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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 World Health Organization (WHO) recently added Indian company Hetero’s generic version of Paxlovid (Pfizer’s COVID-19 antiviral) to its prequalification list. Hetero also announced a licensing agreement with the Medicines Patent Pool to manufacture and sell the generic version in low- and middle-income countries. WHO’s inclusion will hopefully improve access for the drug, which the agency has strongly recommended for the treatment of high-risk patients with mild and moderate COVID-19, but which has been largely inaccessible to patients in low- and middle-income countries.Recent findings published in the New England Journal of Medicine found that initial results from two phase 2 clinical trials showed that two vaccines (Ad26.ZEBOV (Ad26) followed by MVA-BN-Filo (MVA) 56 days later and rVSVΔG-ZEBOV-GP (rVSV)) given with or without a booster dose 56 days later) against the Zaire strain of Ebola virus are safe and well-tolerated in adults and children. Both vaccines produced antibody responses as soon as two weeks after administration of the first dose that lasted for at least a year. As part of the PREVAC study in West Africa, these trials aim to assess the safety and efficacy of different experimental vaccine regimens for Ebola Zaire vaccines in order to reduce the high mortality associated with Zaire outbreaks.An innovative, new vaccine for HIV developed by the Scripps Research Institute in collaboration with the Fred Hutchinson Cancer Center, the International AIDS Vaccine Initiative, and the US Institute of Allergies and Infectious Diseases, among others, has demonstrated promising results in its first immunogenicity trial in humans. In response to HIV exposure, the vaccine, called eOD-GT8, is designed to induce a type of broadly neutralizing antibodies that can block a specific part of the virus that is needed for it to enter certain cells. While extensive further research and many further challenges remain, the recent results do demonstrate the potential of a complex and innovative approach.

On Friday, President Joe Biden signed into law a US$1.7 trillion spending bill that will fund the US government through fiscal year 2023 (FY23), which ends September 30, 2023. The package includes significant funding increases across nearly every line relevant to global health research and development (R&D), as well as complementary directives that will support global health R&D across several agencies.How it passedUntil mid-December, the outcome of the spending package was still uncertain. Many Republicans in the House and some in the Senate were hoping to see a continuing resolution—a stopgap measure to postpone negotiations—into next year when they would hold more leverage with control of the House. Top House appropriator Rosa DeLauro (D-CT) responded by threatening to only pass a full-year resolution if no progress was made. As talks froze, Democratic lawmakers turned up the tension forcing a breakthrough weekend negotiation in early December. A few more bumps laid in the way, especially in the Senate, where energy permitting reform and Title 42 amendments were set on the table but ultimately shoved away, clearing a last-minute path for passage.New fundingPassage of the bill is mostly great news for global health R&D. Nearly every funding line across the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), the US Agency for International Development (USAID), and the State Department relevant to the sector has increased. Some notably large increases include:A 10 percent increase for universal influenza vaccine research at the National Institute of Allergy and Infectious Diseases (NIAID).A 50 percent increase for the Advanced Research Projects Agency for Health (ARPA-H).A 10 percent increase for NIH’s Fogarty International Center.A 9 percent increase for CDC.A 7 percent increase for the CDC Center for Global Health.A 9 percent increase for the CDC National Center for Emerging and Zoonotic Infectious Diseases.A 21 percent increase for global tuberculosis programs at CDC.A 16 percent increase for Global Public Health Protection at CDC.A 26 percent increase for BARDA.A 28 percent increase for the Global Fund to Fight AIDS, Tuberculosis and Malaria.A 7 percent increase to USAID global health programs, of which most goes to a 29 percent increase for global health security at USAID.New directivesIn addition to funding, spending bills are passed with corresponding plain-language texts called bill reports. which include