Anna Kovacevich

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 Assembly (WHA) convened last week and concluded with several decisions affecting the global health architecture. The Assembly adopted a decision to bolster sustainable financing at the World Health Organization (WHO) by raising “assessed contributions,” or mandatory member fees, to cover 50 percent of the organization’s base budget by 2030, alongside steps to increase the agency’s efficiency. Proposals to immediately reform the International Health Regulations—which govern countries’ obligations to report and respond to pathogens that could lead to global public health emergencies—were not adopted due to member state disagreement, but the Assembly established an extended consultation process for future reforms and set a timeline for their implementation. Member states also discussed the ongoing negotiations around a pandemic instrument, which are being driven by an intergovernmental negotiating body formed last year, but any specific decisions will likely be at next year’s WHA at the earliest.Rising cases of monkeypox—confirmed in 19 countries since early May—have driven interest in the existing range of vaccines and treatments that could be used to offer protection against the outbreak. The monkeypox virus, which causes a usually mild infection, is closely related to the smallpox virus—and smallpox vaccines appear up to 85 percent effective in preventing monkeypox, according to WHO. There are two available smallpox vaccines: Bavarian Nordic’s Jynneos, also known as Imvamune or Imvanex, which has US approval for prevention of smallpox and monkeypox and European Union approval for smallpox but ability to be prescribed off-label for monkeypox, and Emergent Biosolutions’ ACAM2000, which has US approval for people at high risk for smallpox infection and no European Union authorization. While symptoms of monkeypox often resolve on their own within two to four weeks, there are also smallpox antivirals that may be considered for use.On Wednesday, Pfizer committed to provide its patented medicines and vaccines already available in the United States and Europe at a not-for-profit price to 45 lower-income countries. The deal, announced during last week’s World Economic Forum, includes 23 medicines and vaccines for infectious diseases, some cancers, and rare and inflammatory diseases, as well as future products. The initiative also includes Paxlovid, Pfizer’s oral antiviral treatment for COVID-19. Rwanda, Ghana, Malawi, Senegal, and Uganda are the first five countries to commit to join the accord, which will help inform rollout in all 27 low-income countries and 18 lower-middle-income countries that have transitioned from low to lower-middle-income classification in the past ten years. Pfizer says the initiative will be paired with improvements in diagnostics capacity and distribution infrastructure to improve access, as well as technical assistance for health worker training and expedited regulatory processes for entry of the new medicines.

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. IAVI and Moderna are preparing to launch the first in-Africa trial for an mRNA HIV vaccine candidate, the organizations announced last week. The phase 1 vaccine trial will take place at the Center for Family Health Research in Kigali, Rwanda, and The Aurum Institute in Tembisa, South Africa. The vaccine candidate, mRNA-1644, uses Moderna’s mRNA technology to deliver a specific class of B cells needed to develop broadly neutralizing antibodies to fight HIV infection. mRNA technology could accelerate the development of a safe, effective, affordable, and durable HIV vaccine, according to IAVI, and the trial will build on progress in HIV vaccine research using the combination of Moderna's proven mRNA vaccine technology and a novel HIV vaccine approach developed by IAVI and Scripps Research, and draw on more than two decades of collaboration with scientific centers of excellence in sub-Saharan Africa, supported by the US Agency for International Development.A US Centers for Disease Control and Prevention (CDC) advisory panel on Thursday voted to recommend children between the age of 5 and 11 should be offered a third dose of the Pfizer-BioNTech COVID-19 vaccine at least five months after receiving their second dose. CDC Director Dr. Rochelle Walensky then endorsed the panel’s recommendation, which followed authorization by the Food and Drug Administration earlier that week. In making their decision, the CDC advisors reviewed data indicating a third dose increases the antibody response from the vaccine, which should protect recipients better, at least temporarily. CDC also now recommends those who are 12 and older and immunocompromised and all people over the age of 50 should receive a second booster, at least four months after their first dose.Clinical research in the United States faces a “critical shortcoming” when it comes to diversity, a new report from the National Academies of Science, Engineering, and Medicine stresses. While diversity has become an increasingly important priority, racial and ethnic minority populations continue to be left behind in research, leaving a large portion of the US population—and those that often face the greatest health challenges—less able to benefit from discoveries, because they are not adequately represented in clinical studies. Members of the LGBTQIA+ community, older adults, pregnant and lactating individuals, and people with disabilities are also among the populations frequently left out. The report offers recommendations to increase the inclusion of these groups in order to advance equitable research—described as a clinical trial population that matches the demographics of the disease being studied.

