Breakthroughs Blog: NIH

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.

Last Friday, President Joe Biden signed into law a $1.5 trillion spending bill that will fund the US government through the remainder of fiscal year 2022 (FY22), which began October 1, 2021, and concludes in September. The outcome followed months of tense negotiations by Congress—which had passed a series of temporary funding measures, known as continuing resolutions, to keep the government funded at FY21 levels since the start of this fiscal year—and last-minute maneuvering to try to pair annual spending with emergency aid for Ukraine and the COVID-19 response domestically and globally.While the bill ultimately included welcome boosts across key agency programs that fund global health and medical research, summarized below, in very disappointing news, emergency funding for COVID-19—including $4.5 billion for the global response—was stripped from the final package at the 11th hour due to disagreements on how to cover costs. This leaves an uncertain path ahead for the Biden administration to execute its COVID-19 plan, as previously appropriated funds for the domestic and global response are nearly depleted—raising the prospect of having to halt ongoing government-sponsored COVID-19 research trials, among other impacts. House Democrats have promised to advance a stand-alone COVID-19 emergency funding package, which could provide an influx of urgently needed funds, but it’s unclear whether such legislation could gain the 60 votes needed in the Senate since Republicans are demanding any new bill be paid for via offsets of unspent funds, a requirement many Democrats are opposed to.Below GHTC takes a detailed look at the spending bill and its impact on accounts that finance global health research and development (R&D) programming.State and Foreign OperationsThe final spending bill included $9.8 billion in funding for Global Health Programs at the State Department and US Agency for International Development (USAID), which represents an increase of $630 million, or 6.9 percent, over FY21 enacted levels. The vast majority—$510 million—of that increase is designated for global health security programming at USAID, a 268 percent increase over FY21 funding. This funding includes a $100 million allocation for the Coalition for Epidemic Preparedness Innovations (CEPI) to support vaccine development for potentially epidemic threats, which is both welcome news and higher than the $50 million pledge for this fiscal year announced by USAID Administrator Samantha Power at the CEPI pledging summit just a few days prior.Beyond global health security, the remainder of the increase—$130 million—was spread across other global health accounts. The tuberculosis and maternal and child health program lines at USAID received the largest increases at $52 million (16.3 percent) and $34.5 billion (4 percent) respectively, while nutrition, malaria, and neglected tropical diseases were each increased by $5 million and vulnerable children was increased by $2.5 million. USAID’s HIV/AIDS and family planning lines received flat funding compared to last fiscal year while the President’s Emergency Plan for AIDS Relief, or PEPFAR, under the State Department, was boosted by $20 million (0.5 percent). No global health-related accounts at USAID or State saw their funding cut. In other important news, in the joint explanatory statement accompanying the bill, Congress included language, for which GHTC advocated, directing USAID to develop and publicly release a new multi-year strategy on health R&D detailing its goals and how it plans to invest across health areas. USAID’s current health R&D strategy runs through 2022, so the fulfillment of this congressional directive will help ensure continuity and that research remains a priority for USAID’s global health programming.While it was positive to see Congress provide a major funding boost for health security programming and some modest increases to other global health accounts, overall, these funding increases fell short of what many advocates had hoped for, and in many cases what the House and Senate bill drafts released in 2021 had proposed. The COVID-19 pandemic has increased both the challenges and costs of operating health and research programs worldwide, so this funding package, even with increases, fails to match the scale of today’s expanding needs.Health and Human ServicesThe spending bill provided much larger, but uneven, increases across Department of Health and Human Services (HHS) subagencies and programs that support global health R&D. The National Institutes of Health (NIH) received $44.96 billion in funding, representing a $2 billion, or 4.7 percent, increase over FY21 levels. This included an increase of $253.1 million, or 4.2 percent, for the National Institute of Allergy and Infectious Diseases and a $2.8 million, or 3.4 percent, increase for the Fogarty International Center, which works to strengthen research capacity in low- and middle-income countries.Meanwhile, the Biomedical Advanced Research and Development Authority (BARDA)—an agency that supports development of medical countermeasures against health threats and a central player in COVID-19 R&D through then Operation Warp Speed—received a significant funding boost from Congress. It was appropriated $745 million in funding, a $148 million, or 24.9 percent, increase over the prior fiscal year. This funding envelope supports the agency’s entire research portfolio, which covers chemical, nuclear, radiological, and biological threats—both man-made and naturally occurring—so it is at the agency’s discretion to determine what of this funding it ultimately spends on R&D for naturally occurring health threats, including emerging infectious diseases, pandemic influenza, and antimicrobial resistance. Congress included in the bill’s accompanying joint explanatory statement language requested by GHTC expressing support for BARDA to expand its work on naturally occurring threats and provide more detailed reporting on such spending.The Centers for Disease Control and Prevention (CDC), which is a smaller but still important player in supporting global health R&D, received overall funding of $8.5 billion, a $582.4 million, or 7.4 percent, increase from the prior year. Within that, the Center for Global Health received a $54 million, or 9.1 percent, increase, with 93 percent of that increase designated for the global public health protection line focused on health security and the remainder spread across accounts funding global immunization, HIV/AIDS, tuberculosis, and parasitic diseases and malaria. The National Center for Emerging and Zoonotic Infectious Diseases, which funds select R&D for diagnostics and vaccines against infectious diseases, received a $45 million, or 6.9 percent, increase over FY21 enacted levels. These CDC increases were seen by many advocates as disappointing compared to evident needs. Challenges faced by the agency during the COVID-19 pandemic have underscored the need for a more significant influx of funding for this historically under-resourced agency to modernize its systems and improve staff retention.In addition to providing increases for the three HHS agencies above, Congress appropriated $1 billion for HHS to set up a new Advanced Research Projects Agency for Health, modeled after the Defense Advanced Research Projects Agency, to speed development of medical breakthroughs by funding high-risk, innovative projects. This funding was far lower than the $6.5 billion requested by the Biden administration and interestingly was designated to HHS to establish the agency under the Office of the HHS Secretary, rather than within NIH as the Biden administration and some congressional leaders had proposed. GHTC has pushed for this proposed agency to focus on poverty-related and neglected diseases, as a key area of market failure by industry; however, it remains unclear what health areas this new agency will initially prioritize as it is stood up.While FY22 was a bit of a mixed bag for global health R&D, with important increases across some programs but other areas falling short, advocates are already gearing up for the budget battle ahead for FY23, with the Biden administration expected to release its FY23 budget proposal soon.

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.