Recent Updates in Vaccine Regulations Reveal Discrepancies Between Evidence, Policies

On August 5, 2025, Robert F. Kennedy Jr, secretary of the US Department of Health and Human Services (HHS), announced in a video published on X (formerly Twitter) that the Biomedical Advanced Research and Development Authority (BARDA) was terminating 22 mRNA vaccine development contracts.¹ Given the many vaccine-related decisions Kennedy and his staff made since he stepped into this position, the contract cancellations are perhaps not a big surprise; however, the rationale offered may be lacking.

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In this short video, Kennedy states that “mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract” and implies that antigenic drift due to viral mutations is caused by mRNA vaccine use. Does that also mean the immune response to traditional vaccines has caused the antigenic drift observed for many decades with influenza? It is also important to recognize that antigenic drift and more impactful antigenic shifts of respiratory viral pathogens to elude immune response predate the introduction of vaccines into public health. Kennedy continues, “After reviewing the science and consulting top experts at the [National Institutes of Health (NIH)] and [the] FDA, [the] HHS has determined that mRNA technology poses more risk than benefits for these respiratory viruses.”¹ I suppose we will have to await the evidence documents from the experts at the NIH and FDA who support this decision, because, based on the research we have to date, this conclusion is lacking.

Let’s consider evidence related to the performance or benefits of FDA-approved mRNA vaccines for preventing COVID-19, the SARS-CoV-2–related illness. The most recent—and probably most conservative—study of the mortality benefit of COVID-19 vaccination estimates that more than 2.5 million deaths were averted worldwide (1 death per 5400 vaccine doses administered), which represents an estimated 14.8 million life-years saved (1 life-year saved per 900 vaccine doses) from 2020 to 2024. The greatest benefit on mortality was for adults older than 60 years.² While this study included all COVID-19 vaccines administered, in many parts of the world—including the US and the European Union—the mRNA formulations were far and away the most commonly administered.³ Despite Kennedy implying in his video that the mRNA vaccines were ineffective during the Omicron variant wave, this study concluded that the greatest mortality benefit was observed during the Omicron period.⁴ In addition, a CDC-sponsored study⁵ reported by the VISION and IVY networks concluded that updated 2023 and 2024 mRNA-based COVID-19 vaccines (monovalent XBB.1.5) provided more than 50% increased protection against COVID-19–associated emergency department and urgent care visits as well as hospitalizations in immunocompromised US adults compared with no updated vaccine. Of note is that this study was conducted when multiple Omicron variants were circulating.⁵ Multiple studies have also demonstrated that for patients hospitalized with COVID-19 infection, prior vaccination was associated with lesser severity of illness, decreased length of stay, reduced intensive care unit admissions, and lower mortality.^5,6

The CDC (a division of HHS) website states unequivocally that COVID-19 vaccination saves lives and prevents severe disease.⁷ In addition, the CDC website that provides updates on COVID-19 vaccine effectiveness provides annotated summaries and links to multiple CDC-sponsored studies of the effectiveness of the mRNA vaccines in adults and children.⁸ The full body of evidence supporting the benefits of COVID-19 vaccination, especially in older adults, is too extensive to be cited in this brief commentary.

Given the well-documented benefits of mRNA vaccines for SARS-CoV-2, the risks may be significant if experts conclude that “mRNA technology poses more risks than benefits.” The reality is that the mRNA vaccines for SARS-CoV-2 have been administered to billions of patients since 2020, permitting the development of one of the most well-defined safety profiles for any vaccine, and potentially for any FDA-approved drug.

As with any vaccine, there have been rare but serious adverse events that should not be downplayed; however, for many, including cardiac inflammatory reactions in young males and thrombotic complications, the risk of these complications with active COVID-19 infection is significantly greater. For example, in 1 study, the risk of cardiac complications in males aged 12 to 17 years was 1.8 to 5.6 times higher after getting COVID-19 disease than after receiving 2 doses of an mRNA COVID-19 vaccine, and for males 30 years and older, risk ratios were 10.8 to 115.2 with active infection compared with 2 doses of vaccine.⁹ The evidence to date demonstrates the mRNA vaccines for COVID-19 are safe in high-risk groups, including pregnant women and their unborn children,^10,11 and children aged 6 months to 18 years.^12-16 The CDC dedicates a webpage to the safety of COVID-19 mRNA vaccines during pregnancy and breastfeeding, a group that has been at high risk of complications from COVID-19.¹⁷ The overall evidence of the safety of mRNA vaccines is too extensive to be fully cited in this commentary.

I am not a virologist or a recognized expert on vaccine science; however, I am a health care professional who can review and understand the evidence, and to date, none of it adds up to the justification Kennedy provided for BARDA’s cancellation of more than $500 million worth of contracts. mRNA technologies provided a rapid pathway to vaccine development for new and emerging pathogens, arguably contributing to the biggest accomplishment of the first Trump administration—that is, mRNA vaccines targeting SARS-CoV-2—and hold promise for the treatment of other diseases (eg, interfering-RNA technologies). How much future benefit might be lost due to this reversal of support, and how much existing investment may go unused? The well-documented inconsistencies of Kennedy’s recommendations seem to override the evidence, which may lead to further degradation of public health policy on vaccines.

