News

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. In a new report, the US Department of Health and Human Services’ (HHS’) Office of the Inspector General (OIG) analyzed the US Food and Drug Administration’s (FDA’s) policies during the COVID-19 pandemic response and made recommendations for improving responses to future health emergencies. The report recognized several strong practices including the creation of templates for emergency use authorization (EUA) submissions and communication forums for the agency and developers. However, continual policy shifts and the decision to ease EUA requirements, possibly leading to the authorization of substandard assays, to increase the availability of COVID-19 tests were among the challenges identified. The report’s six recommendations include a revised device-tracking platform to facilitate the EUA submission process, formal communication channels with the lab community, and a national testing strategy.The messenger RNA (mRNA) hub, established last year in South Africa with support from the World Health Organization (WHO), began development of an mRNA vaccine for tuberculosis. The hub’s objective is to develop inoculations to address high-burden diseases in low- and middle-income countries. It is also working on developing a local mRNA vaccine candidate for COVID-19 (which will enter human trials in the coming months) after low- and middle-income countries faced major challenges accessing COVID-19 vaccines during the pandemic. The first approved mRNA vaccines were developed for the COVID-19 pandemic, but the technology has potential to accelerate vaccine development for other diseases as well, including tuberculosis.Last week, the government of Uganda declared an outbreak of a relatively rare strain of Ebola. The Sudan strain has not been reported globally in a decade and there is no approved vaccine to use against it. The rVSV-ZEBOV vaccine, or Ervebo, is currently used across Africa to limit the spread of Ebola outbreaks but it is only approved for the Zaire strain, which is responsible for the majority of outbreaks. However, WHO has pointed to a different Johnson & Johnson vaccine that has potential in targeting the Sudan strain, which could be confirmed through testing.

The first annual progress report on the American Pandemic Preparedness Plan (AP3), released earlier this month by the White House Office of Science and Technology Policy (OSTP), builds on the initial AP3 published by OSTP in September 2021 and frames global equity as a keystone of research and development for pandemic preparedness. GHTC applauds the report while acknowledging significant funding and political will are critical to achieving its objectives.The annual report’s emphasis on global equity in product development represents a significant and growing shift in the many plans, frameworks, and strategies issued by the US government to support pandemic preparedness over the past few years. It resonates, for example, with the recently released five-year strategic plan for the Biomedical Advanced Research and Development Authority that includes a greater focus on working with global partners and developing products for diverse populations living in different contexts.Early in the pandemic, the success of many research efforts was defined by the safety, effectiveness, and speed at which a product could be developed. Fortunately, those efforts led to safe and effective first-generation products that were quickly implemented in places with strong health care systems, such as Washington, DC, and Houston, Texas. What was missing, however, were safe and effective first-generation products that could easily meet the needs of people living in places where there are fewer resources, both in the United States and in many other countries. For example, in places with poorly funded health care systems, few highly trained health care workers, and limited refrigeration, it can be especially challenging to access, rapidly distribute, and administer millions of intramuscular vaccines that require ultracold storage.An important part of global health equity is developing products that are designed for and with the communities that will use them. This is true even in pandemic emergencies, and so GHTC advocates for pandemic preparedness research agendas to prioritize the needs of communities in low-resource settings. Safety, effectiveness, and speed are critical—but deliverability, availability, affordability, and ease of administration cannot be afterthoughts saved for the development of second- or third-generation tools.Some language in the AP3 annual progress report aligns with this vision. While the initial AP3 recognized that “vulnerable communities” face the greatest risk in public health emergencies and that the United States must work to strengthen global research systems and coordinate with global research partners, the new report goes further. Its executive summary states that “scientific and technological advances must be paired with public engagement, trust-building, and recognition and resolution of previous harms and challenges in public health.” The report goes on to recognize that for future responses, medical products need to be developed simultaneously with community engagement processes.Perhaps the most significant items in the new report are the key goals that weave in global health and the development of products that are designed for low-resource settings. The goals include:Exercising pandemic preparedness by “addressing infectious and global health challenges” such as influenza, antimicrobial resistance, and other infectious disease threats.Strengthening clinical trial networks and “warm base” research globally to develop next-generation vaccine technologies, therapeutics, and diagnostics, especially in “geographic regions most likely to see emergence of pathogens of pandemic potential.” Supporting diversified manufacturing for vaccines in low- and middle-income countries (LMICs).Developing vaccines that are easier to administer, more efficient to produce, and provoke a broader immune response. Strengthening national regulatory systems in LMICs to facilitate vaccine production. Supporting health care technologies that can be used at home and in remote locations. Developing a better understanding of global product manufacturing capacity and global investments to inform investments in essential medical product manufacturing in LMICs.Developing multiplex, “pathogen-flexible,” and “pathogen-agnostic” diagnostic tests and minimally invasive, simple-to-use diagnostic tests.It must be noted again, however, that although the AP3 annual report outlines laudable goals and provides a strong signal of White House priorities, for many of its goals to be achieved, Congress would need to provide additional funding and authorizations, which GHTC would support.Despite its limitations, the report is a step toward more equitable research agendas for product development and pandemic preparedness. Further US government commitments to such principles would go a long way toward ensuring that in future health crises, those in low-resource settings are not left behind and are able to quickly and equitably benefit from the development of new tools to protect and restore health.

The ability of women to choose whether, when, and how many children to have is essential to advancing the health and well-being of women and their families. In fact, research shows that expanding global access to contraception could reduce maternal deaths by nearly one-third and child deaths by one-quarter. Yet today, 218 million women in low- and middle-income countries have an unmet need for modern contraceptives. New contraceptive innovations are urgently needed to help close this contraceptive gap, including tools that are suitable and convenient for women who live far from health care settings and multipurpose products that combine contraception with HIV prevention. In recognition of World Contraception Day, GHTC is testing our readers’ knowledge of the history of contraceptive innovation. Your challenge for each question below: Name that contraceptive method.