Breakthroughs Blog: HHS

Last Wednesday, Emergent BioSolutions announced that it has received a $56 million contract extension with the Administration for Strategic Preparedness and Response to supply the US government with doses of a combined smallpox/mpox vaccine. The single-dose vaccine was first approved by the US Food and Drug Administration in 2007 for smallpox and, since 2024, has been one of two approved vaccines for smallpox and mpox. The vaccine doses, which will be stored in the Strategic National Stockpile, aim to boost US preparedness for future public health emergencies. A novel breakthrough method that utilizes artificial intelligence and advanced imaging technologies to more accurately and efficiently identify therapeutic antibodies could transform the way researchers develop treatments for infectious diseases, particularly emerging diseases, by significantly accelerating research. The method reduces the time needed to identify antibodies with potential from weeks to under a day and can also accomplish this task more efficiently, requiring far fewer researchers dedicating their time to screening thousands of candidate antibodies. This could allow researchers to move on from antibody discovery to the later stages of drug and vaccine development earlier and, ultimately, bring lifesaving products to patients faster. A recently published study found promising results for a new approach to developing broad-spectrum antivirals to treat existing viral infections and maybe even to prevent infections from emerging viral threats. Broad-spectrum antivirals are treatments that could combat a wide range of viruses by hitting essential targets that are common across many different viruses. While there are broad-spectrum treatments for bacterial infections, there has not been a similar broad-spectrum antiviral treatment approved for human use, in part because the proteins on the surface of a virus vary widely and change rapidly over time. The researchers focused on small molecules called synthetic carbohydrate receptors (SRCs), which earlier studies have suggested could be a potential target for antiviral medicines. They tested 57 different SRCs against six deadly viruses from three different viral families, including the viruses behind COVID-19, MERS, Nipah, and Ebola, finding several promising SRCs that blocked cells in the lab from being affected by all the viruses, some of which also later demonstrated promising safety and efficacy results in mice. 

On Thursday, Senate appropriators advanced out of committee a fiscal year (FY) 2026 spending bill for the Department of Health and Human Services (HHS) that rejects billions in health spending cuts proposed by the Trump Administration and protects programs vital to global health innovation.The bill increases or flat-funds global health research-relevant agencies, including the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA), and slightly reduces funding for the US Centers for Disease Control and Prevention (CDC) compared to FY25 enacted—an outcome that is in stark contrast to the President’s Budget Request (PBR), which proposed deep cuts across all three. Funding at this level will enable these agencies to continue to advance medical breakthroughs and operate programs that deliver better health outcomes for people around the world and fortify our defenses against disease threats.Funding highlightsThe legislation allocates $48.7 billion in funding for NIH, which is a $400 million (.8 percent) increase compared to FY25 enacted and nearly $22.2 billion (77 percent) above the PBR, and $1.015 billion for BARDA, which represents level funding from FY25 but $361 million (55 percent) more than the White House request. While the legislation unfortunately cuts funding for CDC by $72 million, or 1 percent, this allocation is $4.8 billion or 112 percent greater than the President’s request.While advocates expected the Senate to reject the steep cuts proposed by the Trump Administration, many still anticipated significant reductions. It is therefore both welcome and surprising that Senate appropriators advanced a spending package that maintains strong funding for many programs the President aimed to slash or eliminate.Beyond topline funding for agencies, the bill and accompanying report also diverge from the PBR in other crucial ways. While the President proposed eliminating the CDC Global Health Center (GHC), this spending bill keeps the center intact, maintaining level funding from FY25. The bill also maintains flat funding for the NIH Fogarty International Center—which supports global health research partnerships and training—and provides a 0.5 percent increase to the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). This stands in sharp contrast to the White House’s proposal to eliminate Fogarty entirely and cut NIAID’s budget by 58 percent. Additionally, it provides level funding to the Advanced Research Projects Agency for Health (ARPA-H), a new agency established under the Biden Administration to support high-risk, high-potential health research, rejecting the President’s proposal to reduce its funding by $555 million.Beyond  funding numbers, the bill’s accompanying report includes welcome directives affirming the Senate’s support for research activities critical to global health, including across health areas like neglected tropical diseases, malaria, tuberculosis, emerging infectious diseases, antimicrobial resistance (AMR), and more, and underscores the importance of international health research partnerships and training programs supported by the Fogarty International Center and global health activities undertaken by CDC GHC and NCEZID.  Taken together, the funding and directives can be viewed as a strong rebuke of the president’s efforts to downsize and dismantle US global health efforts and a strong affirmation of the Senate’s support for programs that save and improve lives around the world and protect Americans from disease threats. The report also dictates stricter reporting requirements to Congress for HHS, indicating bipartisan concern by lawmakers as to whether the agency is dispersing funding as directed and making scientifically-drive decisions.The report also conveys Senate appropriators’ desire to see BARDA devote robust funding to developing countermeasures against emerging infectious diseases, AMR, and pandemic influenza, and directs BARDA to spend no less than $10 million on advancing countermeasures against “Disease X,” which is a term to denote priority viral pathogens that could cause the next pandemic. Despite an overall positive picture, the bill does include some decreases to subaccounts relevant to global health, including an 80 percent cut to  the CDC-wide Infectious Disease Rapid Response Fund, which was a fund originally created to provide flexible funds for the agency to rapidly respond to pandemic and epidemic threats. See the chart below for a more detailed comparison of funding in the Senate bill and percent changes compared to FY25 enacted and the PBR.What comes nextThe bill’s passage out of committee is just an initial step in a lengthy political process. It will next go to the full Senate for a vote, the House of Representatives will need to advance its parallel bill, and then the two bills will need to be conferenced to work out their differences before going back to both chambers for a vote and then to the President for signature.It is anticipated that the House will propose lower spending levels for health programs than the Senate, so these numbers are a likely high watermark where negotiations begin between the two chambers. Nonetheless, if one reads the House’s spending bill on global health as a tea leaf of what’s to come, it’s unlikely the House will cut as deep as the President wishes , so if the two chambers can reach a compromise and pass a budget, we could see funding levels land somewhere below the Senate but still substantially above the PBR. In the House bill, we are likely to see stronger relative numbers for NIH over CDC, given heightened criticism for the latter agency among Republican lawmakers.For many advocates, this bill is welcome news that Congress is reasserting its power of the purse in opposition to the president, yet significant concerns remain. Will the two chambers actually reach a promising compromise? And even if Congress appropriates strong funding for FY26, given all the recent moves by the Administration to rescind, halt, or slow the disbursement of federal spending, will this money actually reach researchers and health implementers to deliver impact? While we can’t predict for certain, GHTC and other advocates will continue to keep a close watch on what’s to come and activate where we can in order to protect vital funding for global health and medical research. 

