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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 ANTICOV clinical trial will begin testing a new drug combination, fluoxetine and budesonide, as an early treatment for people affected with mild-to-moderate COVID-19. ANTICOV—a multi-country trial consortium coordinated by the Drugs for Neglected Diseases initiative—aims to identify COVID-19 treatments optimized for use in resource-limited settings that can prevent progression to severe disease and potentially limit transmission. The new drug combination includes fluoxetine, better known by its brand name Prozac, and inhaled budesonide, a corticosteroid known to have potent anti-inflammatory efficacy in the lungs. Fluoxetine inhibits the ability of the virus to replicate by preventing viral entry into cells, while budesonide, if taken in an early stage of infection, improves recovery time in COVID-19 outpatients and may reduce hospitalizations and deaths, according to studies. Both drugs are commercially available, affordable, and easy to access and administer.Public Health Vaccines (PHV) has launched a phase 1 clinical trial to evaluate a single-dose vaccine against Nipah virus, for which there is currently no available treatment or vaccine. The PHV02 vaccine, originally developed at the National Institute of Allergy and Infectious Diseases, is being advanced by PHV with funding from the Coalition for Epidemic Preparedness Innovations to support development through phase 2 clinical trials. The phase 1 trial will evaluate the vaccine candidate’s safety, tolerability, and dose response in humans and determine whether humans mount antibodies to neutralize Nipah virus similar to those found to be protective against illness and death in several animal models. If trial results are favorable, PHV plans to initiate a phase 2 trial in a disease-endemic region in 2022.The Africa Centers for Disease Control and Prevention (CDC) will be elevated to the status of an autonomous public health agency for the continent instead of a technical arm of the African Union (AU), Africa CDC Director Dr. John Nkengasong announced last week at the 35th AU Summit. This development is a result of leaders’ renewed perception of disease as a security threat for the continent, according to Nkengasong, and signals growing member state commitment to strengthening the continent’s response to current and future disease outbreaks. The agency will now report directly to heads of state of AU member countries. The summit also included renewed calls for support of the African Medicines Agency treaty, which is now backed by 30 African countries, to set up a new regulatory body to facilitate improved access to medicines across the continent.

Ahead of the 6th Global Forum on TB Vaccines, GHTC joined call-to-action letters to European leaders calling for them to increase national investments in tuberculosis (TB) R&D, including TB vaccine R&D, in line with global fair share targets.

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 phase 3 trial to evaluate Valneva’s chikungunya vaccine candidate in adolescents has launched in Brazil, the company announced last week. The live-attenuated, single-shot vaccine, VLA1553, is currently the most clinically advanced chikungunya vaccine candidate worldwide, having completed phase 3 trials in adults. Valneva announced positive top-line results of the phase 3 trial in adults 18 and over in August 2021, indicating the vaccine induced protective chikungunya virus neutralizing antibody titers in 98.5 percent of trial participants and was well-tolerated across age groups. The recently launched trial, funded by the Coalition for Epidemic Preparedness Innovations, is designed to evaluate the vaccine in adolescents aged 12 to 17 and to support its extension to use in the younger age group following potential initial regulatory approval in adults from the US Food and Drug Administration (FDA).Healthy, young people who were intentionally exposed to SARS-CoV-2 developed mild symptoms, if any, in a first-of-its-kind COVID-19 human challenge study, according to a UK study of 34 individuals aged 18 to 30. Around half of the participants who received a low dose of virus became infected, some of whom had no symptoms, while others reported mild-to-moderate symptoms, including sore throats, runny noses, and loss of smell and taste. While controversial due to the risk to participants, challenge trials present an opportunity to study viral infections in detail­—and, according to scientists interviewed, the new study results show such trials can be done safely and lay the groundwork for more in-depth studies of vaccines, antivirals, and immune responses to SARS-CoV-2 infection.The HIV treatment Cabenuva has been approved by the FDA for use every two months, reducing treatments to only six times a year. The injectable treatment was first approved last year for use once a month, offering an alternative to antiretroviral regimens that require daily pills. The updated approval is based on data from a phase 3b study that showed dosing of Cabenuva every other month was non-inferior to monthly dosing and that rates of virologic suppression were similar for dosing monthly or every two months. Cabenuva is a combination of cabotegravir and rilpivirine, forming a complete regimen for HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.

