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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. The US Food and Drug Administration (FDA) on Thursday approved Cabenuva as the first long-acting injectable HIV treatment for patients in stable condition. Cabenuva—a combination of cabotegravir and rilpivirine, injected separately—was shown in clinical trials to suppress HIV to undetectable levels for two years when administered once a month. The monthly injectable medication regimen, developed by ViiV Healthcare, will pose an alternative to existing HIV treatment methods that require daily pills. However, the Cabenuva approval covers only stable HIV patients—those who took daily pills and had undetectable HIV levels before entering the trial—while an ongoing trial is evaluating its efficacy in people unable to take regular oral medications. The list price of the newly approved treatment is roughly $6,000 for the initial dose, followed by around $4,000 per month.Newly inaugurated President Joe Biden last week reversed the former administration’s request to withdraw the United States from the World Health Organization (WHO) and indicated the country will support the WHO-led Access to COVID-19 Tools (ACT) Accelerator, including its global vaccine initiative known as COVAX. The ACT Accelerator aims to ensure all countries have access to COVID-19 treatments, diagnostics, and vaccines, with COVAX intending to secure and distribute 2 billion vaccine doses by the end of 2021—a goal for which fundraising targets remain unmet. The United States has historically been the largest donor to WHO, providing financial support for a wide range of program areas, including pandemic preparedness. In remarks during the WHO Executive Board meeting Thursday, Dr. Anthony Fauci announced the United States’ commitment to WHO and the global COVID-19 response, and WHO Director-General Tedros Adhanom Ghebreyesus welcomed the renewed partnership.On Thursday, Eli Lilly announced its monoclonal antibody prevented COVID-19 infections in a clinical trial among nursing home residents and facility staff. The trial results, released in a press release from the company and currently not published or peer reviewed, showed symptomatic COVID-19 infections were reduced by 57 percent among all participants and by 80 percent among just nursing home residents. Eli Lilly’s chief scientific officer emphasized that the antibody should not be seen as competition to vaccines, but that it could be useful during COVID-19 outbreaks in places vaccines have not reached. The antibody, bamlanivimab, was authorized by the FDA in November to treat COVID-19 patients at risk of severe disease, and Eli Lilly plans to discuss with the FDA whether a new emergency authorization is needed for use in COVID-19 prevention.

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. Interim data from the phase 1/2a clinical trial of Johnson & Johnson’s (J&J) COVID-19 vaccine candidate indicates the single-dose shot induced an immune response and was generally well-tolerated among trial participants aged 18 to 55. Neutralizing antibodies against COVID-19 were observed in more than 90 percent of volunteers 29 days post-vaccination and in 100 percent of volunteers 57 days post-vaccination. The vaccine—the furthest along candidate that only requires one dose—was developed by Janssen Pharmaceutical Companies of J&J using its AdVac vaccine platform, which was also used to develop Janssen’s Ebola vaccine as well as investigational Zika, RSV, and HIV vaccine candidates. The company expects to release data on participants over the age of 65 as well as results from its phase 3 trial later this month, after which it would submit applications for authorization from the US Food and Drug Administration and regulatory bodies globally.The African Union (AU) has secured provisional commitments to procure around 270 million COVID-19 vaccine doses, 50 million of which would be available before April 2021. The doses—to be supplied by Pfizer, AstraZeneca, and J&J—will be distributed among the AU’s 55 member states in pursuit of achieving herd immunity across the content. The new agreements are independent from doses secured through the COVAX Facility, a global mechanism to speed up development, manufacturing, and equitable distribution of COVID-19 vaccines, which has pledged to procure and supply vaccines for about 20 percent of each participating country’s population. The continent’s vaccine strategic plan entails vaccinating at least 60 percent of its 1.2 billion individuals, according to the director of the Africa Centers for Disease Control and Prevention.As the first COVID-19 vaccines—from Pfizer, Moderna, and AstraZeneca—are manufactured and distributed around the world, experts say there will still be plenty of need for follow-up products in the fight against the pandemic. While current vaccine launches provide hope for an end to the “acute phase of the pandemic,” longer-term management of the disease will require a larger arsenal of technologies. The next generation of vaccines could also offer advantages to the fight that the first round could not, including potential for single doses, easier mass manufacturing ability, or less rigid temperate requirements. There are currently at least 20 COVID-19 vaccine candidates in the final phase of clinical trials and dozens more in preclinical and early clinical stages.