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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.Experts are increasingly concerned about connections between Paxlovid, Pfizer’s COVID-19 antiviral drug, and COVID rebound in patients who complete the five-day regimen, especially as Paxlovid use has grown dramatically in recent months. The US Food and Drug Administration (FDA) has asked Pfizer to investigate whether a second course will prevent rebound. A large study previously showed that Paxlovid significantly reduced hospitalizations and deaths in those 65 years and older, but uncertainty remains over the drug’s effectiveness in younger people as well as the link between the drug and COVID rebound. Rebound has also been observed in people who have not taken Paxlovid as well.A new study investigating the effectiveness of the BPaL drug regimen (a combination of bedaquiline, pretomanid, and linezolid) with linezolid at lower doses found that the treatment was still highly effective in patients with drug-resistant tuberculosis (TB) and the number of patients who experienced side effects related to linezolid dropped significantly. BPaL was approved by the FDA in 2019. Although studies showed the drug to be highly effective in drug-resistant TB patients, there was also a high rate of side effects found to be linked to linezolid. The new study, supported by TB Alliance, published in the New England Journal of Medicine indicated that the dosage of linezolid can be halved while maintaining similar efficacy, making the six-month regimen easier and more tolerable for patients.On Wednesday, August 31, the FDA gave emergency use authorizations to Moderna and Pfizer-BioNTech’s Omicron-updated COVID-19 booster shots to be used as single-dose inoculations at least two months after the first booster vaccination. Both vaccines are aimed at targeting both the original COVID-19 and B.A.4 and B.A.4 Omicron subvariants. Whereas Moderna’s booster is approved for all adults 18 years and older, the Pfizer-BioNTech booster is approved for all people 12 years and older. The CDC endorsed the vaccines on Thursday, clearing the way for a quick rollout in the coming weeks. 

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.The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) announced a joint development agreement to support phase 2 trials evaluating two investigational combination treatment regimens for active pulmonary tuberculosis (TB). Both regimens combine already registered products with new chemical entities (NCEs). The first combines delamanid and bedaquiline with two NCEs, OPC-167832 and sutezolid, while the second includes pretomanid and bedaquiline with the two NCEs. The trials will test whether these regimens can substantially shorten treatment duration, with the goal of advancing a suitable regimen into phase 3 development. UNICEF has awarded GSK a contract valued at up to US$170 million to produce the first malaria vaccine. The award will pay for 18 million doses of GSK’s RTS,S vaccine over the next three years. UNICEF has stated their hopes that the award will encourage other malaria vaccine developers to continue to innovate new technologies in order to address the burden of malaria, especially to mitigate preventable deaths of children under five years old from the disease. The United Nations agency expects high demand for the vaccine and believes that costs per dose will decrease over time as supply and manufacturing capacity grow in turn.On Monday, August 15, the UK Medicines and Healthcare products Regulatory Agency (MHRA) gave conditional approval to Moderna’s Omicron variant-updated COVID-19 vaccine for use as a booster in adults. The approval is based on clinical data that demonstrated “strong immune response” against the original virus and B.A.1 subvariant and exploratory analysis showing a “good immune response” against the B.A.4 and B.A.5 subvariants as well as no serious safety concerns. The UK’s Joint Committee on Vaccination and Immunisation followed by supporting the use of the updated vaccine the national booster shot campaign starting next month.