharmaceutical chemistry and is the founder of Biomedical Emporium.