directives from Congress. These reports do not hold the same legal power as the spending bills themselves, but they are a way for Congress to urge or direct agencies to change their policies or to spend their funding in specific ways. Nearly all GHTC’s requests for report language to Congress were reflected in the final FY23 package (either through the House bill reports or the joint explanatory statements, for those keeping count). Some notable wins include:Direction for USAID to increase health-related R&D funding and to consult with representatives of affected communities, as well as technical experts and nongovernmental organizations specializing in biomedical product development (House report).General continued support for USAID’s role in health-related R&D (House report).Requirement for USAID to submit a report on its health-related R&D investments (joint explanatory statement; also includes request for details on investment in antibiotic research).Request for an update from the Department of Health and Human Services on coordinating global health research activities using metrics (House report).Recognition of the need to increase resources for NIH’s Fogarty International Center and expand their role in pandemic preparedness and health research capacity-building (House report).Support for CDC’s role in global health security and developing and validating new global health tools (House report).Support for BARDA to provide robust funding for emerging infectious diseases and naturally occurring threats to global health security and to account for the constraints of low-resource settings in the development of new products (joint explanatory statement).Urges BARDA to publicly and regularly report on pathogen-, product-, and project-level data for all its funding (House report and joint explanatory statement).Relevant RidersThis year’s package also included quite a few riders—bills less relevant to funding that were amended onto the omnibus package. Nearly all elements of the PREVENT Pandemics Act were attached, including:Authorization of ARPA-H as a new entity within NIH. Despite its technical placement under NIH, the accompanying report language encourages ARPA-H to be physically and culturally separated. The authorization includes prioritizing awards to entities that conduct their work in the United States (a provision that GHTC has opposed).Establishment of a NIAID-BARDA “multidisciplinary research program with research centers to advance the discovery and preclinical development of antivirals and other medical products to combat priority virus families.”Expansion of the FDA fast-track designation for new antimicrobials that are biologics.The bill also includes several amendments to the US Food and Drug Administration (FDA) that had been dropped from the FDA user fees negotiations earlier this year. These include:Requesting a Government Accountability Office report on nonprofit pharmaceutical organizations, including the “impact of such organizations on the development, availability, and cost of prescription drugs, and any challenges to manufacturing or other operations.”Establishes a pathway for accelerating the review of advanced manufacturing technologies that either combine or incorporate novel technologies or techniques for manufacturing drugs, biologics, or active pharmaceutical ingredients.Requires sponsors of new drugs and devices to submit diversity action plans for clinical trials (exceptions permitting).Requires FDA to convene wide stakeholder meetings to solicit input on “increasing the enrollment of historically underrepresented populations in clinical studies.”Requires FDA to submit a report to Congress on progress for diversity action plans in aggregate.Requires FDA to issue guidance on decentralized clinical studies for drugs and devices and “how to advance the use of flexible and novel clinical trial designs” to increase diversity of participants.Requires FDA to issue guidance on the use of digital health technologies in clinical trials.In summaryDespite the delay, GHTC applauds lawmakers for passing increased funding, smart report language, and riders that will strengthen global health security and medical product regulation. The FY23 omnibus package is a significant win for most global health and global health research programs. Many pundits predict that in the next Congress we are less likely to see similar funding increases given the split control. Regardless, GHTC looks forward to working with offices on both sides of the aisle to advance bipartisan priorities for global health R&D.

