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.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.

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.A study published last week found that an experimental influenza vaccine that uses messenger RNA (mRNA) technology protected against all known flu subtypes in animals. If found to be successful in humans, the universal vaccine, which would serve as a supplement to annual flu shots, could prepare the immune system to better respond to new flu viruses, reducing the likelihood of severe disease and death. These promising results come after years of efforts to develop a universal flu vaccine. While human trials are expected to begin soon, challenges including potential low tolerability of the mRNA vaccine will need to be addressed before the candidate can progress.A recently published study estimated that approximately 7.7 million people were killed by bacterial pathogens in 2019—the second leading cause of death globally that year. More than half of these deaths resulted from five pathogens: Staphylococcus aureus, Escherichia coli, Streptococcus pneumoniae, Klebsiella pneumoniae, and Pseudomonas aeruginosa. While the highest mortality rates occurred in sub-Saharan Africa, disproportionately high burdens are present throughout low- and middle-income countries, which could be linked to inadequate access to effective antimicrobials (which exist for all the bacteria investigated in the study), among other structural challenges. Despite the high burden of deaths associated with bacterial pathogens, they receive much less funding and attention compared to other diseases. These data underline the need for greater investment into a variety of interventions and innovations, including vaccine candidates, that can address drug-resistant bacterial pathogens.A recent study determined that an antibody (DH1017.IgM) found in pregnant women who were infected with Zika but did not pass the virus to their fetuses can protect mice from the virus and suppress it to an undetectable state in their blood. The study, which began during the 2015 Brazilian Zika outbreak, could lead to the use of the antibody as a therapeutic agent and prophylactic to protect at-risk patients during an outbreak. The research team is working next to discover whether the antibody can prevent transmission from pregnant mice to their offspring and hoping to progress to human trials that include pregnant individuals who are often excluded from drug trials. Preclinical research into other vaccine candidates for Zika are also underway.

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, Moderna announced that its new booster shot targeted at the omicron subvariant of COVID-19 raises immune protection against subvariants by increasing levels of omicron-blocking antibodies up to 15 times pre-booster levels. Moderna also said that an early analysis showed that while the antibodies generated by the booster were less effective against the rapidly growing BQ.1.1 subvariant, they could still block it. This announcement follows similar positive findings that were released by Pfizer and BioNTech earlier this month about their own bivalent coronavirus vaccine booster. However, Novavax also recently released results showing that their bivalent booster did not show a stronger response than their original booster.Last week, an analysis done by researchers from TB Alliance, Stop TB Partnership, and the World Health Organization estimated that the BPaLM/BPaL treatment regimen for drug-resistant tuberculosis (DR-TB) could save governments up to US$740 million a year. Implementation of the all-oral, shorter regimen is estimated to be 40 to 90 percent less expensive than current drug regimens for DR-TB, when accounting for drug costs, healthcare costs, and patient-incurred costs. The cost savings from the new regimen coupled with the shorter time period and the fewer drugs that are easier to tolerate, BPaLM/BPaL could contribute to more people with DR-TB having access to treatment and improved treatment experiences.Last week, the World Health Organization (WHO) announced that WHO and the Ugandan government are planning to test three candidate Ebola vaccines in a clinical trial with the intent to help address the ongoing outbreak in the country. The first doses are expected to arrive this week, although it is unclear when exactly the trial will start. The vaccines being used in the trial include one produced by IAVI, one developed by the Sabin Vaccine Institute, and a final developed by the Jenner institute at the University of Oxford. While there have been questions about the usefulness of the trial if it concludes after the outbreak ends, the results of the trials could provide essential information that will help prevent future Sudan Ebolavirus outbreaks even if it concludes after the current outbreak. Additionally, the trial design will enable all participants to receive a vaccine (though some will receive it after a delay) as opposed to a standard randomized controlled trial in which one group gets a placebo.

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 Coalition for Epidemic Preparedness Innovations (CEPI) announced plans for a US$1.76 million investment to advance and expand the scope and technology of the Spillover app, a platform created at the University of California, Davis that could be key to identifying and preparing for “Disease X,” a virus with pandemic potential that has yet to be identified. The platform includes a database with more than 500,000 samples from an estimated 74,000 animals in 28 different countries around the world, and CEPI’s investments will further its capabilities to identify viruses that are most likely to spill over to humans. The platform is hoping to use that data to prioritize and streamline investments in a library of vaccines, aimed at protecting against the viral families that pose the greatest threats, that are ready to be adapted against “Disease X” within 100 days of its identification.South Africa will begin piloting a new every-other-month HIV prevention shot as new modelling released last week showed that the shot could prevent as many as 52,000 new infections over the next 20 years if rolled out nationally. The pilot will begin after approval from the South African Health Products Regulatory Authority, which is expected early next year. Two large clinical trials found that the shot was more effective than the oral HIV prevention pill, Truvada, in part because it is taken much less frequently than the daily pill. However, the shot will only be available, at least in the short-term, in small pilot projects, and the high price is still a major barrier to the product being cost-effective in South Africa.Results from the STREAM clinical trial, shared last week at the Union World Conference at Lung Health showed that two shorter treatment regimens for multi-drug resistant tuberculosis (MDR-TB) including a fully oral nine-month bedaquiline-based regimen and a six-month injection-containing regimen have been shown to be safer and more effective that the nine-month regimen, which combines pills and injections, that is still in wide use. The STREAM trial was the largest-ever MDR-TB trial ever conducted with more than 1,000 participants across eight countries. The findings from the trial strengthen the evidence for bedaquiline as a component of improved drug-resistant therapies (bedaquiline is also a component of the six-month BPaL and BPaLM regimens, which were endorsed for use against most forms of drug-resistant tuberculosis in the World Health Organization's rapid communication on tuberculosis treatment guidelines released earlier this year).

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, Pfizer announced promising results from their late-stage clinical trial for an experimental vaccine candidate for respiratory syncytial virus (RSV), which has been causing serious concern in recent weeks. The vaccine was administered to pregnant individuals with the goal of protecting infants upon their birth. The trial found that the vaccine candidate was 82 percent effective against severe illness for infants in their first 90 days and 69 percent effective through their first six months. The Pfizer vaccine is one of several candidates that are expected to undergo review from the US Food and Drug Administration later this year.As the Ebola outbreak in Uganda continues, three experimental vaccine candidates aimed at protecting against the Sudan strain of the virus (for which there are no approved vaccines) have been sent to Uganda to be administered to people and to help generate more data for clinical trials. The candidates include one vaccine developed by Oxford University and manufactured by the Serum Institute, one developed by the National Institute of Allergy and Infectious Diseases and licensed to the Sabin Vaccine Institute, and one candidate from Merck. Doses of all three vaccines will be deployed to Uganda through a joint effort with the World Health Organization and the United States Centers for Disease Control and Prevention in the coming weeks and months.A new study conducted in Mali showed that a single dose of monoclonal antibodies provided protection from malaria infection for up to six months. While monoclonal antibodies are notoriously expensive to produce and complex to administrate, the lab-made antibodies employed in the study could prove to be a key tool to protect children and pregnant individuals in the fight against malaria, at least in the short-to-medium term. This study follows another last year, which showed that intravenous administration of the antibody prevented infection in all nine participants.