Breakthroughs Blog: CDC

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. IAVI and Moderna are preparing to launch the first in-Africa trial for an mRNA HIV vaccine candidate, the organizations announced last week. The phase 1 vaccine trial will take place at the Center for Family Health Research in Kigali, Rwanda, and The Aurum Institute in Tembisa, South Africa. The vaccine candidate, mRNA-1644, uses Moderna’s mRNA technology to deliver a specific class of B cells needed to develop broadly neutralizing antibodies to fight HIV infection. mRNA technology could accelerate the development of a safe, effective, affordable, and durable HIV vaccine, according to IAVI, and the trial will build on progress in HIV vaccine research using the combination of Moderna's proven mRNA vaccine technology and a novel HIV vaccine approach developed by IAVI and Scripps Research, and draw on more than two decades of collaboration with scientific centers of excellence in sub-Saharan Africa, supported by the US Agency for International Development.A US Centers for Disease Control and Prevention (CDC) advisory panel on Thursday voted to recommend children between the age of 5 and 11 should be offered a third dose of the Pfizer-BioNTech COVID-19 vaccine at least five months after receiving their second dose. CDC Director Dr. Rochelle Walensky then endorsed the panel’s recommendation, which followed authorization by the Food and Drug Administration earlier that week. In making their decision, the CDC advisors reviewed data indicating a third dose increases the antibody response from the vaccine, which should protect recipients better, at least temporarily. CDC also now recommends those who are 12 and older and immunocompromised and all people over the age of 50 should receive a second booster, at least four months after their first dose.Clinical research in the United States faces a “critical shortcoming” when it comes to diversity, a new report from the National Academies of Science, Engineering, and Medicine stresses. While diversity has become an increasingly important priority, racial and ethnic minority populations continue to be left behind in research, leaving a large portion of the US population—and those that often face the greatest health challenges—less able to benefit from discoveries, because they are not adequately represented in clinical studies. Members of the LGBTQIA+ community, older adults, pregnant and lactating individuals, and people with disabilities are also among the populations frequently left out. The report offers recommendations to increase the inclusion of these groups in order to advance equitable research—described as a clinical trial population that matches the demographics of the disease being studied.

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 Pfizer-BioNTech COVID-19 vaccine’s effectiveness among children ages 5 to 11 wanes over time but continues to protect against the most severe outcomes, according to new real-world evidence released last week. Analysis from the US Centers for Disease Control and Prevention, summarizing data from ten states, suggested that while vaccine effectiveness faded during omicron and generally decreases relative to the time since vaccination, the vaccine was protective against hospitalization and death in 5-to-17-year-olds, even after omicron emerged. A preprint study by the New York State Department of Health, also published last week, showed a substantial decline in protection among the younger age group in the state, including a significant decline in protection against hospitalizations. The new data comes amid developments involving vaccines for children under 5, which the US Food and Drug Administration plans to wait to review until data on third doses is available.The Biden administration plans to share government-backed COVID-19 technology with the World Health Organization (WHO) to help bolster access to medicines in low- and middle-income countries. The technologies, developed by the National Institutes of Health (NIH), would be licensed to the WHO’s COVID-19 Technology Access Pool as well as sublicensed through the United Nations-backed Medicines Patent Pool. Details on which technologies would be made available through the deal are still being determined, but the policy is not intended to apply to vaccines and therapeutics in the US market developed by private companies. Sharing NIH-devised technologies is meant to allow other countries to replicate the manufacturing process and therefore more quickly boost the global stockpile of pandemic supplies.On Wednesday, a WHO panel backed the use of Merck & Co., Inc.’s COVID-19 antiviral pill for high-risk patients. The recommendation, based on new data from six clinical trials involving 4,796 patients, conditionally endorses the pill, molnupiravir, for use among patients with non-severe disease who are at high risk of hospitalization. This could include immunocompromised individuals, the unvaccinated, older people, and those with chronic diseases. No recommendation has been made for use of the pill among patients with severe or critical illness, as there is no trial data for the group. The WHO panel is also preparing recommendations for Pfizer’s COVID-19 antiviral pill, Paxlovid.

