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Last week, the Serum Institute of India announced that it will manufacture a promising tuberculosis (TB) vaccine candidate in late-stage development under an agreement with the Gates Medical Research Institute (Gates MRI). The candidate, M72/AS01E, which is currently being evaluated in a late-stage clinical trial, was originally developed by GSK before being licensed to the Gates Foundation. It could become the first TB shot in more than 100 years if approved. The agreement aims to build up manufacturing capacity to ensure adequate supply of the vaccine for rapid, widespread scale-up in key communities, if it is eventually approved. The Gates MRI will transfer the technology and know-how to the Serum Institute, which will invest more than $100 million to scale up manufacturing capacity. A Phase 1 trial evaluating a potential fast-acting, single-dose malaria treatment found promising results, as the growing threat of resistance of the malaria parasite to first-line therapies has underscored the continuous need for new antimalarials. The trial, conducted by QIMR Berghofer in collaboration with UniSC Clinical Trials and sponsored by Medicines for Malaria Venture (MMV) and GSK, found that the novel drug MMV367/GSK3772701 rapidly killed malaria parasites and was generally well tolerated in infected volunteers, appearing to work by blocking two enzymes critical to the survival of the malaria parasite in red blood cells. The treatment candidate belongs to an entirely new class of antimalarials that work differently to existing treatments, making it less susceptible to resistance. It also has the potential to be administered as a single-dose therapy in the right combination with other anti-malaria compounds.A Phase 1 trial of a Bundibugyo ebolavirus vaccine candidate launched last week, making it the first vaccine candidate to enter clinical testing in the response to the ongoing outbreak in the Democratic Republic of Congo. The Coalition for Epidemic Preparedness Innovations (CEPI)-backed candidate was developed by University of Oxford scientists and uses the same viral vector platform as the Oxford/AstraZeneca COVID-19 vaccine. Since the early days of the outbreak, CEPI, the University of Oxford, and the Serum Institute have been working together to urgently advance the development of the investigational vaccine into clinical trials. The trial will be conducted in Oxford, United Kingdom among 50 healthy adults aged 18-55 years, evaluating the candidate’s safety and immune response. There are currently no approved vaccines or treatments for the virus. 

The Drugs for Neglected Diseases initiative (DNDi) and the Serum Institute of India have announced a new licensing agreement covering clinical testing and future access for a promising treatment for dengue, a fast-growing global disease threat. There is no specific treatment for dengue and control efforts currently rely on targeting the mosquito populations that carry the virus and deploying new vaccines, which have varying effectiveness in certain populations and haven’t achieved widespread coverage. The Serum Institute developed and optimized the monoclonal antibody treatment, finding promising safety and efficacy results in preclinical and Phase 1 and 2 trials, and is currently carrying out a Phase 3 clinical trial in India. Under the agreement, DNDi will lead a Phase 3 clinical trial set to begin early next year in dengue-endemic countries, including Malaysia, Thailand, and Brazil, and, if the treatment is successfully approved, DNDi will support affordable access in low- and middle-income countries.A new study published in The Lancet Infectious Diseases demonstrated promising results for an investigational vaccine candidate for Shigella sonnei, an important step toward developing a vaccine for the disease-causing bacteria. Shigella sonnei is one of the four species of Shigella, a highly contagious bacteria that infects tens of millions of people around the world, causing diarrheal disease. There are no licensed vaccines for any of the Shigella species, two of which, including S. sonnei, are becoming increasingly resistant to first-line antibiotics. The investigational vaccine provided high-level protection, an estimated vaccine efficacy of 89 percent, in a Phase 2 trial conducted among healthy adult participants at two US sites. The next step for researchers is to optimize the dose level and evaluate the vaccine in larger trials in high-burden settings that include children, who are among the most affected by shigellosis.Last week, the South Africa Medical Research Council and the Unit of Viral Evolution and Transmission at IRCCS Ospedale San Raffaele initiated a Phase 1 clinical trial to assess the safety and pharmacokinetic profile of a promising broadly neutralizing antibody (bnAbs) for eventual use to prevent HIV acquisition by infants and young children. bnAbs, a type of naturally occurring antibody that can neutralize multiple strains of HIV, are considered a promising approach in HIV research and could potentially be utilized in a long-acting option to protect infants from HIV transmission during breastfeeding, helping close critical gaps in HIV care options and access. IAVI and partners developed the bnAb from blood samples taken from adult participants living with HIV around the world; it was selected for further development following evidence of strong potency in preclinical trials. The trial will initially enroll 26 healthy adult volunteers to collect data on dose section, administration strategies, and safety to inform the planned infant trial. 

