On August 5, 2025, Robert F. Kennedy Jr., the newly appointed U.S. Secretary of Health and Human Services (HHS), posted on the public platform X: “We have reviewed the scientific evidence, consulted with experts, and taken action. The Biomedical Advanced Research and Development Authority (BARDA) has decided to terminate investments in 22 mRNA vaccine development programs, as data indicate these vaccines are ineffective in preventing upper respiratory tract infections such as COVID-19 and influenza. We are redirecting funds toward safer, broader-spectrum vaccine platform technologies that maintain efficacy even amid viral mutations.”
This marks a significant escalation of Kennedy’s anti-vaccine and anti-mRNA technology campaign, delivering another severe blow to an already beleaguered vaccine development landscape.
The announcement may not come as a surprise.
In late May 2025, Moderna, a leading mRNA vaccine developer, received notice from HHS terminating its contract for an avian influenza vaccine candidate. The halted study aimed to evaluate the safety and immunogenicity of the pandemic influenza vaccine candidate mRNA-1018 in approximately 300 healthy adults aged 18 and older. In May, Moderna had disclosed positive interim data from its Phase 1/2 clinical trial and planned to advance the project to later-stage development. HHS’s abrupt termination notice further destabilized Moderna, which is already grappling with multiple challenges.
According to recent reports, a Moderna spokesperson stated that the company has not yet received a formal notice of contract termination from BARDA and is not currently collaborating with the agency. However, Moderna confirmed the study remains ongoing. The spokesperson emphasized that, despite the loss of HHS funding and increased uncertainty, the trial will continue based on robust immune responses and safety data observed in the interim analysis.
Kennedy’s statement represents a major escalation in his anti-vaccine and anti-mRNA campaign. Unlike previous actions targeting specific companies or projects, HHS has now instructed global health investment firms managing BARDA’s venture capital portfolio to “cease all equity investments based on mRNA technology.”
The announcement has stunned experts and stakeholders. Vaccine specialists and public health officials warn that this decision could leave the U.S. lagging months behind other nations in vaccine supply during the next pandemic, creating critical gaps. “This is not prudent regulation—it’s short-sighted self-sabotage. At a time when global health risks are escalating, we are dismantling critical pandemic preparedness capabilities.”
Kennedy countered, stating, “When one door closes, another opens. We have a superior solution for vaccine development.”
This “superior solution” refers to HHS’s Generation Gold Standard initiative, announced in May and spearheaded internally by the National Institutes of Health (NIH). Funded by BARDA, the program centers on a beta-propiolactone (BPL)-inactivated whole-virus platform to develop a universal influenza vaccine with potential cross-protection against coronaviruses and other pathogens. The initiative aims to replace the traditional strain-specific vaccine model, offering broader and longer-lasting immunity, potentially blocking viral transmission and outbreak initiation at the source.
While the plan sparked controversy upon its release, recent developments suggest it will now gain momentum.
Regarding mRNA vaccines, an HHS spokesperson asserted, “The long-term safety and efficacy of these vaccines remain inadequately studied. Until mRNA technology is proven safe and effective, we must prioritize alternative platforms.” The spokesperson cited a recent Senate report accusing the Biden administration of downplaying and delaying public warnings about the risk of myocarditis associated with mRNA-based COVID-19 vaccines. While rare cases of myocarditis have been reported post-vaccination, the risk of myocarditis from SARS-CoV-2 infection itself is higher than that from vaccination.
Kennedy’s stance on mRNA vaccines is well-documented. Earlier reports indicate that the NIH, under his leadership, terminated dozens of vaccine research grants and in March mandated scientists to remove references to mRNA vaccines from funding applications.
This heightened uncertainty casts a shadow over the entire mRNA technology pipeline. The future of this platform—originally conceptualized in the 1960s—has become a pressing concern for the biotech industry.
From a mechanistic perspective, mRNA therapy shares similarities with cell and gene therapies (CGTs), both targeting diseases through genetic information manipulation. In theory, both approaches hold the potential for curative interventions. However, while CGTs directly insert or repair genetic sequences, mRNA delivers transient instructions for protein synthesis without altering the host genome. Consequently, CGTs may offer long-term or lifelong efficacy, whereas mRNA’s effects are temporary due to its degradation over time, minimizing permanent genetic modifications. Additionally, mRNA-based therapies are relatively simpler in technical execution, with theoretically more predictable adverse effects compared to CGTs.
In today’s highly competitive pharmaceutical landscape, mRNA technology still offers unique value. For instance, Moderna is advancing mRNA-based candidates for oncology (e.g., personalized cancer vaccines) and rare disease therapies, even as its preventive vaccine pipeline faces regulatory headwinds. While the preventive vaccine sector may be temporarily constrained, mRNA technology retains therapeutic potential beyond immunization.
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