Iranian Journal of Medical Sciences

Document Type : Editorial

Author

1 Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

2 Department of Pharmaceutical Biotechnology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran

3 Department of Artificial Intelligence, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

Abstract

The last month’s decision by the U.S. Department of Health and Human Services (HHS) to withdraw nearly $500 million from mRNA vaccine research and development (R&D) has aroused concern in the scientific and medical communities.

Highlights

Manica Negahdaripour (Google Scholar)

Keywords

The last month’s decision by the U.S. Department of Health and Human Services (HHS) to withdraw nearly $500 million from mRNA vaccine research and development (R&D) has aroused concern in the scientific and medical communities. HHS Secretary Kennedy stated that mRNA vaccine platforms “fail to protect effectively against upper respiratory infections” and “pose more risks than benefits for these respiratory viruses”. He said that “safer” alternatives—such as whole inactivated virus vaccines (WIVVs)—will receive renewed attention, claiming they may offer better long-term protection and fewer potential problems.1 Public concerns about mRNA vaccines were also acknowledged.

Twenty-two mRNA vaccine development projects led by BARDA (the Biomedical Advanced Research and Development Authority) were stopped. 1 This action devalues a technology that has shown its worth during the pandemic and in overall biomedical progress. It comes at a moment when efforts on mRNA research are starting to show noticeable advances across several fields.

Reviewing the mechanism of mRNA vaccines shows why this platform should continue to receive support. These vaccines send genetic instructions that cause cells to produce safe fragments of a viral protein (e.g., the SARS-CoV-2 spike), eliciting immune responses, without introducing live pathogens. 2 They allow quick and flexible creation of vaccines for new variants and have a reasonable safety record, caused by mRNA’s short half-life. 3 Data on mRNA COVID-19 vaccines confirm they are safe and effective. Large clinical trials of mRNA-1273 and BNT162b2 demonstrated high efficacy (94-95%) against symptomatic infection. 4 , 5 A 2024 meta-analysis of 50 studies confirmed the real-world success rate of 84–86% for both 2-dose and 3-dose regimens. 6 A 2025 cohort study on the JN.1-updated mRNA vaccine showed over 90% protection against hospitalization and death in seniors lasting for at least 4 months, with no increased risk across 29 monitored adverse events. 7 Though there were rare cases of myocarditis (about 1 in 50,000 young males), they were more serious after natural infection. When comparing 22 COVID-19 vaccine types, BNT162b2 was the most effective in preventing symptomatic infection in adults and the elderly. 8 mRNA vaccines had slightly higher rates of mild side effects than WIVVs, but their serious adverse events were no worse than those of the placebo. 9

The flexibility and speed of mRNA vaccine development not only helped in tackling the COVID-19 crisis 10 but also created opportunities for new treatments. Importantly, mRNA vaccine technology shows potential for cancer care and rare genetic diseases. Activating immunity against tumor-specific antigens in several cancers (mostly melanoma and non-small cell lung cancer) has brought a personalized approach to early oncology trials. Although the stopped projects focused on COVID-19, influenza, and other respiratory viruses, and do not currently involve mRNA cancer vaccines, the potential negative impact could hinder future progress in oncology. This could weaken resources, raise costs, and limit patient access to related trials. This change may slow advances that are close to happening and discourage researchers in this field. It also sends a negative signal to investors and global partners. While cutting funding may reduce private investment in the US, especially in early-stage projects, some other countries, such as China, Germany, and Japan, continue to invest heavily in mRNA infrastructure, which may shift innovation away from the US.

The wider impact goes beyond science and influences policy and public opinion. The success of mRNA vaccines faced intense review, misinformation, and politics. Reducing support now might enhance skepticism and doubts about safety and worth. This could damage public trust in all vaccines and worsen vaccine hesitancy, which already causes outbreaks of preventable diseases such as measles. Thus, clear communication is key for explaining funding decisions and reinforcing the scientific agreement on the benefits of mRNAs. It can help ensure that policy shifts are understood as strategic adjustments rather than retreat.

Instead of stepping back, a careful, balanced approach is needed. Given the known limitations of WIVVs in scaling production, longer setup times during emergencies, and their risk of mismatching with circulating strains, research on diverse platforms—including mRNA, DNA, viral vectors, and protein subunits—is recommended. Future funding decisions should rely on clear, peer-reviewed evidence. This includes standard endpoints, consistent safety monitoring, head-to-head studies comparing mRNA with other platforms, and strong real-world effectiveness data across different age groups and health conditions.

Overall, the shutdown will hurt multiple projects aimed at improving fast-response vaccine technologies, both in the US and globally. Still, the mRNA platform is not a finished chapter; it is a foundation. Its flexibility, speed, and scaling potential make it very suitable for managing current and unexpected medical needs. The lessons learned from the pandemic, the infrastructure developed, and the trust gained through successful usage should not be ignored. While scientific evidence supports ongoing research on mRNA technology for various indications, a balanced, evidence-based approach can protect public health while promoting biomedical progress. The future of medicine relies not only on novel ideas but also on the willingness to continue the initiatives that have already started to improve lives.

Conflict of Interest

None declared.

References

  1. Health Services DH [Internet]. HHS Winds Down mRNA Vaccine Development Under BARDA. [cited 2 Sept. 2025]. Available at: https://www.hhs.gov/press-room/hhs-winds-down-mrna-development-under-barda.html
  2. Mohammadi Y, Nezafat N, Negahdaripour M, Eskandari S, Zamani M. In silico design and evaluation of a novel mRNA vaccine against BK virus: a reverse vaccinology approach. Immunol Res. 2023; 71:422-41. Publisher Full Text | DOI | PubMed [ PMC Free Article ]
  3. Negahdaripour M, Ghasemi Y. Witnessing a revolution in the vaccinology field: A thought on its probable impact on future vaccines. Trends in Pharmaceutical Sciences and Technologies. 2022; 8:67-8.
  4. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020; 383:2603-15. Publisher Full Text | DOI | PubMed [ PMC Free Article ]
  5. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021; 384:403-16. Publisher Full Text | DOI | PubMed [ PMC Free Article ]
  6. Wong BK, Mabbott NA. Systematic review and meta-analysis of COVID-19 mRNA vaccine effectiveness against hospitalizations in adults. Immunother Adv. 2024; 4:11. Publisher Full Text | DOI | PubMed [ PMC Free Article ]
  7. Hansen CH, Lassauniere R, Rasmussen M, Moustsen-Helms IR, Valentiner-Branth P. Effectiveness of the BNT162b2 and mRNA-1273 JN.1-adapted vaccines against COVID-19-associated hospitalisation and death: a Danish, nationwide, register-based, cohort study. Lancet Infect Dis. 2025. DOI | PubMed
  8. Stowe J, Miller E, Andrews N, Whitaker HJ. Risk of myocarditis and pericarditis after a COVID-19 mRNA vaccine booster and after COVID-19 in those with and without prior SARS-CoV-2 infection: A self-controlled case series analysis in England. PLoS Med. 2023; 20:e1004245. Publisher Full Text | DOI | PubMed [ PMC Free Article ]
  9. Wu X, Xu K, Zhan P, Liu H, Zhang F, Song Y, et al. Comparative efficacy and safety of COVID-19 vaccines in phase III trials: a network meta-analysis. BMC Infect Dis. 2024; 24:234. Publisher Full Text | DOI | PubMed [ PMC Free Article ]
  10. Negahdaripour M. COVID-19 Vaccine Global Access Is an Urgency. Iran J Med Sci. 2021; 46:79-80. Publisher Full Text | DOI | PubMed [ PMC Free Article ]