As the world enters the third year of the COVID-19 pandemic, with new variants spreading around the globe and continued inequities in global vaccination and access to critical health tools, this year’s meeting of the World Health Organization (WHO) Executive Board (EB) felt like a make-or-break moment. Global leaders met to determine ways to not only address the current crisis, but also to build and strengthen the very institutions necessary to combat future health threats and reprioritize key programs and diseases that have fallen dangerously off track.  While some incremental progress was made, this year’s forum still left us with more questions than answers, with many key topics of concern remaining unaddressed, and more traditional dialogues related to research and development (R&D) for tuberculosis (TB), malaria, HIV/AIDS, or neglected tropical diseases (NTDs) receiving less airtime than at previous board meetings. Here are my top four takeaways from last week’s proceedings:EB disappoints on R&D topicsOne thing that has repeatedly been made clear at virtually every multilateral meeting in the past two years is that the pandemic has massively disrupted other critical health priorities, and that progress toward the Sustainable Development Goals and other key global targets is under threat. The EB continued the conversation on these challenges, including for TB research and innovation, NTDs, and the Immunization Agenda 2030. Yet despite a clear consensus that more must be done, few member states articulated specific changes that should be made immediately or presented new pledges to change the current trajectory in these key areas. Instead, many, including WHO, highlighted steps taken over the course of the past year, which, while welcome, are clearly nowhere near enough to even bring us back to pre-pandemic levels as we look to progress toward the Sustainable Development Goals. The disconnect seemed particularly striking during the TB session, in which members stressed the need to meet the 2018 United Nations high-level meeting TB R&D investment target of at least US$2 billion per year and address access barriers and other bottlenecks, while also acknowledging that annual funding for TB research needs to more than double to reach the global target, and provided no major recommendations on how to catalyze product development. It is also noteworthy that meeting logistics also played a part in the less robust debate. Due to time constraints, most agenda items were taken up in bundles, which forced all stakeholders to water down their statements and provided little opportunity to delve into the various recommendations presented in the reports and updates by WHO.Incremental progress on WHO’s work in health emergencies One area that continues to receive the bulk of the attention is WHO’s work in health emergencies. While the EB was not expected to finalize decisions on all the various reform recommendations that have been proposed over the course of the last year, significant progress was made in negotiations, opening the avenue for more concrete decisions to be made in the coming months.The EB took its first step in approving a process, introduced by the United States, to consider amendments to the International Health Regulations (IHR). The decision integrates this workstream into the mandate of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, positioning this forum as a platform for discussion and deliberation on ways to strengthen the existing IHR framework.The board also took steps to advance the formation of a standing committee under the EB on health emergencies. This committee, first proposed by Austria, would be designed to more closely oversee WHO’s emergency response efforts after a public health emergency of international concern is declared. Proponents argue that the goal is to coordinate a response within the EB, and that this new structure will not interfere with the IHR Emergency Committee. While some skepticism remains, member states were ultimately able to compromise to move the process forward.Dialogue on WHO financing stutters—but hope remainsAnother hotly anticipated topic was the item on sustainable financing. Although it was already clear coming into the EB that there is no consensus among member states on an increase in assessed contributions to WHO, it was nevertheless significant to witness many low- and middle-income countries expressing their support for WHO by showing their willingness to contribute more.Despite shouldering a massive burden as the global health multilateral institution, only a fraction of WHO’s financing comes through annual membership dues, leading to a lack of predictability and jeopardizing WHO’s independence and flexibility to carry out its mission. What’s more, an overreliance on heavily earmarked, voluntary, and short-term funding has left more than 25 percent of WHO’s staff on short-term contracts, further compromising its ability to meet its mandate.At the EB, the sustainable financing working group managed to win an extension of its mandate from the EB to continue discussions on these intractable issues until the World Health Assembly in May.The chair of the working group, Björn Kümmel, stated he would continue to push for consensus on the proposal, though he still faces some pushback from the United States, Brazil, and Japan, which cite their voluntary contributions, economic challenges, and WHO’s need for greater budgetary discipline and transparent governance as major considerations that should be considered in this process. The next few months will be a sprint to see whether an agreement can be reached going into the WHA with geopolitical speedbumps to be overcome along the way.Operational efficiency and non-state actor engagement remain challenges for WHOWHO’s finances were not the only existential concern that was thrown into sharp relief last week. As many officials and advocates slogged through the massive agenda, navigating the almost Kafkaesque processes of jumbling agenda items together haphazardly, one couldn’t help but wonder about the necessity of a major reset in how these meetings are run. In order to make it through the whole agenda, items that were tackled in the latter half of the week simply couldn’t be given their proper floor time. Many decisions were ultimately punted, and there was little practical debate. Much of the format remains archaic, with most of the updates and reports being simply text-heavy, and member states and non-state actors continue to have a difficult time picking up on key points or recommendations made by other participants. The engagement of non-state actors was also a topic of conversation, as several stakeholders called on member states to also prioritize interactions with civil society by actively participating in informal sessions and systematically sharing draft documents and resolutions to allow them to engage more robustly in policymaking and technical matters.After another whirlwind EB, member states now have the mammoth task of simultaneously advancing several initiatives, many overlapping, in the lead up to the World Health Assembly to secure the future of WHO and its status in the global health architecture and galvanize the world on the COVID-19 response.