The overall vaccine-related policy changes may adversely affect vaccine availability, approved indications, CDC guidance, insurance coverage, and the role that health systems pharmacists can continue to play in public health. I am curious to see how much can be done during a 4-year term, how long it will take to repair any damage, and what potential effects on public health and safety will linger. Time will tell.

REFERENCES

1. @SecKennedy. We reviewed the science, listened to the experts, and acted. 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. August 5, 2025. Accessed August 12, 2025. https://x.com/SecKennedy/status/1952851097019633766

2. Ioannidis JPA, Pezzullo AM, Cristiano A, Boccia S. Global estimates of lives and life-years saved by COVID-19 vaccination during 2020-2024. JAMA Health Forum. 2025;6:e252223. doi:10.1001/jamahealthforum.2025.2223

3. COVID-19 vaccine doses administered by manufacturer. Our World in Data. Accessed August 12, 2025. https://ourworldindata.org/grapher/covid-vaccine-doses-by-manufacturer?country=USA~OWID_EU27

4. de Moraes EV, Pires MC, Costa AAA, et al. Comprehensive statistical analysis reveals significant benefits of COVID-19 vaccination in hospitalized patients: propensity score, covariate adjustment, and feature importance of permutation. BMC Infect Dis. 2024:24(2):1052. doi:10.1186/s12879-024-09865-1

5. DeCuir J, Payne AB, Self WH, et al. Interim effectiveness of updated 2023–2024 (monovalent XBB.1.5) COVID-19 vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalization among immunocompetent adults aged ≥18 years - VISION and IVY Networks, September 2023-January 2024. MMWR Morb Mortal Wkly Rep. 2024;73(8):180-188. doi:10.15585/mmwr.mm7308a5

6. Maleki B, Sadeghian AM, Ranjbar M. Impact of vaccination against SARS-CoV-2 on mortality risk, ICU admission rate, and hospitalization length in hospitalized COVID-19 patients: a cross-sectional study. BMC Infect Dis. 2025;25(1):144. doi:10.1186/s12879-025-10530-4

7. 5 things you should know about COVID-19 vaccines. CDC. October 13, 2023. Accessed August 12, 2025. https://www.cdc.gov/ncird/whats-new/5-things-you-should-know.html 8. COVID data tracker. CDC. Accessed August 12, 2025. https://covid.cdc.gov/covid-data-tracker/#vaccine-effectiveness

8. COVID data tracker. CDC. Accessed August 12, 2025. https://covid.cdc.gov/covid-data-tracker/#vaccine-effectiveness

9. Block JP, Boehmer TK, Forrest CB, et al. Cardiac complications after SARS-CoV-2 infection and mRNA COVID-19 vaccination — PCORnet, United States, January 2021-January 2022. MMWR Morb Mortal Wkly Rep. 2022;71(14):517-523. doi:10.15585/mmwr.mm7114e1

10. Gerede A, Daskalakis G, Mikos T, et al. Safety of COVID-19 vaccination in pregnancy: a systematic review. Diagnostics (Basel). 2024;14(16):1775. doi:10.3390/diagnostics14161775

11. Fleming-Dutra KE, Zauche LH, Roper LE, et al. Safety and effectiveness of maternal COVID-19 vaccines among pregnant people and infants. Obst Gynecol Clin North Am. 2023;50(2):279-297. doi:10.1016/j.ogc.2023.02.003

12. Copland E, Patone M, Saatci D, et al. Safety outcomes following COVID-19 vaccination and infection in 5.1 million children in England. Nat Commun. 2024;15(1):3822. doi:10.1038/s41467-024-47745-z

13. Nafilyan V, Bermingham CR, Ward IL, et al. Risk of death following COVID-19 vaccination or positive SARS-CoV-2 test in young people in England. Nat Commun. 2023;14(1):1541. doi:10.1038/s41467-023-36494-0

14. Zinzi A, Gaio M, Liguori V, et al. Safety monitoring of mRNA COVID-19 vaccines in children aged 5 to 11 years by using EudraVigilance pharmacovigilance database: The CoVaxChild study. Vaccines (Basel). 2023;11(2):401. doi:10.3390/vaccines11020401

15. Anderson EJ, Creech CB, Berthaud V, et al. Evaluation of mRNA-1273 vaccine in children 6 months to 5 years of age. N Engl J Med. 2022;387(18):1673-1687. doi:10.1056/NEJMoa2209367

16. Goddard K, Donahue JG, Lew N, et al. Safety of COVID-19 mRNA vaccination among young children in the Vaccine Safety Datalink. Pediatrics. 2023;152(1):e2023061894. doi:10.1542/peds.2023-061894

17. COVID-19 vaccination for women who are pregnant or breastfeeding. CDC. September 10, 2024. Accessed August 12, 2025. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html