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Last Thursday, the US Food and Drug Administration (FDA) announced its approval of the first vaccine to prevent the disease caused by the chikungunya virus. The Ixchiq vaccine, developed by Valenva, is approved for adults at increased risk of exposure to the virus. It was previously granted fast-track and breakthrough therapy designations from FDA. Chikungunya is a chronic and debilitating disease that has no specific treatment, which has become an increasing global threat due to climate change. FDA is requiring that Valneva perform a post-market study to continue to monitor the vaccine’s safety and side effects.
With support from Medicines for Malaria Venture (MMV), Kenyan manufacturer Universal Corporation Ltd has received prequalification from the World Health Organization (WHO) for sulfadoxine-pyrimethamine plus amodiaquine (SPAQ), an antimalarial drug used to prevent seasonal malaria in children during peak transmission periods. This approval, which makes UCL only the sixth African pharmaceutical company to have a product WHO-prequalified, will allow Africa to reduce reliance on imported generic versions of the drug from India and China. In the face of a myriad of barriers to quality local drug production and a persistently high burden of malaria cases and deaths, the approval will also make it easier for other African companies to enter the market and attract major buyers, as well as ensure the accessibility and availability of the drug where it is most needed and free up national resources to dedicate to other aspects of the malaria response.
A new study found that more than half of tuberculosis (TB) patients in South Africa receiving treatment with a bedaquiline-containing regimen had isolates resistant to the drug, which was introduced in South Africa in 2012 and has recently become part of all standard drug-resistant TB regimens globally. The study is one of the first to report individual-level bedaquiline resistance gain over time among patients in a setting with a bedaquiline-containing regimen as the standard treatment. The results highlight the need for drug-susceptibility testing capacity to accompany the scale-up of new drugs like bedaquiline to monitor the emergence of drug resistance.