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, the US Department of Health and Human Services announced a $500 million investment into a vaccine project under a new initiative called Generation Gold Standard, which aims to advance universal influenza vaccines, hoping to get a vaccine into clinical trials next year and approved by 2029. The initiative, funding for which will come from the Biomedical Advanced Research and Development Authority, seems to be replacing Project NextGen, which had previously funded research into potential COVID-19 vaccines and treatments. Some experts and officials have expressed surprise at the direction of the initiative and the size of the investment.Scientists have discovered that a device used to diagnose bacterial meningitis in blood can also measure it in cerebrospinal fluid, helping speed accurate diagnosis and treatment of the illness, which is the most dangerous form of meningitis and a significant global health threat. The device has demonstrated high sensitivity in multiple cohorts of patients and it’s also affordable and delivers results within a half hour after spinal tap. The test was developed at an impressive speed, now available to patients within just a year of its discovery.Newly shared results from a clinical trial from the National Cancer Institute seem to confirm that a single dose of the vaccine used to prevent human papillomavirus (HPV) virus infection is just as effective as two, a finding that could transform efforts to reach the millions of children globally who are not getting vaccinated according to recommendations. Expanding HPV vaccination will also help reduce the global burden of cervical cancer deaths and deaths from other HPV cancers. While two doses are currently recommended, reducing the required dosage could make dissemination much easier and cheaper for many countries.

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 Wednesday, The New England Journal of Medicine published the full results of the PURPOSE 2 trial testing Gilead Science’s twice-yearly lenacapavir shot for HIV prevention, finding that it was extremely effective in a broad and geographically diverse range of cisgender men and gender-diverse people. These results follow those of the first PURPOSE trial published earlier this year, which found that the drug was 100 percent effective as a prevention option in a study of women and adolescent girls. Lenacapavir is already approved and available in several countries, including the United States, as an HIV treatment option. With additional approvals as an HIV prevention option, the shot could be a game-changer for many marginalized communities that face the highest risk of HIV infection.A recent study found that the investigational drug quabodepistat in combination with delamanid and bedaquiline demonstrated safety and efficacy as a treatment for pulmonary tuberculosis (TB). TB treatment has historically been months long and difficult to tolerate, leading to discontinued treatment courses that raise the risk of the emergence of drug resistance. This combination treatment could potentially help fill the gap for safer, shorter regimens that cause fewer side effects. Further large-scale and long-term trials will be needed to validate these findings before this treatment combination can be available to the communities that face the highest burden of TB.Last week, the US Department of Health and Human Services announced nearly $27 million to support the rapid development and scale-up of manufacturing capacity for diagnostic tests to address future biologic threats through the Biomedical Advanced Research and Development Authority consortium. The COVID-19 pandemic exposed the gap in the United States' capacity to quickly develop, validate, produce, and roll out diagnostic tests to curb the spread of an infectious disease outbreak. While the funding will specifically support the development of tests to detect Burkholderia pseudomallei, the bacterium that causes melioidosis, and Marburg virus, the aim is to advance diagnostics platforms that can be leveraged to quickly produce tests for other threats as they emerge.