Federal government halts mRNA vaccine development efforts
The United States Department of Health and Human Services (HHS) has made a controversial decision to terminate 22 mRNA vaccine research projects, totaling nearly $500 million, citing data-driven ineffectiveness of these vaccines for upper respiratory infections like COVID-19 and influenza [1][2][4].
This move impacts ongoing efforts for COVID-19 and flu vaccines, with some final-stage contracts allowed to complete but no new mRNA vaccine projects to be initiated under the Biomedical Advanced Research and Development Authority (BARDA)’s funding [1][2][3].
The decision has sparked significant concerns within the scientific community. While HHS Secretary Robert F. Kennedy Jr. maintains that funding will shift to safer and broader vaccine platforms, many scientists argue that mRNA vaccines have been highly effective at preventing severe disease, hospitalizations, and deaths during the COVID-19 pandemic [2][5]. There is a worry that ending federal support may reduce US preparedness for future pandemics and hinder innovation in mRNA-based therapeutics.
Katalin Kariko, who shared the Nobel prize in physiology or medicine in 2023 for her work on mRNA vaccines, called Kennedy's decision a "huge mistake" based on misinformation [6]. Jeff Coller, an expert on RNA biology from Johns Hopkins University, called the HSS action a "shot across the bow to the entire mRNA industry" [7].
The Biotechnology Innovation Organization (BIO) criticized the HHS decision, stating that retraction of investment in one area of research for mRNA could erode progress and discourage investment in other promising areas, such as cancer and rare diseases [8]. Justin Richner, a microbiologist and immunologist from the University of Illinois, expressed concerns that the HHS decision could influence the entire sector, leading companies to develop mRNA therapeutics overseas [2].
Increased regulatory scrutiny and new clinical trial requirements under HHS, emphasizing clinical outcomes rather than surrogate endpoints for vaccine approval, may also contribute to the strategic pivot to other vaccine technologies [3]. However, many experts warn that this decision could undermine a highly promising and versatile technology platform, potentially setting back US scientific leadership compared to other countries continuing mRNA research, such as China [2][5].
In response to the terminated projects, HHS announced a focus on safer, broader vaccine strategies like whole-virus vaccines and novel platforms that don't collapse when viruses mutate [9]. Despite the challenges, scientists like Richner are considering applying for funding from non-governmental organizations and governmental agencies outside of the US.
References:
- HHS Terminates mRNA Vaccine Research Projects
- Scientists Worry About Future of mRNA Vaccine Research in the US
- HHS Announces New Clinical Trial Requirements for Vaccines
- HHS Secretary Doubts mRNA Vaccines Before Taking Office
- Ending Federal Support for mRNA Vaccines Could Harm US Leadership
- Kariko Calls HHS Decision a "Huge Mistake"
- Coller: HSS Action a "Shot Across the Bow"
- BIO Criticizes HHS Decision to Terminate mRNA Vaccine Research Projects
- HHS to Prioritize Safer, Broader Vaccine Strategies
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