Research Roundup: TB combination therapy trials, malaria vaccine contract, and COVID-19 booster approval

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.The World Health Organization (WHO) awarded the first prequalification to an African-manufactured antimalarial drug used to prevention infection in pregnant women and infants. The medicine, sulfadoxine-pyrimethamine, marketed as Wiwal, is made by Kenyan drug company Universal Corporation Limited. The approval is a step toward strengthening local production of medicines, as well as addressing the disproportionate burden of malaria in Africa.An Oxford University research team announced their new PLATINUM trial assessing whether SIGA Technologies’ tecovirimat (Tpoxx) is an effective treatment for monkeypox. The study seeks to recruit at least 500 participants, who will be given a 14-day treatment of two doses daily or a placebo. Tpoxx has been cleared by the United Kingdom and European Union to treat diseases caused by the family of orthopoxvirus that includes smallpox and monkeypox based on studies in animals and healthy humans, though it has only been used in severe cases in Great Britain. In the United States and Canada, the drug has only been approved to treat smallpox. There have been no studies assessing the effectiveness of the drug in hastening recovery in those infected with monkeypox.Moderna announced that it has requested emergency approval from the US Food and Drug Administration (FDA) for its variant-updated COVID-19 vaccine. The vaccine is a booster dose for adults 18 years and older targeting Omicron subvariants B.A.4 and B.A.5. If approved, doses could be ready to ship in September. Moderna’s announcement follows Pfizer and BioNTech’s news that they have applied for FDA approval for their updated booster.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.Scientists in eastern China have identified an animal virus that has jumped to people, infecting 35 since 2018. Named the Langa henipavirus, it causes respiratory symptoms and is closely related to two other human henipaviruses, Hendra and Nipa. While scientists believe the virus is not fatal, nor does it seem to spread easily between humans, experts have urged ongoing surveillance and further research into the virus, especially as zoonotic disease outbreaks become more common worldwide. The virus is believed to be carried by wild shrews although it is unclear whether people are infected directly or indirectly by these animals.Last week, Pfizer and BioNTech announced new trials will start later this month of their updated mRNA vaccine aimed at protecting against the B.A.4 and B.A.5 Omicron subvariants, which have spread quickly and demonstrated heightened ability to evade existing vaccine protection. If the vaccines receive regulatory approval, the companies expect to roll out the updated vaccines by October. The approval process should be quicker than normal as the US Food and Drug Administration (FDA) is not requiring updated clinical data for the B.A.4- and B.A.5-updated shots, instead basing their approval on clinical data from the companies’ Omicron B.A.1-focused vaccine trials, which have already been submitted.The Biden administration is stretching out its limited supply of Jynneos monkeypox vaccine to address the growing public health issue and supply shortage in the face of high demand for the vaccine. On Tuesday, August 9, the FDA issued an emergency use authorization to allow the method of injecting one-fifth of the normal dose amount into the skin rather than a full dose into the fat. The guidance still urges health care providers to continue to follow the regimen of two shots 28 days apart with the lower dose amount. The administration is recommending this method to ensure more high-risk people can access at least some vaccine protection.