123456455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgJuly 13, 2026Filed electronically via Regulations.govDocket ID: OMB–2026–0034Re: Comments from the Global Health Technologies Coalition on “Regulation for Federal FinancialAssistance” - Proposed Revisions to 2 CFR Governing Federal Financial Assistance (91 Fed. Reg. 32198,May 29, 2026)Summary of Key Concerns & Recommendations to the Office of Management and Budget (OMB)Shift from Peer Review to Political ReviewOMB should preserve peer review as the primary basis for individual funding decisions and limitpolitical appointee involvement to broader strategic priority-setting, ensuring awards remaingrounded in scientific merit and expert evaluation.New and Undefined Risk Factors Enhance SubjectivityOMB should clarify and narrow disqualifying risk factors, particularly “memberships andaffiliations,” to ensure definitions are objective, consistently applied, and do not disadvantagequalified applicants engaged in legitimate scientific collaboration.Mid-lifecycle Termination Authority BroadensOMB should maintain the existing Uniform Guidance framework for suspension and terminationand avoid expanding discretionary termination authority that could disrupt long-term researchand reduce return on taxpayer investment, particularly in clinical and human subjects research.Limitations on International Collaboration and ComponentsOMB should preserve scientifically justified international research and foreign subawards byestablishing clear, stable criteria for covered foreign entities and ensuring that national securitydesignations are transparent, consistently applied, and not disruptive to ongoing researchpartnerships.Uncertainty Around Relevant Communications on Research FindingsOMB should maintain the current framework distinguishing lobbying from permissible scientificcommunication, ensuring researchers can continue sharing findings and technical expertise sothat taxpayer-funded research can be translated into policy and public health impact.Please refer to the full comment below for additional context and detailed explanations of theserecommendations.455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgAs members of the Global Health Technologies Coalition (GHTC)—a group of more than 50 nonprofitorganizations, academic institutions, and aligned businesses advancing the development of new drugs,vaccines, diagnostics, and other tools for global health—we submit these comments to the Office ofManagement and Budget (OMB) on the proposed rule amending 91 parts of Title 2 of the Code ofFederal Regulations. Given the scope of this rulemaking, which adds 52 new subsections and fullyrestates 375 sections across 456 regulatory provisions, our comments focus on the sections mostdirectly affecting the ability to carry out effective, safe, and efficient global health research anddevelopment across the federal enterprise.We are concerned that several provisions in this proposed rule could undermine long-term researchinvestments and weaken the conditions that enable scientific progress. We respectfully offer thesecomments to ensure OMB fully considers the cumulative impact these revisions could have on theUnited States’ ability to maintain its leadership in biomedical innovation, maximize the return ontaxpayer investment, and continue advancing research that improves health at home and around theworld, while still strengthening transparency, accountability, and oversight in a way that does notfundamentally alter how federal research awards are administered.Shift from Peer Review to Political Review§ 200.205(b) — Pre-issuance review by senior political appointeesFor decades, peer review has been the cornerstone of the federal research funding process, ensuringthat funding decisions are guided by scientific merit, feasibility, and potential impact. This expert drivenprocess has supported major advances in medicine, public health, and biomedical innovation whilereinforcing confidence that taxpayer dollars are allocated effectively based on scientific evidence andexpertise.Section 200.205(b) would introduce a greater role for political appointees in the award approvalprocess, undermining this confidence. Research funding decisions often require highly specializedknowledge of scientific methods, clinical design, and subject-matter context. Career scientists,physicians, and subject-matter experts are best positioned to assess these complex factors. Expandingpolitical involvement in these determinations introduces the risk that considerations beyond scientificmerit may influence outcomes, reducing consistency in this process and discouraging investment inareas of science perceived as more subject to shifting policy interpretation, despite their potential publichealth value.Our community has seen recent examples where post-peer review intervention has delayed ordisrupted otherwise strong public health projects. Even limited instances can create broaderuncertainty, as research and institutions adjust to less predictable funding criteria. Over time thisuncertainty may discourage investment in multi-year, long-term, complex or high-risk research areasand make it more difficult to attract and retain scientific talent, particularly among-early careerresearchers or those in specialized fields, in a global competitive marketplace.GHTC urges OMB to revise Section 200.205(b) to preserve peer review as the primary