Many experts have speculated that 2022 could bring the end of this acute stage of the COVID-19 pandemic. But if this proves true, what our new normal will be, and whether we’ll be better prepared for future crises, will depend on the decisions that our policymakers make in the months ahead. As 2022 begins, here are some of the top policy issues GHTC will be tracking.1. Will we achieve targets to vaccinate the world and what curveballs will COVID-19 still throw our way?What trajectory the pandemic will take in 2022 will depend in significant part on how successful efforts are to vaccinate the world. Last year, world leaders coalesced around a goal of vaccinating at least 70 percent of the world’s population by mid-2022, with an interim goal of vaccinating at least 40 percent of people in each country by the end of 2021. But a number of cascading challenges—from unexpected manufacturing disruptions with key suppliers to surging demand for booster shots in wealthy nations—slowed global efforts. As the year drew to a close, more than 90 countries missed the interim target, with many of the poorest nations in sub-Saharan Africa stuck at single digit vaccination rates. In a glimmer of positive news, the COVAX global vaccine facility delivered a record number of vaccine doses in December, hopefully setting a positive trend for the months ahead. Yet it remains clear there is much lost ground to make up as the year kicks off. Reaching the 70 percent target will require a significant influx of resources to boost manufacturing and overcome on-the-ground delivery and administration challenges, as well as continue research to respond to variants and deliver second generation vaccines better suited for distribution in low-resource settings. While leaders of the world’s richest nations have pledged their support for this global goal, few additional commitments of resources have materialized and nearly three-quarters of promised dose donations have yet to be shipped as of December. GHTC will be watching closely in 2022—particularly as President Joe Biden is expected to host a follow-up COVID-19 summit in March—to see whether the world embraces new urgency and accountability to close these gaps. As we’ve seen with the delta and omicron variants, COVID-19 could also still throw some unexpected curveballs our way that could upend existing efforts. 2. Will reams of recommendations turn into meaningful multilateral reforms?One might call 2021 the year of recommendations as several eminent groups, including the Global Preparedness Monitoring Board, the Independent Panel for Pandemic Preparedness and Response, and the G20 High Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response, issued reports recommending actions to reduce the world’s vulnerability to pandemic threats. This included several significant proposed reforms to the existing multilateral architecture, including establishing a new Global Health Threats Council to elevate preparedness to the highest level of political leadership, creating a new financial intermediary fund or financing facility at the World Bank to support countries in strengthening their preparedness capacity and to finance surge response during a crisis, making permanent a structure like the Access to COVID-19 Tools Accelerator (ACT-A) to support end-to-end product development for epidemic threats, and advancing a pandemic treaty or framework convention on health preparedness to reform or build upon existing International Health Regulations. Now it remains to be seen whether 2022 will turn into a year of action to make these reforms a reality. GHTC has long advocated that research and development (R&D) is an essential pillar of health preparedness. As these discussions advance, we will be monitoring closely to see how ACT-A evolves and pushing for any such international agreement or financial fund to support countries in strengthening their research and manufacturing capacity.3. Will the US COVID-19 spending spigot still flow in 2022?During the first year of the pandemic, policymakers in Congress seemed willing to throw unlimited money at the problem, passing a series of huge emergency spending bills to finance response efforts and cushion the pandemic’s reverberating economic impacts in the United States—though money for the international response was slower to arrive and lower than advocates and experts recommended. Now that we’re nearly two years into this crisis, many are asking whether Congress has hit pandemic spending fatigue or whether the spigot will still flow. The last major emergency supplemental funding package—the American Rescue Plan Act (ARPA)—was signed in March 2021, more than ten months ago. But the need for additional resources seems as acute as ever as 2022 begins. On the domestic front, omicron is overwhelming US hospital systems and fueling increased demand for tests and boosters, while on the global front, reports are the US Agency for International Development (USAID) is fast running out of resources, as it has already spent or earmarked most of the money it received through ARPA to support global vaccination and response efforts—just as a significant influx of vaccine doses are finally arriving in partner countries and the international response is entering its most operationally intensive phase yet.Political observers are now watching closely whether Congress will put together a new emergency funding package, possibly pairing it with the regular fiscal year (FY) 2022 spending bills that it must pass before the continuing resolution now funding the government expires on February 18. As these talks advance, global health advocates are pushing for any such package to include substantial resources to replenish the coffers of USAID, the State Department, and the Centers for Disease Control and Prevention (CDC) to lead the international response.4. How exactly will the United States build back better for global health innovation?While congressional policymakers spent 2021 largely in emergency response mode, as the new