RFK Jr., HHS Pull the Plug on Federal Funding for mRNA Vaccine Research and Development
On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and Development Authority (BARDA).
Simultaneously, HHS Secretary Robert F. Kennedy, Jr., reiterated the announcement on social media and at a news conference in Anchorage, Alaska. HHS stated that this decision follows its comprehensive review of mRNA investments made during the COVID-19 public health emergency and affects 22 projects valued at nearly $500 million.
Key Contracts and Partnerships Impacted
The wind-down includes the termination of contracts with several research institutions and biotech firms, such as Emory University and Tiba Biotech, and the de-scoping of mRNA-related work in existing agreements with companies like Luminary Labs, ModeX, and Seqirus. Additionally, multiple pre-award solicitations from major pharmaceutical companies — including Pfizer, Sanofi Pasteur, CSL Seqirus, and Gritstone — have been rejected or cancelled. Collaborations with the US Department of Defense’s Joint Program Executive Office are also being restructured, impacting mRNA-based vaccine projects with partners such as Access to Advanced Health Institute, AstraZeneca, HDT Bio, and Moderna/UTMB.
While some late-stage contracts (notably with Arcturus and Amplitude) will be allowed to conclude to preserve prior taxpayer investment, HHS has made it clear that no new mRNA-based projects will be initiated. The Global Health Investment Corporation, which manages BARDA Ventures, has also been directed to halt all mRNA-based equity investments.
Strategic Shift Toward “Safer, Broader” Vaccine Platforms
The HHS announcement includes the following quote from Secretary Kennedy, “We reviewed the science, listened to the experts, and acted…because the data show these [mRNA] 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,” identified by HHS as “evidence-based, ethically grounded solutions — like whole-virus vaccines and novel platforms.” The Secretary is also quoted by the Associated Press as saying that the Administration’s focus is a “universal vaccine” that mimics “natural immunity.” The announcements raise a number of questions, including the following.
- Whether the 22 defunded projects are limited to those targeting viruses affecting the upper respiratory tract or include other areas of mRNA vaccine research. While the HHS announcement states that other uses of mRNA technology within the Department are not impacted by the announcement, it also states that “no new mRNA-based projects will be initiated.”
- The scientific and expert support for the decision, which appears to have faced criticism by vaccine experts in both the United States and the United Kingdom.
- Timing and next steps related to the proposed “universal vaccine” referred to by Secretary Kennedy in his Anchorage speech.
Also still to be determined are the impacts that the new approach will have on rapid response readiness. For example, whole-vaccine virus technology, which involves a lengthy ramp-up process, poses challenges when the vaccine target is fast-mutating or involves an ever-changing mix of viral strains. Developing the annual influenza vaccine, for example, involves a months-long process of selecting the strains to be targeted in a particular year, growing the vaccine at scale in chicken eggs, and finally preparing and distributing the doses.
In contrast, new mRNA vaccines can be developed, scaled up, and distributed on a much shorter timeline, enabling a rapid response when compared to other approaches. Indeed, the developers of mRNA vaccine technology (Katalin Karikó and Drew Weissman) were awarded the Nobel Prize for Physiology or Medicine in 2023.
Although HHS’ declared intention is to shift funding to what it considers to be safer vaccine platforms, Centers for Disease Control and Prevention data, among others, have shown the mRNA COVID vaccines to have a high safety profile, with adverse side effects following vaccination “rarely…observed” in the United States.
Implications for the Vaccine Development Landscape
This policy shift marks a new direction for federal vaccine research and development, with a “focus on platforms with stronger safety records and transparent clinical and manufacturing data practices.”
Businesses and research organizations involved in vaccine development should closely monitor these changes, as future federal funding and partnership opportunities will increasingly favor HHS’ prioritized technologies.
Our team will continue to monitor developments and provide updates as they become available. Please reach out to your ArentFox Schiff attorney contact or one of the authors with questions.
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