2022 has been a year of both formidable global health challenges and exciting innovations in research and development (R&D). In addition to the ongoing COVID-19 pandemic, the year saw alarming outbreaks of mpox (monkeypox) and Ebola. These crises further highlight the importance of building adequate capacity to prevent and respond to outbreaks and pandemics. Greater investment is urgently needed to ensure we have the global health technologies and R&D capacity to develop lifesaving, transformative innovations like the COVID-19 vaccines, and to address the resource and access gaps that exacerbate the worst effects of these outbreaks and diseases. With adequate investment and political will, breakthroughs are possible—and we have seen several this year.As the year comes to an end, GHTC reflects on a few of the global health innovation stories that shaped 2022.1. mRNA vaccine technology is being applied to existing and future pandemicsThe rapid development and dissemination of messenger RNA (mRNA) vaccines for COVID-19 has generated a wealth of data about the safety and efficacy of mRNA vaccine technology.   The Moderna and Pfizer/BioNTech mRNA COVID-19 vaccines have already saved millions of lives as new formulations continue to gain approval. Their success has also helped advance the clinical development of vaccines for other respiratory diseases including influenza and respiratory syncytial virus (RSV).Renewed interest and tremendous progress in the development of a universal flu vaccine can be connected to the rapid development of mRNA COVID-19 vaccines and an increased focus on pandemic preparedness. Recent results from an exciting trial investigating a universal mRNA vaccine for influenza showed that the vaccine reduced flu symptoms and deaths, although further testing in humans is needed to confirm its safety and efficacy.This year, we have seen exciting new uses of mRNA technology for a variety of infectious diseases—including those yet to surface. There has been either interest in or initiated clinical trials evaluating vaccines using mRNA technology for HIV, tuberculosis (TB), Nipah virus, malaria, and Ebola. Additionally, we have seen pandemic preparedness efforts harnessing mRNA technology take shape. This past year, Moderna announced an initiative to develop mRNA vaccines for emerging pathogens and the Coalition for Epidemic Preparedness Innovations announced an effort to build a mRNA vaccine library against Disease X (the next pathogen with epidemic or pandemic potential that has been yet to be identified).2. Africa continues to strengthen R&D capacitiesThis year has seen a series of accomplishments indicating the flourishing role of Africa in global health R&D efforts, particularly around pandemic preparedness. 2022 saw the decision to make the Africa Centres for Disease Control and Prevention a fully autonomous agency, giving it more authority to assess and respond to disease outbreaks on the continent.Additionally, in 2022, the South African Health Products Regulatory Authority was classified by the World Health Organization (WHO) as maturity level three (on the four-level scale), a step that recognizes the stability and reliability of the agency in ensuring the safety, quality, and effectiveness of vaccines. The South Africa mRNA hub, which was launched by WHO in 2021, despite challenges, has begun development of an mRNA vaccine for TB and is working on developing a local mRNA vaccine candidate for COVID-19.Universal Corporation Ltd, supported by Medicines for Malaria Venture and Unitaid, this year became the first African manufacturer to gain WHO prequalification of sulfadoxine-pyrimethamine, marketed as Wiwal, a malaria drug aimed at preventing malaria in pregnant individuals and infants.3. Urgency and awareness of antimicrobial resistance is on the riseAntimicrobial resistance (AMR) continues to grow as a global health security threat, and many new reports and studies this year have documented the alarming trend. A 2022 report from Global Research on Antimicrobial Resistance found that AMR has become a leading cause of death globally, with the most deaths directly linked to AMR in sub-Saharan Africa and South Asia. Another recent report from WHO echoed the severity and growing threat of AMR around the world.Two 2022 WHO reports aim to contribute to overall understanding of AMR and the need for investment in R&D of new tools to strengthen the global response to it. The first identifies, in the context of AMR, 61 bacterial vaccines in clinical development and 94 candidates in preclinical development, and the second, more recent report identifies priority fungal pathogens including critical pathogens like Cryptococcus neoformans, Candida auris, Aspergillus fumigatus and Candida albicans. Hopefully, the focus on and investment in new tools to address AMR continue into the next year.4. Beating back malaria with the rollout of RTS,S vaccine and additional malaria technologiesAfter last year’s approval of the RTS,S malaria vaccine, 2022 saw the beginning of the rollout of this groundbreaking technology. Malawi, Ghana, and Kenya initiated routine immunization programs that will hopefully play an important role in the global effort to eliminate malaria. This year, a University of Oxford research team also published promising results for a new malaria vaccine, R21. The developers say the vaccine can be produced for just a few dollars and that they expect it to be rolled out next year through a manufacturing deal for more than 100 million doses a year, in partnership with the Serum Institute of India.  