year begins, many are looking to the future of how we can strengthen US agency programs for health preparedness, as well as build upon the research successes and gaps illuminated by COVID-19. Several pieces of legislation are expected to advance this year, which could significantly transform our health innovation infrastructure.For example, the Senate Health, Education, Labor and Pensions Committee is formulating a new pandemic preparedness bill that will look at retooling and refining the capabilities of several Health and Human Services agencies, potentially including the Biomedical Advanced Research and Development Authority (BARDA). This federal agency, which is responsible for developing medical countermeasures against health threats, went from obscurity to a household name during the pandemic as it was entrusted with an influx of emergency funding more than 40 times its annual appropriated levels to advance COVID-19 vaccines, treatments, and tests. GHTC has long advocated for Congress to provide dedicated funding for BARDA to grow its R&D activities for naturally occurring health threats, including emerging infectious diseases (EIDs), antimicrobial resistance, and pandemic influenza. Much of the agency’s work on EIDs has been funded via unsustainable “boom and bust” cycles of emergency funding appropriated only after a crisis has begun. This pandemic preparedness legislation opens fresh opportunity for Congress to authorize such a permanent funding line to fuel sustainable, proactive preparedness research.Additionally, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) are advancing bipartisan legislation dubbed Cures 2.0, a follow-up to their 2016 21st Century Cures Act, which among other things would authorize a new Advanced Research Projects Agency for Health (ARPA-H). Modeled after the Defense Advanced Research Projects Agency, this new federal agency would seek to speed the development of medical innovations by funding high-risk, high-reward projects not likely to be advanced by traditional commercial research activities. Given this goal, the agency’s work could encompass research on poverty-related and neglected diseases, a recognized area of market failure. But at the moment, ARPA-H is more of rough concept than a fleshed-out proposal. As Cures 2.0 advances, much will need to be worked out as to what the agency’s research scope will actually include; whether it will be housed within the National Institutes of Health as President Biden has proposed or as a separate entity as some stakeholders have advocated for; and how much money congressional appropriators will be willing to pony up for this new unproven agency.Alongside these legislative efforts, GHTC has also recently unveiled a proposal for the creation of a new catalytic fund at USAID to drive global health innovation, called the Supporting Innovative Global Health Technologies (SIGHT) Fund. Such a fund would allow USAID to supercharge its existing work to advance inclusive innovations for low-resource settings, as well as reverse a declining trend in the agency’s spending on R&D as a proportion of its global health budget. As the year continues, GHTC will seek to advance this proposal with policymakers in Congress and the agency.5. Will calls to decolonize global health be codified into policy and practice?Calls to decolonize global health gained steam last year as the world bore witness to the gross inequities in access to COVID-19 vaccines and other tools between rich and poor nations, and here in the United States, the Black Lives Matter movement forced Americans to reckon with our nation’s history of racism past and present. While many leaders in the global health and development field now recognize the need to correct long-standing power imbalances rooted in the colonial era, individual organizations—from nongovernmental organizations to international institutions to development agencies—are grappling with how to translate this goal into policy and practice. Here in the United States, new USAID Administrator Samantha Power, in one of her first public addresses in November, laid out her vision for a new era of “inclusive development” at USAID. This included targets to direct at least a quarter of USAID funding to local partners within the next four years and by the end of the decade to have 50 percent of USAID programming have in place “local communities in the lead” who are responsible for codesigning, implementing, and evaluating programs. As 2022 continues, the global health community will be watching closely how Administrator Power’s vision leads to concrete changes in programs and practices at the agency.6. Will funding for other global health areas grow to match evolving needs?Much has been documented about how the COVID-19 pandemic has set back progress in other areas of global health, from disrupting routine immunization programs and reliable access to HIV and tuberculosis drugs to increasing the cost and complications of conducting research and clinical trials. The common refrain from health practitioners is that more resources are needed not just to respond directly to COVID-19, but to shore up other vital global health programs to protect fragile progress. Here in the United States, we’ll be watching whether congressional appropriators take this need to heart in 2022 as they finalize FY 2022 spending bills and begin work on FY 2023. Outside of programs focused on health security, most global health-related funding lines at the CDC, State Department, and USAID have been flat-funded in recent years, in practice decreasing their purchasing power as COVID-19 has only increased the cost of doing business. As every country worldwide is feeling the weight of the latest omicron-fueled surge, the first few days of 2022 have unfortunately felt much like “2020, two.” But as the year continues, it is our hope the pandemic will turn a corner and that policymakers will embrace lessons learned from this crisis to ultimately usher in a healthier, safer, and more equitable world for all.

