A shutdown of funding for the US Agency for International Development (USAID) could lead to the termination of clinical trials and longer development time of infectious disease drugs, a researcher has claimed.
On 24 January 2025, US Secretary of State Marco Rubio ordered a pause in all new obligations of foreign assistance funding through USAID pending an 85-day review, with further orders to contracting and grant officers to issue stop-work orders for all existing foreign assistance awards. These orders saw all USAID programmes suspended, including those with funds already obligated and disbursed.
There was an original waiver for “emergency food assistance” with a further waiver for existing “lifesaving humanitarian assistance” programmes, which the agency defined as “life-saving medicine, medical services, food, shelter, and subsistence assistance, as well as supplies and reasonable administrative costs as necessary”. It is unclear whether these provisions include research efforts. This comes after an executive order by President Donald Trump to withdraw the US from the World Health Organization (WHO), which experts also believe will impact global research efforts.
Established in 1961, USAID is used to fund various projects including clinical trials for vaccines and therapeutics in lower-middle-income countries, as well as elsewhere worldwide. The organisation has been used to find research into human immunodeficiency virus (HIV), tuberculosis (TB) and malaria, among other diseases and research efforts. The sudden pull of funding has meant trials have been suspended until trial sponsors seek alternative methods of funding to restart studies.
There have already been reports that companies, including non-profit vaccine developer International AIDS Vaccine Initiative (IAVI), have had to pause clinical trials due to the funding pull, luckily with no patients having yet been dosed. Other trials, including a study of a contraceptive medical device trial, have paused while patients who have had the devices implanted for the study are unclear as to whether their follow-up care will continue after the loss of funding, something that has been described as both unethical and dangerous.
Anna Roca, Professor of Epidemiology at the London School of Hygiene and Tropical Medicine’s Medical Research Council (MRC) Unit the Gambia, and Research Professor for the Catalan Institution for Research and Advanced Studies (ICREA) at ISGlobal, the Barcelona Institute for Global Health, said that the MRC has been affected by the funding pull and that the industry is currently unsure how to respond.
Abigail Beaney (AB): How will the pull of funding from USAID impact the research space?
Anna Roca (AR): It is difficult to predict what exactly is going to happen after the pulling of this funding because it depends on how other institutions or funding agencies respond to this. To me, there are two main things here – one is the stop of the funding of USAID, and the other is how it has happened. From one day to the other, everything has been closed which has created an immediate impact that is difficult to be mitigated by other institutions. The impact will be felt across several areas as USAID funding can have a crossover between research and global health, or public health in low- and middle-income countries.
One example is vaccines where there is a bit of an overlap because there is the funding that goes to the vaccine alliance GAVI that is used for both vaccine research and vaccine implementation and outreach. There are also programmes related to HIV, tuberculosis (TB) and malaria that are directly funded by USAID. Funding overlaps again between research and global health in these indications so the immediate loss of funding will have very quick implications for access. Patients will stop getting access to drugs which will impact the results of epidemiological research and health system research. It is also important to consider that if patients are already on treatment for HIV and suddenly this treatment stops, it is not only dangerous for the individual by putting them at a high risk of death, but it is also a risk to antimicrobial resistance. This is the same with malaria where there’s been improvements during the last decades, but this could hold all that improvement back.
AB: How will ongoing clinical trials that are partly funded by USAID contributions be impacted and are there resources to continue caring for participants in those affected studies?
AR: At the MSC unit, we have projects that had not officially started but we had already signed contracts and now we haven’t got that funding. We had already started putting things in place expecting this funding, including hiring people. While we have not started recruiting participants, some studies have and that creates a lot of ethical implications because when you are running a trial and recruiting a participant, you are obliged to follow the participant until a certain period. You need to be sure that the intervention is not harmful and dependent on the type of intervention, you have to follow them very closely, especially for a vaccine trial. The earlier the phase, the closer that follow-up is.
Generally, the participants tend not to be at risk, but you have to be 100% sure. These ethical implications make things very complicated. Institutions will have to look for a way to continue patient follow-up of participants. This may mean reducing the number of laboratory tests to the minimum to ensure safety and shortening that follow-up. Of course, this depends on the individual case of the trial but in all cases, actions will need to be put in place in terms of a continuity plan to minimise the harm to patients.
Sponsors also have to stop recruitment if the sponsor cannot fill that funding gap. That can impact the trial even more because if a sponsor had quantified this trial for a specific sample size and that has been reduced, the data readout may be inaccurate. Even if the intervention being assessed is efficacious, the sponsor will not be able to determine that in the trial. That could lead to terminated therapies or adding years to research efforts to allow sponsors to discover whether the intervention is successful.
AB: With the loss of funding from USAID, where do you anticipate funding will come from? Do you think pharmaceutical companies will step in?
AR: The problem is that there is a financial crisis in the industry and that crisis is impacting research. Governments rather than increasing reserves have decreased reserves after Covid-19, the UK is one example, but other countries have done the same. I don’t know if and how these countries will contribute, and whether they have funding there to increase. The financial crisis may make it difficult for pharmaceutical sponsors and other funders to fill the gap. Another potential is the Bill and Melinda Gates Foundation, they may chip in, but this is up to them because they also have their priorities. It’s not going to be easy to suddenly increase funding for something that was not part of the foundation’s agenda. The Bill and Melinda Gates Foundation is already co-funding drug development with USAID, so some research may be able to continue. It’s hard to say at the moment that if USAID is not there, how the industry is going to respond – we will have to see.
AB: It is well known that USAID is used to fund research into HIV, TB and malaria, which are diseases that heavily impact low and low-middle-income countries. How will the funding pull impact infectious disease research in these countries and will the impact in those countries also be felt globally?
AR: The biggest effect will be in low- and middle-income countries because that is where most of the USAID work takes place. The problem here is that when health systems in low- and middle-income countries suffer a sudden shortage of funding, it has a direct impact on mortality among those countries. This however won’t be felt worldwide. Other issues, however, such as antimicrobial resistance for HIV infections and bacterial infections for TB will be more of a concern. Wherever resistance happens, it will expand everywhere. All the patients who were on treatment, such as HIV treatment, that are forced to suddenly stop treatment – those implications will be felt worldwide. This is the same for antimicrobial resistance.
The US also has an impact and a role in response to epidemics and vaccine programmes. It’s harming their own interest in terms of being an internationally important country in the global research space.
AB: Do you anticipate that the lack of funding from USAID may contribute to less drug development in these spaces?
AR: If there is no response, yes, but it depends on how others respond to this. If there is no funded agency or government chipping in, then it will impact upcoming projects that were due to happen in the coming years. There is a short-term impact that we are already feeling and that will continue. That impact is with trials that were supposed to start that will now no longer start. These therapies are already in an advanced process making those earlier efforts a waste of money.
Other research that is at later stages will also be impacted and ongoing trials and drug development may end up being terminated, even if it has shown signs of efficacy. We will see over the years, and I hope other institutions, agencies and other funders will take responsibility, but with the financial crisis, I do not know how we as an industry are going to fill this gap.
