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GHTC welcomes the recent addition of a specific indicator to measure research and development (R&D) capacity in the third edition of the Joint External Evaluation (JEE) tool—the instrument countries use to evaluate their health preparedness capabilities and compliance with the International Health Regulations (IHR), which govern countries’ obligations in handling public health threats. This is a significant addition, as it marks the first time R&D capacity has been explicitly factored into the JEE as a key measure of a country’s health preparedness.  As we saw with the COVID-19 pandemic, the lack of regionally distributed R&D and manufacturing capacities contributed to gross inequities in the global response, as regions with the strongest ability to develop medical countermeasures prioritized access for their populations while others were left scrambling to try to build their capabilities in real time. GHTC has for many years been calling for measures of R&D readiness to be formally integrated into the IHR and JEE, and we are pleased to see our advocacy efforts have contributed to this important update. We believe that the revised tool, and its inclusion of R&D, will ultimately improve the quality of assessment of countries’ capacities for timely detection, prevention, and effective response to public health emergencies.While the incorporation of an R&D-specific indicator is an important first step toward strengthening R&D capacity globally, GHTC is disappointed that the update has not gone further in comprehensively measuring the multitude of capabilities that are part of R&D readiness. The R&D indicator metrics have an insufficient focus on product development, and don’t measure important elements such as clinical trial, pharmacovigilance, and manufacturing capacity for various types of medical countermeasures, and we would have liked to see those incorporated into the new R&D indicator or elevated somewhere within the updated tool. While there are other separate indicators for surveillance and laboratory systems, they don’t interlink enough to provide countries with a comprehensive understanding of their national R&D capacity.As countries move to utilize this updated tool, GHTC will continue to work with partners and leverage platforms like the Global Health Security Agenda to push for an even more comprehensive R&D capacity assessment and strive to build a more equity-driven framework for prevention and response to future pandemic threats.

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 Wednesday, the US Food and Drug Administration (FDA) authorized Novavax’s COVID-19 vaccine for individuals 18 and over, making it the fourth COVID-19 shot recommended by the agency for use in the United States. The Novavax vaccine is also the first authorized protein-based COVID-19 shot, which works by delivering a protein present on the virus’s service, along with a chemical adjuvant that spurs the immune system to recognize it. The new authorization is for a series of two shots, separated by three weeks; it does not cover use of the Novavax vaccine as a booster shot, which the agency will need to evaluate separately. The vaccine must still be recommended by the Centers for Disease Control and Prevention (CDC) before becoming widely available; the United States has acquired 3.2 million doses of the vaccine to be shipped to states once authorized by the CDC director.The National Institutes of Health has launched a clinical trial of an mRNA vaccine candidate to prevent Nipah virus infection, a zoonotic disease with no currently authorized vaccine or treatment. The phase 1 clinical trial will test an mRNA-based vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults. NIAID’s Pandemic Preparedness Plan, published earlier this year, established a framework to study viruses of pandemic potential, like Nipah, and prioritize research on prototype pathogens. The newly launched study is the first clinical trial to use the prototype pathogen approach since the plan’s publication.In a new report, the World Health Organization outlines the pipeline of bacterial vaccine candidates and emphasizes the urgent need to step up investment and research into vaccines that can help combat antimicrobial resistance (AMR). The analysis is the first to provide detailed analysis of the pipeline of vaccines with potential to address drug resistance from priority pathogens, identifying 61 vaccine candidates in various stages of clinical development and 94 candidates in preclinical development. While highlighting existing vaccines and the promising candidates in late-stage development, the report also notes a critical need to accelerate trials of vaccines to address AMR and makes a case for bolstered investment that can lead to increased global health equity.

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 Wednesday, the Stop TB Partnership launched a new global plan to end tuberculosis (TB) by 2030. The plan requires a total of $250 billion in funding, $40.2 billion of which would go toward accelerating the research and development of new TB diagnostics, medicines, and vaccines—including a specific goal of developing a new TB vaccine by 2025. There is currently only one licensed TB vaccine, which was approved more than 100 years ago and has limited benefit in adult populations. Several promising candidates are in clinical trials, including four in advanced stages of development, making it possible to have a new TB vaccine by 2025—if sufficient funding and political will is present to push things forward.A new, “all-in-one” vaccine showed early promise in protecting against a variety of coronaviruses, including COVID-19, SARS, and MERS, according to preclinical study results published last week. The mosaic-8 vaccine was able to train immune systems to recognize eight viruses at once in animal studies, demonstrating proof of concept for its ability to block a range of betacoronaviruses—the subgroup containing the virus that causes COVID-19. The Coalition for Epidemic Preparedness Innovations (CEPI) has pledged $30 million to begin clinical trials of the experimental vaccine in humans. The phase 1 trial will take place at Oxford University, which collaborated with the California Institute of Technology to develop the vaccine, and will likely take at least a year.Advances in science, in conjunction with rising investment in research, have led to the development of promising new treatment candidates for several neglected tropical diseases (NTDs) in recent years—though little progress has been made on the NTD subset of parasitic worm diseases. In a new study published last week, researchers outline these NTD research trends, noting that despite a long-standing lack of innovation in drugs for neglected diseases, partnerships between public, private, and nonprofit entities have enabled major progress in developing treatments for several target NTDs like leishmaniasis, Chagas disease, and sleeping sickness. This same progress has not been seen, however, among parasitic worm diseases like schistosomiasis, as research is often left at early stages. Bolstered drug discovery efforts focused on these diseases are needed in order to combat their high global prevalence, the researchers conclude.

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 Bank on Thursday approved the creation of a prevention, preparedness, and response financial intermediary fund, or FIF, intended to strengthen national, regional, and global capacities to prevent and prepare for future pandemics. The FIF will pool dedicated resources for pandemic preparedness and response, starting with initial pledges of $1.1 billion—though this represents only around 10 percent of the $10.5 billion the fund will need annually, according to the World Bank and World Health Organization (WHO). WHO will provide technical leadership for the FIF in close collaboration with the World Bank; the scope and structure of its operations and board, however, have not yet been determined. The FIF will also incentivize increased investments from countries, enhance partner coordination, and serve as a platform for advocacy.The US Food and Drug Administration is advising vaccine makes to reformulate their COVID-19 shots to target the BA.4 and BA.5 omicron subvariants, which now account for the majority of US infections and have been growing in prevalence globally, alongside the original strain of the virus. The updated recommendation, announced last week following a vote by a panel of outside experts, is meant to leave enough time for vaccine makers to adapt their formulas and manufacture updated shots to provide broader protection against the virus amid potential fall and winter booster campaigns. The newer forms of the shots will only be offered as boosters, while the primary series of shots will continue to use the original vaccines given their maintained effectiveness against severe outcomes of the virus.The National Institutes of Health has begun testing a universal influenza vaccine that could provide long-lasting protection against a wide range of seasonal flu viruses as well as those with pandemic potential. The vaccine candidate, BPL-1357, is composed of four strains of non-infectious, chemically inactivated, low-pathogenicity avian flu virus. The phase 1 trial, which follows successful preclinical studies, will evaluate BPL-1357 delivered both intranasally and intramuscularly for safety and ability to induce immune responses among up to 100 volunteers. With this new vaccine candidate, scientists are attempting to induce a comprehensive immune response closely mimicking immunity from natural flu infection, as opposed to focusing on inducing immunity to a single viral antigen.