President Joe Biden has made clear that addressing climate change is a top priority for his administration. Since January, the president has issued executive actions in pursuit of tackling the climate crisis; opened a new federal office for climate change, health, and equity; and convened two meetings of the Major Economies Forum on Energy and Climate, one of which was part of a larger leaders summit intended to rally world leaders to strengthen climate ambition in the lead-up to the 26th United Nations Climate Change Conference of the Parties (COP26) in early November, during which countries hope to negotiate shared climate commitments.Amid these ongoing and vital conversations, GHTC is taking stock of how global health and climate are intertwined and how innovation can address these twin issues and mitigate the impact of climate change on human health. As the Unites States prepares to engage in COP26, we hope to see continued commitments and concrete actions to combat the climate crisis, including climate-related global health challenges.Climate-related global health risksClimate and global health are inextricably linked: Climate change could put billions more people worldwide at risk of vector-borne and zoonotic diseases like malaria and dengue. Changing temperatures have been described as a “threat multiplier” of antimicrobial resistance, due to warm conditions being more favorable for bacterial reproduction. The climate crisis exacerbates food instability and malnutrition as a result of droughts and other extreme weather events—circumstances which also prove opportune for disease outbreaks. The threat of a “Disease X” outbreak occurring, and spreading globally, is greater than ever before due to deforestation and other climate-related risk factors.These risks will not be felt equally around the world. Children are among the most vulnerable—and will be exposed for the longest—to health risks resulting from climate change, given their physical and cognitive immaturity. Health effects are also expected to be worse for people who are older, have preexisting medical conditions, or are living in poverty or in low- and middle-income countries. These populations are less able to insulate themselves through technology, housing, social networks, health services, and other infrastructure. Food insecurity is likely to particularly affect Indigenous communities, many of which rely on local food sources, such as fish. Women and girls, too, are often underprioritized in responses to climate-induced disasters, which can inhibit their agency and access to sexual and reproductive health services, from contraception to HIV prevention and treatment.Existing efforts by US agenciesThe US government is beginning to recognize and take on the interconnected fight against climate change and global health crises through programs at the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and US Agency for International Development (USAID).For example, CDC’s Climate and Health Program assists states, cities, territories, and tribes in the United States with protecting human health from a changing climate by providing data, tools, and technical guidance to reduce vulnerability and increase resilience.NIH has launched a Working Group on Climate Change and Health aimed at addressing climate change and its health effects through research and innovation, and its National Institute of Environmental Health Services Climate Change and Human Health Program funds research aimed at understanding the health effects of climate change.USAID conducts a breadth of climate-related work, playing a crucial role in mitigating climate change and supporting resilience against its global impact—including by strengthening resilient food systems. USAID-supported programs have worked to develop and distribute disease-, heat-, and drought-tolerant seeds as well as nutrient-dense foods. For example, to support response to climate change–induced droughts and dry climates, USAID has invested in a public-private partnership to develop a variety of drought-tolerant maize, which was used by 6 million farmers in 2016 when the El Niño drought hit Southern and Eastern Africa.Looking ahead: What more should the US government do?In line with its expressed priorities, the US administration should continue to sustain and expand investment in climate change innovation—embracing a comprehensive agenda that recognizes the need to not only directly improve climate health, but also mitigate its impact on human health. While US health agencies have demonstrated some capacity to take on climate action for health, there is much more to be done.US agencies addressing climate change should consistently consider its ripple effect on global health and integrate a broad range of health-related climate innovation into their work—for instance, through emerging infectious disease surveillance, health and environmental systems capacity strengthening, or research to further understand both threats and the ways they interact.We will never achieve global health goals without also protecting our environment, and we won’t succeed in preventing the climate crisis’s worst impacts without bolstering investments in global health. GHTC looks forward to seeing continued commitment and global leadership from the US government to advance innovation to address these deeply intertwined challenges.