Research Roundup: Brazil implements new malaria treatment, First drug trial for Congo fever, FDA approves RSV monoclonal antibody

Congressional negotiations are moving fast and furious as policymakers seek to reach an agreement to reauthorize must-pass legislation, known as the Pandemic and All-Hazards Preparedness Act (PAHPA), governing how the United States prepares for health threats. The latest 2019 reauthorization of the original 2006 law will expire on September 30, leaving legislators with a rapidly closing window to determine how national preparedness infrastructure should be reformed in the wake of the COVID-19 pandemic.Though this legislation has far-reaching implications for America’s entire preparedness architecture, most notably for global health research advocates, it authorizes the work of the Biomedical Advanced Research and Development Authority (BARDA), an agency charged with advancing the research and development (R&D) of medical countermeasures (MCMs) against health threats. BARDA was created via PAHPA in response to the 2001 anthrax attacks in the United States and in recognition of the need for the government to play a role in spurring R&D of tools for chemical, biological, radiological, and nuclear threats for which there is no commercial market. While historically, the agency has focused foremost on man-made bioterror threats, in the past decade, it has increasingly played a role in advancing vaccines, drugs, diagnostics, and other tools against naturally occurring global threats like Ebola, Zika, antimicrobial resistance (AMR), and COVID-19—for the latter, as one of the leaders of the US government’s Operation Warp Speed.While the COVID-19 pandemic underscored the unique value of BARDA’s R&D capabilities, it also brought the United States to a point of intense partisanship on issues of pandemic preparation and public health. These splits have plunged PAHPA—which has historically enjoyed an uncontroversial and bipartisan policymaking process—into a tense 2023 reauthorization cycle.Below we look at where negotiations stand in each chamber and where things could go from here.A bipartisan SenateOn the Senate side, the deliberations for a mostly clean reauthorization have gone relatively smoothly in the Health, Education, Labor, and Pensions (HELP) Committee. While an initial discussion draft released on July 3 reflected areas of disagreement between Chairman Bernie Sanders (I-VT)—who wanted to see the bill tackle drug pricing and supply chain challenges—and Ranking Member Bill Cassidy (R-LA) —who proposed changes to the priority review voucher (PRV) for MCMs—by the July 20 markup, the senators had worked out a bipartisan deal in the form of a managers amendment.The bill, which last week was approved to be reported out of committee, includes a comprise that would require drugmakers to alert the government of disruptions in the supply of drugs and pharmaceutical ingredients and a new government-directed study on policy solutions to delink drug prices from R&D costs in exchange for a straight five-year extension of the MCM PRV program. Importantly for global health research advocates, the bill also includes more expansive and explicit language directing BARDA to conduct R&D for known and as-yet-unknown pathogens with pandemic potential, as well as an amendment introduced by Sen. Hickenlooper (D-CO) to authorize the creation of a new US Food and Drug Administration (FDA) team tasked with reviewing MCMs for emerging pathogens—as was requested by FDA in their fiscal year 2024 priority letter. It is worth noting that the compromise forged between Sens. Sanders and Cassidy included new authorities for FDA that have been the cause of derision across the chamber on the House side.A partisan HouseIn the House, leading up to the Energy and Commerce (E&C) Committee’s July 19 markups, tensions remained heightened as Democrats and Republicans were still unable to reach bipartisan consensus on the two PAHPA bills introduced by Representative Richard Hudson (R-NC): H.R. 4421, the Preparing for All Hazards and Pathogens Reauthorization Act, which covers BARDA and its parent agency the Administration for Strategic Preparedness and Response (ASPR), and H.R. 4420, the Preparedness and Response Reauthorization Act, which proposes changes to the US Centers for Disease Control and Prevention (CDC). Rep. Hudson reportedly decided to split the House version of PAHPA into two bills to disentangle the more politicized portions of the bill, housed in H.R. 4420, from the ones with more consensus, housed in H.R. 4421.Both bills were approved last week to go to the floor of the House.Since the House’s preliminary June hearing on PAHPA at which Rep. Anna Eshoo (D-CA) announced that she had pulled her name from the legislation, Rep. Hudson’s PAHPA bills have advanced through the chamber on a purely partisan basis. Other vocal representatives, like E&C Committee Ranking Member Frank Pallone, Jr. (D-NJ), hammered Republicans for not including FDA authorities to address drug shortages in the scope of PAHPA. Unsatisfied with the Republicans’ response to their demands, House Democrats on the committee released their own version of PAHPA immediately before the July 19 markups. The Democrats’ draft bill includes provisions to strengthen CDC, increase funding for programs like the Strategic National Stockpile (SNS), and give FDA new authorities to mitigate drug shortages.This tension culminated in almost exclusively party-line votes approving 15 health policy-related bills that, among other provisions, would hamper CDC’s powers and, according to experts, underfund CDC, BARDA, SNS, and ASPR. In one small glimmer of good news, the Republican-led H.R. 4421 PAHPA bill, like its Senate counterpart, also included more expansive language directing BARDA’s research on emerging infectious diseases (EIDs).What now?For the first