A new “mosquito-grounding” insecticide, Chlorfenapyr, that causes mosquitos’ wings to spasm and wither could also bolster the fight against malaria, according to trial results published earlier this year. Insecticide-treated bednets have been central in efforts to reduce the spread of malaria, but rising insecticide resistance among mosquitos has hampered progress, and Chlorfenapyr is the first new insecticide to be deemed safe and effective in about 40 years.Finally, this year, Australian regulators approved a simple drug combination as an effective cure for children ages 2 to 16 with Plasmodium vivax malaria, adding a new tool in the battle against the disease and opening the door to approval in other countries. The drug—tafenoquine, developed by GlaxoSmithKline and the Medicines for Malaria Venture—is a single-dose treatment administered alongside traditional chloroquine treatment.Due in part to previous innovations in antimalaria tools, progress against malaria has largely held in recent years, despite disruption from the COVID-19 pandemic. These next generation tools will be key to accelerating progress over the coming years.5. Outbreaks of mpox trigger innovation in developing treatments and vaccinesRising cases of mpox in the first half of 2022 drove interest in an existing range of vaccines and treatments with the potential to offer protection against the outbreak. The mpox 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 mpox, according to WHO. The National Institute of Allergy and Infectious Diseases and the Democratic Republic of the Congo’s National Institute for Biomedical Research are co-leading a clinical trial evaluating the safety and efficacy of the antiviral drug, tecovirimat (TPOXX) in adults with monkeypox. SIGA Technologies, Inc.’s TPOXX is approved for the treatment of smallpox in the United States.Facing low supply of Jynneos, the only vaccine approved for use against monkeypox in the United States, the US National Institutes of Health launched a clinical trial to test an alternative vaccine administration method to stretch the limited supply. The dose-sparing method involves giving two doses, each one-fifth of a full dose and administered intradermally.While monkeypox cases have diminished, these trials will provide essential data about the safety and efficacy of tools to address the disease that has long been neglected before this year’s outbreaks in high-income countries like the United States and the United Kingdom.6. Sudan Ebola outbreak prompts clinical trial and calls attention to gaps in outbreak preparednessOne of the most distressing developments of 2022 was the outbreak of the rare Sudan strain of the ebolavirus in Uganda. The response, however, advanced innovative approaches and highlighted the need for increased preparedness in the future.Following the identification of the outbreak, WHO announced a clinical trial of three experimental vaccine candidates to address the outbreak. The vaccines tested in the trial include one produced by IAVI, one developed by the Sabin Vaccine Institute, and a third developed by the Jenner institute at the University of Oxford. While the trial is expected to begin shortly, the spread of the Sudan ebolavirus in Uganda has slowed dramatically, raising questions whether the trial could continue. It is clear that despite the incredible amount of effort from various cross-sector global partners to secure the vaccines, permissions, and funding for the trial, responses to such outbreaks need to occur even quicker, which can be accomplished by developing stockpiles of experimental vaccines and pre-agreed trial protocols.7. Pretomanid and the BPaL regimen honored at GHTC’s annual awardsGHTC presented the 2022 Innovating for Impact Partnership Award to TB Alliance for the development of pretomanid and the BPaL regimen—an innovative treatment for drug-resistant DR-TB. Pretomanid, the first TB drug developed by a nonprofit organization, is part of the three-drug “BPaL” regimen. This innovative new therapy reduces the time needed to treat DR-TB from as long as 18 months or longer to 6 months and the number of pills comprising treatment by nearly 95 percent, all while significantly improving cure rates and toxicity profiles compared to the previous standards of care.This year, WHO updated guidelines for the treatment of drug-resistant TB to include pretomanid-containing regimens. Additionally, a study published in the New England Journal of Medicine showed that BPaL maintained efficacy with reduced dosage of linezolid, one of the drugs in the regimen. This is just one of the key tools that are essential to strengthen efforts against TB, especially as the recent 2022 Global TB Report reported that the number of TB and drug-resistant TB cases have risen for the first time in many years.For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2023 and beyond, sign-up now to receive GHTC’s R&D News Roundup newsletter.Image credits: PATH/Rocky Prajapati, PATH/Eric Becker, PATH/Christopher Nelson, PATH/Georgina Goodwin, PATH/Rocky Prajapati, PATH/Matthew Dakin

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.