Summary
HHS has canceled 22 BARDA-funded mRNA vaccine contracts, totaling $500 million, as part of a broader shift away from mRNA platforms and toward vaccine technologies deemed more resilient to viral mutation. The decision reflects heightened regulatory scrutiny, with new trial requirements emphasizing clinical outcomes over surrogate endpoints. As federal support pivots, clinical operations teams should prepare for tighter oversight, shifting sponsor priorities, and reduced funding availability for nucleic acid-based vaccine trials.
The US Department of Health and Human Services (HHS) has announced what it is calling a “coordinated wind-down” of mRNA vaccine activities under the Biomedical Advanced Research and Development Authority (BARDA). This action includes the cancellation of 22 contracts focused on mRNA vaccine research, impacting $500 million worth of funding originally awarded by BARDA.1
Funding shift targets broader, mutation-resistant platforms
In a press release issued by the HHS, Secretary Robert F. Kennedy, Jr. said: “BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”
Key contract terminations and restructuring
The wind-down will begin to take effect with the following actions:
- Contracts with Emory University and Tiba Biotech are being terminated.
- mRNA-related activities are being scaled back in existing agreements with Luminary Labs, ModeX, and Seqirus.
- Multiple pre-award proposals have been rejected or canceled under BARDA’s Rapid Response Partnership Vehicle (RRPV) and VITAL Hub, including submissions from Pfizer, Sanofi Pasteur, CSL Seqirus, and Gritstone.
- Collaborative efforts with the Department of Defense Joint Program Executive Office (DoD-JPEO) are being restructured, impacting nucleic acid vaccine projects with AAHI, AstraZeneca, HDT Bio, and Moderna/UTMB.
While no new mRNA research will begin under this wind-down, the agency is allowing some final-stage contracts to run their course.
Kennedy added: “Let me be absolutely clear: HHS supports safe, effective vaccines for every American who wants them. That’s why we’re moving beyond the limitations of mRNA and investing in better solutions.”
Regulatory scrutiny increases amid vaccine funding cuts
This move by the HHS comes during an already turbulent time in vaccine research and development. In May, FDA Commissioner Martin A. Makary, MD, MPH, along with Vinay Prasad MD, MPH, then head of the FDA’s Center for Biologics Evaluation and Research (CBER), who has since stepped down from the role, outlined a new framework for COVID-19 vaccine clinical trials. The updated framework calls for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications (BLAs) can be granted.2
Moderna’s bird flu vaccine among impacted programs
In June, the HHS terminated a $590 million grant previously awarded to Moderna to accelerate the development of pre-pandemic influenza vaccines, despite a positive readout from the biotech’s Phase I/II trial (NCT05972174) of mRNA-1018 targeting the H5 bird flu.3
In a statement from the time of the Moderna grant termination, HHS Communications Director Andrew Nixon said: “After a rigorous review, we concluded that continued investment in Moderna’s H5N1 mRNA vaccine was not scientifically or ethically justifiable. The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.”
Federal priorities and oversight undergoing major transition
Led by Kennedy, the HHS is clearly signaling major changes in federal vaccine development priorities, including the tightening of clinical trial design. On top of increased oversight, the industry has been dealing with funding cuts dating back to when the current administration took office.
In March, Applied Clinical Trials spoke with Ron Lanton, partner, Lanton Law on the potential impact of medical research funding cuts. In a video interview, Lanton explained: “This entire situation is disheartening. It could halt many clinical trials focusing on minority groups and stifle progress on certain vaccines. This could lead to entire sectors of science receiving neither funding nor attention. I don’t think we fully understand the magnitude of this yet—it won’t be clear until it actually happens.”
References
1. HHS Winds Down mRNA Vaccine Development Under BARDA. News release HHS. August 5, 2025. Accessed August 6, 2025. https://www.hhs.gov/press-room/hhs-winds-down-mrna-development-under-barda.html
2. FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research. Applied Clinical Trials. May 21, 2025. Accessed August 6, 2025. https://www.appliedclinicaltrialsonline.com/view/fda-outlines-updated-requirement-placebo-controlled-trials-vaccine-research
3. HHS Cancels Moderna Grant for Late-Stage Development of mRNA Vaccine Candidate. Applied Clinical Trials. June 4, 2025. Accessed August 6, 2025. https://www.appliedclinicaltrialsonline.com/view/hhs-cancels-moderna-grant-late-stage-development-mrna-vaccine-candidate
