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Research Roundup: Malaria R&D, COVID-19 drug candidates, and Ebola vaccine trial questions

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PATH/Georgina Goodwin

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

December 12, 2022 by Hannah Sachs-Wetstone

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 malaria report 2022, published last Thursday, found that progress in the fight against malaria has been steady, despite setbacks due to the COVID-19 pandemic. In order to strengthen the global response to malaria, investment is needed to close the funding gap and ensure money is available for the research and development (R&D) of new tools. There is a robust R&D pipeline of innovative technologies for malaria control including new long-lasting bednets, diagnostic tests, next-generation medicines, and other vaccines that will be essential to address the growing challenges of antimicrobial resistance and the spread of the Anopheles stephensi malaria vector in urban areas.

Despite rising COVID-19 cases in the United States, no monoclonal antibodies treatments are available for use as the US Food and Drug Administration paused the emergency authorization for the last remaining antibody treatment developed by Eli Lilly because it is not as effective against newer variants. There are other medications aimed at preventing COVID-19 that are currently authorized, including Evusheld and Paxlovid, but these treatments may not be as effective against new variants and may not be available for everyone. New antiviral treatments are in development, including one drug developed by researchers at the Dana-Farber Cancer Institute and another by Shionogi, which has received emergency authorization in Japan.

The spread of Sudan ebolavirus in Uganda has slowed dramatically, raising questions about whether the trial testing vaccine efficacy that was expected to begin shortly can go on due to reduced numbers of potential participants. A cancelled trial would be considered by many a loss given the incredible amount of effort that has gone into securing the vaccines, permissions, and funding for the trial, as well as the interest in testing new vaccines that could be effective against Sudan ebolavirus. Looking forward, stockpiling experimental vaccines and pre-agreed trial protocols could ensure readiness for any future Sudan outbreaks.

Categories: Antimicrobial resistance, COVID-19, Diagnostics, Ebola, FDA, Malaria, Medicines, Research Roundup, Vaccines, WHO

About the author

Hannah Sachs-WetstoneGHTC

Hannah supports advocacy and communications activities and member coordination for GHTC. Her role includes developing and disseminating digital communications, tracking member and policy news, engaging coalition members, and organizing meetings and events.Prior to joining GHTC,...read more about this author

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Research Roundup: Antimalarial drug manufacturing, Vaccine access investment, Antibiotics for newborns

Written by Hannah Sachs-Wetstone / GHTC
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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.Last week, Medicines for Malaria Venture and the Africa Centres for Disease Control and Prevention (CDC) signed a memorandum of understanding for providing technical support to African manufacturers for the development of antimalarial drugs. The support is aimed at helping improve the quality of antimalarial products to meet World Health Organization’s (WHO’s) standards in order to increase the use of locally produced drugs and make them eligible for bulk procurement by global institutions, as well as to address the high burden of malaria on the continent. This effort is also part of a wider initiative to increase African manufacturing after COVID-19 uncovered the risks of the continent’s over-reliance on imported drugs. The Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) are investing US$30 million in Aspen Pharmacare Holdings Limited to support the manufacturing of routine and outbreak vaccines for Africa. Through a ten-year agreement with the Serum Institute of India, Aspen will use the investment to manufacture and distribute the routine Pneumococcal, Rotavirus, Polyvalent Meningococcal, and Hexavalent vaccines, as well as support technology-transfer activities and build regional vaccine manufacturing capacity for potential future outbreaks. The investment underlies a wider effort to ensure vaccine manufacturing capacity and supply of affordable vaccines on the continent. Joining a growing call for action in response to the increasing threat of antibiotic resistance, WHO recently published the Global antimicrobial resistance and use surveillance system (‎GLASS)‎ report: 2022, which identified a high level of antibiotic resistance in bacteria that can cause fatal bloodstream infections and an increasing level of resistance in bacteria that can cause common infections. The report echoes a wider concern about the need for the development of new antibiotics for newborn babies to address the up to 570,000 deaths and estimated three million cases of neonatal sepsis each year, many of which occur in the absence of effective antibiotics due to rising antimicrobial resistance.
US Food and Drug Administration/Michael J. Ermarth
December 5, 2022

Research Roundup: COVID-19 antibody therapies, "Disease x" plan, Sleeping sickness drug trial

Written by Hannah Sachs-Wetstone / GHTC
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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.Last week, the US Food and Drug Administration ended the emergency authorization for Eli Lilly’s bebtelovimab, due to new variants against which the treatment is ineffective. Prior to this, bebtelovimab was the only COVID-19 antibody therapy still cleared for use. This news comes after several other antibody therapies were also made ineffective by the growth of new subvariants. While there are other updated antibody therapies in development, they will likely not be authorized for some time. Other COVID-19 treatments, including Paxlovid and Remdesivir, remain available although limitations prevent their wide use. The Coalition for Epidemic Preparedness Innovations (CEPI) has published a new plan for the development of a vaccine for “Disease X,” a pathogen with pandemic potential that has yet been identified. The plan calls for a vaccine within 100 days of the release of its genetic sequence. It was developed in collaboration with international health bodies, vaccine producers, researchers, and regulatory authorities, and identifies steps and investments needed far in advance of the identification of a disease outbreak.New results from a small trial found that a single pill of acoziborole given to participants with sleeping sickness (human African trypanosomiasis) in the late stages of infection has a 95 percent success rate at 18 months posttreatment and a 100 percent success rate among participants with an early-to-intermediary infection. The study, carried out by the Drugs for Neglected Diseases initiative, identifies the dug as a safe, effective oral therapy with incredible strengths compared to the currently used treatment, fexinidazole, which has a lower efficacy rate, must be taken more often, and has several common side effects.