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. World leaders convened virtually Thursday for a second Global COVID-19 Summit to accelerate collective efforts in the global pandemic response, pledging about $3.1 billion in new 2022 funding along with commitments to bolster availability of COVID-19 tools. The funding commitments, though falling short of the goal of $10 billion for vaccinations and $3 billion for therapeutics and oxygen, included more than $2 billion in funding for the immediate COVID-19 response and $962 million for a new pandemic preparedness and global health security fund to be established at the World Bank. The United States, which cohosted the summit alongside Belize, Germany, Indonesia, and Senegal, also announced a new National Institutes of Health licensing agreement to share technologies with the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool to support the development of therapeutics, early-stage vaccines, and diagnostic tools.The Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $19.3 million to support development of a “variant-proof” COVID-19 vaccine by an international consortium consisting of Bharat Biotech, the University of Sydney, and ExcellGene SA. The funding will support preclinical and clinical proof of concept for an adjuvanted subunit vaccine candidate—including immunogen design, preclinical studies, manufacturing process development, and a phase 1 clinical trial—with the goal of providing broad protection against all known SARS-CoV-2 variants of concern as well as future variants of the virus. The project could contribute to long-term control of COVID-19, according to CEPI, and the partnership has committed to achieving equitable access to any outputs of the project.A World Trade Organization (WTO) proposal to temporarily waive patent protections on COVID-19 vaccines is receiving tepid reactions from members ahead of a long-delayed ministerial conference set for June. The current compromise proposal would ease some existing barriers to issuing compulsory licenses for patents on COVID-19 vaccines, but also introduces new impediments, including a condition requiring countries to list each patent they intend to waive. The deal is a result of discussions between the European Union, United States, South Africa, and India, following the original proposal by South Africa and India presented in 2020, which sought to not only waive intellectual property protections on patents, but also trade secrets, copyrights, and industrial designs, for treatments, tests, and vaccines. WTO member states expressed mixed views at a recent meeting of the Council on Trade-Related Aspects of Intellectual Property, or TRIPS, ultimately leaving the fate of the proposal uncertain.

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. On Thursday, the US Senate confirmed Dr. John Nkengasong as US global AIDS coordinator to head the President's Emergency Plan for AIDS Relief, or PEPFAR. Dr. Nkengasong, a Cameroonian virologist who currently serves as director of the Africa Centres for Disease Control and Prevention (CDC), is the first person born on the African continent to take on the global AIDS coordinator role. President Joe Biden nominated him for the position last September, following a gap in permanent leadership since Dr. Deborah Birx departed in 2020. Prior to his position at Africa CDC, Dr. Nkengasong worked at PEPFAR on strengthening laboratory capacity across Africa. Africa CDC Deputy Director Dr. Ahmed Ogwell Ouma will head the agency in the interim while the African Union Commission selects a new director.The World Health Organization (WHO) last week released a rapid communication stating that patients 15 and older with multidrug-resistant tuberculosis (TB) or rifampicin-resistant TB can take a six-month, all-oral treatment regimen—comprising the drugs bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM)—instead of a regimen lasting nine months or longer. The guidance also indicates that patients with multidrug-resistant TB or rifampicin-resistant TB who have developed resistance to fluoroquinolones can subscribe to the same six-month treatment regimen, but without moxifloxacin—known as BPaL. WHO has previously recommended the BPaL and BPaLM treatment regimens, but only under operational research conditions; the new recommendation will allow programmatic implementation of treating almost all forms of drug-resistant TB with either of the shorter regimens.Two novel COVID-19 vaccine platforms—a plant-based coronavirus-like particle vaccine and a receptor-binding domain (RBD)–dimer-based vaccine—showed promising results, according to studies published last week based on phase 3 clinical trials. The two-dose, plant-based particle vaccine, developed by Medicago and GlaxoSmithKline, showed 69.5 percent efficacy against symptomatic COVID-19 caused by five variants identified in sequencing, and no severe cases or deaths were recorded. The RBD-dimer-based vaccine, developed by Anhui Zhifei Longcom, is a three-dose shot that showed 75.7 percent efficacy against infection and 87.6 percent efficacy against severe to critical disease. Neither vaccine requires extreme cold chain storage, which makes them appealing candidates for global COVID-19 vaccination efforts.