time, the House E&C Committee has sent PAHPA to the House floor on a partisan basis in striking contrast to the Senate HELP Committee’s mostly bipartisan process. Notably, House E&C Committee Chair Cathy McMorris Rodgers (R-WA) alluded to considering the Senate’s “more tailored approach to more FDA authorities” as a workable compromise, but only time will tell as the bills advance to the next stage in the process. If the current House and Senate versions of the bill receive the requisite votes to pass in each chamber, they will then be sent to the Conference Committee, where the differences must be reconciled, and the resulting bill will be sent back to the House and Senate floors for final votes.But with the partisan nature of the PAHPA bills in the House, the slim majority Republicans hold, and the difficult procedural hurdles in the Senate that have been used to hold up anything COVID-related, it could prove challenging for policymakers to reconcile around a bill capable of being passed in both chambers. The only sure thing is that this reauthorization process is unpredictable and at the whim of the current political climate.What is GHTC’s take?Earlier this year, GHTC put out a set of policy recommendations for the House and Senate to consider as they reauthorized PAHPA. Even though the process is not over, there are indications that some of our coalition’s priorities are represented in the draft bills from both the House and the Senate. As discussed, both bills contain explicit language highlighting the need for “advanced development and manufacturing of MCMs for viral families which have significant potential to cause a pandemic” and call out “emerging infectious diseases.” It is welcome news to see the bills specifically highlight the need for R&D for both known and as-yet-known, or Disease X, infectious disease threats.Additionally, the Hickenlooper amendment is also supported by GHTC since it would bolster FDA “activities to advance scientific research related to the development of tools, standards, and approaches to assess the safety, efficacy, quality, and performance of countermeasures.” The inclusion of both EID callouts and FDA’s fiscal year 2024 priorities are notable wins in a year marked by proposed funding cuts to global health programs.Of course, there are still areas of much-needed attention not fully addressed by the bills. The lack of boldness of either chambers’ bills can be attributed to the difficult fiscal environment Congress finds itself in—exemplified by the far more contentious appropriations bills that many believe are sending the United States on the path to a potential government shutdown. GHTC’s recommendations for Congress to create a dedicated EID funding line and authorize more money for AMR research at BARDA are not included in the bills—nor is there discussion on advancing the low-resource settings utility of BARDA products, inclusion of the Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act to incentivize AMR research, or provisions to give BARDA loan authorities.However, through our staff-level conversations on the Hill, the dial seems to be turning in a positive direction for these priorities. Especially in discussions on EID funding and AMR priorities (including PASTEUR), there is growing bipartisan agreement that these issues are important enough for standalone funding—just not in this specific PAHPA during this particularly difficult fiscal year. Whether or not PAHPA is the vehicle, we see tremendous strides in the Hill’s recognition of the issues central to GHTC and our future advocacy.

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 World Health Organization (WHO) prequalified the first conjugate vaccine to protect against the five dominant causes of meningococcal meningitis in Africa. The vaccine, MenFive, which was developed through a collaboration between the Serum Institute of India Private Limited and PATH, with financial support from the UK’s Foreign, Commonwealth, and Development Office, demonstrated a high level of safety and immunogenicity in extensive clinical studies in The Gambia, India, and Mali. WHO’s prequalification will allow MenFive to be procured by United Nations agencies and Gavi, offering a promising tool that could avert the annual outbreaks and epidemics in the African countries with the most meningitis cases and deaths.A multisite phase 1 HIV vaccine clinical trial carried out by the Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership concluded with preliminary analysis demonstrating strong results. The novel mosaic HIV vaccine candidate, HIVconsvX, demonstrated the ability to trigger a strong and specific immune response that targets a broad range of HIV-1 variants, making it potentially applicable for HIV strains around the world. Researchers say it also represents an innovative approach within a pipeline of vaccine candidates that needs to be diverse to maximize the chances of success. The full reporting of the primary findings from the trial is expected later this year followed by further in-depth analysis.Last week, a joint statement from the United Nations Food and Agriculture Organization, WHO, and the World Organization for Animal Health warned that the H5N1 avian flu virus could adapt to more easily infect humans and urged multisector, international partnership and cooperation to protect both animal and human populations. The current H5N1 clade 2.3.4.4b has been circulating since 2020, causing unprecedented deaths around the world across different animal populations, especially in wild birds and increasingly, mammals. Although human cases have been only sporadic, maintaining and strengthening surveillance capability to be able to detect viral changes and human cases, as well as testing the currently circulating viruses for resistance to available antiviral drugs, will be essential to avoid further devastation.