basis for individualfunding decisions, ensuring that award determinations remain grounded in scientific merit and theexpertise of career scientists to preserve confidence in the fairness, stability, and effectiveness of thefederal research funding system.455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgNew and Undefined Risk Factors Enhance Subjectivity§ 200.206(b)(2) — New disqualifying risk assessment factorsAssessing risk among potential recipients is an important part of responsible stewardship of federalfunds; however, the criteria used should be clearly defined, objective, and applied consistently. Severalof the proposed disqualifying factors in Section 200.206(b) raise concerns because they rely on broadconcepts that may be interpreted differently across agencies, individual decision-makers, oradministrations, creating uncertainty for applicants.GHTC is particularly concerned by the lack of clarity surrounding the proposed consideration of anapplicant's "memberships and affiliations." The rule does not clearly define what constitutes anaffiliation, how such relationships would be evaluated, or what standards agencies would use todetermine whether an organization engages in activities that raise public safety or national securityconcerns. Many researchers—particularly those working in global infectious disease, pandemicpreparedness, HIV/AIDS, and other areas of global public health—routinely collaborate across bordersand maintain professional affiliations with international research institutions, as well as withcommunity-based organizations serving historically underserved populations, as a necessary componentof their work. These partnerships are essential to conducting rigorous, relevant research and deliveringeffective public health interventions. Without clearer definitions and transparent criteria, theseprovisions could be interpreted inconsistently across agencies or over time, leaving applicants uncertainabout eligibility and raising concerns that subjective interpretations of an applicant’s internationalcollaborations, institutional partnerships, or community affiliations could inadvertently disadvantagequalified applications or influence funding decisions in ways not clearly tied to objective, merit-basedcriteria or legitimate security concerns.GHTC urges OMB to revise Section 200.206(b) to provide clear, objective definitions and consistentlyapplied standards for disqualifying risk factors—particularly regarding "memberships and affiliations"—to ensure that legitimate national security concerns are addressed without creating unnecessaryuncertainty or disadvantaging qualified applicants engaged in scientifically justified collaborations.Mid-lifecycle Termination Authority Broadens§ 200.340(a)(2) — Expanded discretionary termination authorityResearchers build infrastructure, hire personnel, establish partnerships, and design multi-year scientificprograms with the expectation that, barring scientific, safety, or compliance concerns, federally fundedprojects will be carried through to completion. While unexpected circumstances may occasionallywarrant early termination, Section 200.340(a)(2) introduces a broader level of discretion that createssignificant uncertainty for researchers and institutions undertaking long-term research anddevelopment.These concerns are particularly significant for research involving human subjects and clinical trials.Unlike many other forms of research, clinical trials rely on the voluntary participation of individuals whoassume personal risk and commit to carefully designed study protocols in pursuit of scientificadvancement. They also require years of planning, substantial financial investment, extensive regulatoryoversight, and coordination among research institutions, health systems, and community partners.Premature termination can compromise data integrity, reduce the scientific value of completed work,delay the development of new medical countermeasures, and require costly closeout activities thatfurther diminish the return on prior taxpayer investment. It may also undermine the trust of research455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgparticipants and partner institutions whose continued engagement is essential to future public healthresearch.While there will always be circumstances in which awards must be terminated because of participantsafety concerns, scientific misconduct, or recipient noncompliance, the proposed rule that grantsbroader termination authority across all awards does not distinguish between those involving humansubjects research and other forms of federally funded research, nor does it establish additionalconsiderations or safeguards for studies involving clinical trial participants.GHTC calls for OMB to maintain the existing framework for award suspension and termination under theUniform Guidance, which already provides agencies with robust tools to address performance,compliance, and stewardship concerns, rather than expanding discretionary termination authority inways that introduce unnecessary uncertainty into long-term research and development and reducedreturn on prior taxpayer investment.Limitations on International Collaboration and Components§ 200.202(e) — Domestic-first framework for R&D awards§ 200.220 — Prohibition on covered foreign collaborationsMany of the world’s most pressing infectious diseases do not respect borders, and the United