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. More newborn babies with sepsis are dying because their infections are not responding to the usual antibiotics, according to the largest global study on the subject to date. The study, sponsored by the Global Antibiotic Research and Development Partnership (GARDP), which enrolled 3,200 newborns diagnosed with sepsis in 11 countries, found that 11 percent of newborns died over the course of the study and that 15 percent were prescribed last-line antibiotics due to the high degree of resistance to standard recommended antibiotics in treatment units. Antibiotic resistance is now one of the major threats to newborn health globally, according to researchers, with virtually no studies underway to develop novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections. GARDP is now designing an interventional trial to identify better treatment regimens to combat rising resistance.World Health Organization (WHO) member states reached a preliminary agreement this week to gradually increase mandatory fees, or “assessed contributions,” to cover 50 percent of the organization’s core budget needs. WHO currently relies heavily on voluntary contributions and private donors, which can leave its financing inflexible and unpredictable. The new funding reforms would be contingent upon certain conditions, such as increased transparency, with the funding linked to a member state review of WHO progress on promised internal reforms. The agreement will still need to be formally approved by governments at the World Health Assembly in May to take effect.COVID-19 diagnostic testing has fallen by 70–90 percent around the world, making it increasingly difficult to monitor the pandemic’s evolution, treat patients, and track variants, according to FIND, a co-convener of the Access to COVID-19 Tools Accelerator diagnostics pillar. While reported cases and deaths are declining globally, changes in testing strategies and reductions in the number of tests being used globally means there is little confidence in actual case trends. The testing decline also undermines the ability to treat patients with new therapeutics—like Pfizer’s antiviral Paxlovid, which requires early diagnosis to get the most benefit—and has led to a decrease in the number of genomic sequences submitted to global databases, which helps track emerging variants.

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 combo flu and COVID-19 vaccine developed by Novavax elicits a strong immune response similar to stand-alone flu and COVID-19 shots, according to initial results of a phase 1/2 trial announced last week. The trial, conducted among 642 older adults between 50 to 70 years old in Australia, sought to identify an optimal dose of the vaccine using a modeling-based approach. The shot generated a similar immune response to both a stand-alone influenza vaccine as well as a stand-alone COVID-19 shot, and the modeling showed the combined formulation could reduce the total antigen amount by up to 50 percent, which could boost production and delivery. Novavax is launching a phase 3 study to continue evaluating the combination vaccine.BenevolentAI and the Drugs for Neglected Disease initiative (DNDi) have launched a joint research project to combat dengue, for which there is currently no effective treatment. The collaboration will use an AI-enhanced approach—using a data foundation developed from various independent data sources—to identify the underlying mechanisms involved in dengue infection and provide a host of potential biological targets and drug repurposing candidates that could help stop progression to severe dengue. Once the most promising drug candidates are identified, they will be evaluated in clinical trials in partnership with dengue-endemic countries. Applying cutting-edge AI technology to help neglected patients opens an exciting opportunity to rapidly identify and evaluate promising drug candidates, according to DNDi.The first open-air study of genetically engineered mosquitoes in the United States is now complete and shows promising results, according to biotechnology firm Oxitec, which is running the experiment. The experiment, launched in April 2021, involved releasing nearly 5 million engineered Aedes aegypti mosquitoes in the Florida Keys over the course of seven months. Oxitec’s engineered male mosquitoes carry a gene that is lethal to female offspring, causing the population to dwindle as each generation mates. While the experiment showed females did die as intended due to the gene, larger tests are still needed to determine whether the insects can achieve the ultimate goal of suppressing a wild population of potentially virus-carrying mosquitoes, and controlled clinical trials will be required to assess whether the method reduces transmission of dengue or other viruses carried by A. aegypti.