Global Health Watch: EMA recommends LEN, whistleblower report on foreign aid freeze, changes in NIH policies and new CDC director

August 1, 2025

Last Friday – just after we published Global Health Watch – the European Medicines Agency recommended injectable lenacapavir for PrEP. This comes amid more political chaos this week that threatens delivery including, a surprise funding freeze and its reversal, a new whistleblower report on the unlawful foreign aid freeze, changes in NIH policies and continued dismantling of federal advisory boards. Read on.

European Medicines Agency Recommends Injectable Lenacapavir for PrEP

The European Medicines Agency (EMA) recommended approval of injectable lenacapavir (LEN) for PrEP across the European Union and globally just weeks after the US FDA granted approval and the WHO issued global guidelines. These regulatory endorsements reflect an accelerated process compared to previous PrEP products and demonstrate the urgency and promise of LEN, with potential to dramatically expand choice in prevention. This is just the second medicine simultaneously reviewed by the EMA for the EU market, under the centralized procedure, and non-EU countries, under the ‘EU-Medicines for all’ program (EU-M4all), and the eighteenth medicine receiving an EMA recommendation under EU-M4all. 

IMPLICATIONS: These milestones represent important steps to advance access to LEN, but much work still remains to be done to ensure LEN reaches those who need it most. Coordination on in-country registrations, financing and procurement, supply chains, health worker training, demand creation, and community-led delivery is needed. See AVAC’s Gears of Lenacapavir for PrEP Rollout plan, which outlines all the moving parts. Now is the time to ensure all of the gears actually begin to turn even faster.

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NIH Disruptions

The US National Institutes of Health (NIH) has proposed changes to how it funds research, which could dramatically reduce the number and amount of research grants in the future. The National Cancer Institute (NCI) confirmed it will reduce the number of new and competing research grants it funds, despite a stable budget, due to rising costs per grant. This is largely due to NIH’s growing reliance on a “multi-year funding” (MYF) model, which requires a larger portion of a grant’s total funding (typically 50%) to be paid in the first year. Although MYF can offer researchers more predictable funding over time, it also creates immediate budget pressures, as more money is tied up upfront. As a result, NIH institutes may be forced to fund fewer grants overall, turning down even top-ranked proposals. Additionally, NIH has signaled that many MYF grants will be limited to four years instead of the traditional five-year period typical of R01 awards. 

In addition, on Tuesday, the administration temporarily halted all NIH funding for research. They then released the funds later in the day. In response to the halt, US Senator Patty Murray (D-WA), Vice Chair of the Senate Appropriations Committee, wrote, “Instead of trying to destroy the NIH, which has long been the envy of the world, President Trump and [OMB Director] Russ Vought should study up on the Constitution, which makes clear they don’t get to decide for themselves that they are going to rip hopes of new treatments and cures away from patients across America.” 

IMPLICATIONS: This new MYF policy undermines the research pipeline by favoring shorter, lower-cost projects, freezing out innovative or large-scale efforts and reducing the long-term funding that research institutions rely on. These maneuvers by the administration bypass Congressional budget authority and could be formalized through additional rescissions.  

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Threats to the US Preventative Services Task Force

It has been reported that US Health Secretary, Robert F. Kennedy Jr. plans to dismiss the 16 members of the US Preventive Services Task Force (USPSTF), which recommends preventive services (including PrEP and cancer screenings) that must be covered by insurers. USPSTF’s decision to recommend HIV PrEP mandates that insurance companies cover it under the Affordable Care Act. The HHS said no final decision has been made, but initial reports cite ideological concerns as the reason for this potential action, similar to how Secretary Kennedy undermined the CDC’s Advisory Committee on Immunization Practices. In response to this reporting, the American Medical Association and 100+ health organizations are urging RFK Jr. to preserve the task force’s independence and evidence-based role. 

IMPLICATIONS: This potential dismissal follows RFK Jr.’s recent dismissal of CDC vaccine advisors and raises concerns for HIV prevention advocates, particularly regarding PrEP. Weakening or politicizing this panel could jeopardize access to HIV prevention and other products for Americans. This is another action undermining science-based decision-making. 

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USAID Whistleblower Shares Details on Termination of Foreign Assistance

A newly released memo by USAID whistleblower Andrea Capellán shares details on the administration’s unlawful termination of nearly all USAID foreign assistance funding. In the memo, Capellán, a senior contracting officer at USAID, describes a six-month period of silence, confusion, and legal violations as staff were ordered to cancel thousands of contracts without proper authority, documentation, or individualized review. These claims are contradictory to the administration’s defense of the process used to carry out the funding freeze. It confirms that terminations were carried out en masse, with some letters even addressed to “Miscellaneous Foreign Awardees,” and that Secretary of State Marco Rubio’s alleged contract reviews were never substantiated.  

IMPLICATIONS: This new account supports AVAC’s ongoing legal battle (see AVAC vs. Department of State) arguing that the foreign aid freeze is illegal. Capellán’s report underscores the need for accountability and urgent restoration of global health programs that were halted midstream.  

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New Director of US CDC Confirmed by Senate 

The US Senate confirmed long-time civil servant Susan Monarez as the new permanent Director of the Centers for Disease Control and Prevention (CDC). Monarez is the first CDC director without a medical degree in 70 years to take on this role. NPR reports that in her confirmation hearing, Monarez “walked a fine line between traditional public health perspectives and those of her boss, Secretary of Health and Human Services Robert F. Kennedy Jr., who has long questioned the safety of vaccines.” 

IMPLICATIONS: Monarez will play a critical role in shaping the CDC’s HIV, STI, and global health work. Her confirmation comes just weeks after mass layoffs across HHS, and as the agency navigates the administration’s directives to reduce contract spending and restructure research funding.  

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What We’re Reading

Resources

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PrEP Implementation — What’s worked and what are we learning

Join AVAC and the South-to-South Learning Network for a webinar exploring lessons from countries that have successfully scaled up oral PrEP and how to apply them to introduce and expand access to long-acting HIV prevention options like CAB, DVR, and LEN.

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