Statescannot effectively prepare for or respond to emerging health threats without conducting researchwhere those diseases occur. International components of R&D awards enable scientists to studydiseases in the populations and environments where they are endemic, generating the evidence neededto develop effective vaccines, therapeutics, diagnostics, and other interventions that ultimately protectAmericans alongside people around the world. These investments also maximize the value of taxpayerdollars by supporting research in the settings where it can generate the most meaningful scientificevidence, strengthening preparedness before health threats reach US borders and reducing the need formore costly emergency responses.The framework proposed in Section 200.202(e) risks narrowing the scope of research in ways that maylimit insight into global health threats. For many longstanding and emerging infectious diseases, insightsinto transmission patterns, intervention strategies, and the evaluation of medical countermeasures canonly be generated through collaboration with international partners and research sites. Thesepartnerships should operate with appropriate oversight, transparency, and compliance with US laws andnational security requirements. However, restricting these collaborations may ultimately diminish thereturn on federal research investments by limiting opportunities to generate the evidence needed toinform prevention, preparedness, and response strategies that protect both US and global health.Section 200.220 raises related concerns by restricting collaborations involving "covered foreigncountries" and "covered foreign entities." While the proposed rule references existing national securityauthorities, it does not provide sufficient clarity regarding which lists will govern these determinations,how frequently those lists will be updated, how changes will be communicated to recipients, or howagencies will apply those changes to ongoing awards. Given that these lists and associated nationalsecurity designations can evolve over time, researchers and institutions may face significant uncertaintyin determining whether existing or prospective collaborations remain permissible throughout the life ofa multi-year project.455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgThe proposed rule also provides limited guidance regarding how affiliations with foreign entities will beevaluated in practice or whether exceptions may be available when international collaboration isscientifically necessary to achieve the objectives of a federally funded project. Not all foreign entitiespresent the same level of national security concern, yet the proposed framework does not clearlydistinguish among varying levels of risk or explain how agencies will balance legitimate securityconsiderations with the public health value of continued international research partnerships.Over time, uncertainty surrounding the scope of permissible international engagement and thedefinition of restricted entities may disincentivize participation in global research partnerships. Thiscould reduce the United States’ ability to maintain on-the-ground research presence in regions whereoutbreaks originate, limiting early detection and response capacity. In the context of global infectiousdisease threats, reduced engagement in these settings may inadvertently increase, not decrease,vulnerability to emerging health risks that cross borders.GHTC urges OMB to provide greater clarity regarding the standards governing international researchcollaborations, including the application of restrictions on covered foreign entities, while preserving theability for scientifically justified international research and foreign subawards to remain integralcomponents of federally funded research. The final rule should establish clear, predictable criteria andimplementation guidance that protect national security while enabling US researchers to maintain theinternational partnerships necessary to maximize taxpayer investments, strengthen global diseasesurveillance, and advance the scientific discoveries that safeguard public health at home and abroad.Uncertainty Around Relevant Communications on Research Findings§ 200.450 — Issue advocacy prohibition / communications restrictionsCommunicating research findings is an essential component of translating evidence into impact.Scientific discoveries achieve their greatest public benefit when researchers can share evidence, explainthe significance of findings, and inform decision-makers responsible for translating research into policyand practice. The revisions proposed in Section 200.450, that includes terms such as "issue advocacy,""public messaging," and communications that "promote or oppose a particular social, political, or publicpolicy position," are broad enough that recipients may struggle to distinguish between prohibitedadvocacy and allowable scientific communication.Greater clarity regarding the scope of these restrictions would help ensure that federally funded entitiescan continue communicating scientific evidence and technical expertise while remaining fully compliantwith longstanding prohibitions on lobbying. Preserving the ability to responsibly disseminate researchfindings and inform decision-making is critical to ensuring that taxpayer-funded research translates intoimproved public health policy, stronger preparedness, and better health outcomes.GHTC recommends that OMB maintain the existing framework around messaging by preserving thelongstanding distinction between prohibited lobbying activities and the responsible communication offederally funded research, while providing greater clarity where needed to ensure that taxpayerinvestments continue to translate into evidence-based policy maximizing public health benefit.Conclusion455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgIn considering these revisions, we encourage OMB to evaluate not only the intent and impact of eachindividual provision, but also the cumulative effect of implementing many significant changessimultaneously across the federal grantmaking framework. While each revision may be designed tostrengthen oversight, accountability, or alignment with administration priorities, together they riskintroducing a level of uncertainty that could fundamentally alter how research institutions, investigators,and partners engage with federally funded research and development.The United States has long benefited from a research ecosystem that balances strong oversight withscientific independence, rigorous accountability with flexibility, and domestic leadership with strategicinternational collaboration. Preserving that balance is essential to ensuring that taxpayer investmentscontinue to generate lifesaving discoveries, strengthen preparedness, and sustain America's leadershipin science and innovation.We appreciate OMB’s consideration of these comments and respectfully urge the agency to considerand revise the provisions outlined above before finalizing the rule. If implemented as proposed, theserevisions could discourage participation in federally funded research, disrupt critical collaborations, andslow the development of lifesaving technologies needed to address current and future healthchallenges. Oversight, accountability, and transparency can coexist with the stable and predictablefunding environment that research and development requires, provided that efforts to strengthenstewardship of federal funds do not come at the expense of the conditions that have made the USresearch enterprise a global model for decades.Please do not hesitate to contact GHTC’s US Policy and Advocacy Associate Amanda Reiling atareiling@ghtcoalition.org or GHTC’s Executive Director Dr. Kristie Mikus at kmikus@ghtcoalition.org ifyou have questions or need any additional information.Sincerely,Dr. Kristie Mikus, Executive Director of GHTC on behalf of the Global Health Technologies Coalition

On Thursday, the World Health Organization (WHO) announced the first patient enrollment in a critical clinical trial evaluating investigational antiviral therapies to treat Ebola caused by the Bundibugyo virus, as the worrying outbreak in the Democratic Republic of the Congo continues to grow. There are currently no approved treatments specifically for the Bundibugyo strain. The trial is supported by a range of multilateral, regional, national, and scientific partners and is being coordinated by the Institut National de Recherche Biomédicale, the Institute of Tropical Medicine and the University of Oxford. Two therapies, the monoclonal antibody MBP134 and remdesivir, which were selected by WHO technical advisors, are being evaluated for their ability to improve survival among patients, with the goal of saving lives and helping curb the spread of the current outbreak, as well as generating evidence to improve care for future outbreaks. A comprehensive review of COVID-19 mRNA vaccines published last week in The Lancet found that they are safe and effective, as skepticism around the safety and trustworthiness of the technology has persisted in recent years, while new research efforts have demonstrated the technology’s promise to address a range of priority disease and health challenges, including influenza and cancer. The researchers found that serious events are rare and the odds of them occurring were outweighed by significant protection against severe disease, hospitalization, and death. The researchers do acknowledge challenges with mRNA technology, including that they mRNA vaccines are not as effective at providing long-last immunity as they are at generating short-term responses and they have significant, expensive storage resource requirements, challenging access in low-resource areas. Sustained innovation and a commitment to improving access could help address these shortcomings and ensure the promise of mRNA technology is fully realized around the world.Early results from a new study published in Nature last week found that an investigational HIV vaccine demonstrated unprecedented success in primates in a preclinical trial. The vaccine, which was developed through a prolonged collaboration between scientists at La Jolla Institute for Immunology and Scripps Research, works by prompting the immune system to produce high numbers of broadly neutralizing antibodies, which are capable of neutralizing a wide range of strains of the virus and are recognized as a promising approach in the HIV vaccine development field. One of the challenges of developing a vaccine for HIV has been the genetic diversity of the virus, with various distinct strains circulating. People living with HIV naturally develop broadly neutralizing antibodies that can neutralize various strains but designing a vaccine that can induce them has proven to be a challenge for researchers.