HHS Terminates $500 Million in mRNA Vaccine Development, Claiming Ineffectiveness

The United States Department of Health and Human Services (HHS), led by Secretary Robert F. Kennedy Jr, has announced the termination of 22 mRNA vaccine development investments totaling nearly $500 million under the Biomedical Advanced Research and Development Authority (BARDA). The news was announced by Kennedy through a video posted on X and confirmed with a news release from HHS.^1,2

New leadership at HHS have been scrutinizing vaccines. | Image Credit: © Rafael Henrique - stock.adobe.com

“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,” Secretary Kennedy said in the news release. “We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”¹

Details of the Cancellations

The wind-down of mRNA vaccine investment will include the descoping and cancellation of a series of programs and solicitations, according to the news release. These include the termination of contracts with Tiba Biotech and Emory University; the descoping of mRNA-related activities in some existing contracts; the rejection or cancellation of multiple preaward solicitations; and the restructuring of certain collaborations involving research into mRNA vaccine technology.¹

Though some contracts in their final stage will be allowed to run their course, the department has no plans to initiate new mRNA-based projects. Simultaneously, HHS has instructed their partner, the Global Health Investment Corporation, to cease mRNA-based equity investments through BARDA.¹

The move follows a similar announcement from Secretary Kennedy in May 2025 that HHS would be cancelling a series of grants awarded to Moderna through BARDA for the development of prepandemic influenza vaccines, including against H5N1 avian influenza, known as bird flu. Pharmacy Times reached out to HHS for comment on the grant cancellations, if there were more actions on mRNA technology to follow, and the scientific basis for their decision.^1,3

mRNA Vaccine Technology is Proven Safe and Effective

In the news release and his video on X, Secretary Kennedy makes a series of claims against mRNA vaccine technology, many of which have been proven false by myriad investigations and research initiatives.

“As the pandemic showed us, mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract,” Kennedy alleged in his post on X. He claimed that, because mRNA only codes for a single antigen in a virus, 1 mutation to a virus could make the vaccine ineffective, as seemingly proven during the Omicron variant wave during the COVID-19 pandemic. He claimed, “The vaccine paradoxically encourages new mutations and can actually prolong pandemics as the virus mutates to escape the protective effects of the vaccine."¹

When the mRNA COVID-19 vaccines were first proliferated, it was noted that they do not provide full protection against acquiring an infection; however, they do provide robust and sustained risk reductions for critical illness, hospitalization, and long COVID, according to the CDC. Although mRNA vaccines do indeed wane in protection over time, the widespread infections in vaccinated persons reported during the Omicron wave cannot be solely attributed to supposed weaknesses in mRNA technology. Rather, individual factors, the large presence of immunity towards 1 variant in the population, and changing characteristics of the virus can explain breakthrough infections.^4,5

Research into the safety of mRNA vaccines administered at the beginning of the pandemic has solidified that any possible adverse events were mostly mild and short in duration. One study analyzed safety data from over 298 million doses of mRNA COVID-19 vaccine and affirmed such conclusions. Furthermore, a review of mRNA vaccines indicates the numerous advantages they have over traditional vaccines, including high potency and ease of modification, allowing these vaccines to be easily changed in response to emerging variants. This is what took place in the years since the Omicron variant, with vaccine manufacturers altering the makeup of their mRNA vaccines to better protect against circulating variants.^6,7

The allegations against mRNA technology may be misdirected, with the technology possibly allowing for even speedier adaptation to emerging variants compared with traditional vaccines. Traditional, whole-cell vaccines require preparation in a laboratory and pose concerns for DNA integration and infectiousness, as they implant a version of the disease in a patient to induce immunity. Contrastingly, mRNA vaccines are non-infectious and made through a cell-independent process. As mentioned, the manufacturing process for mRNA vaccines is sequence-independent, allowing for low-cost adaptation to novel pathogens.^1,8

Indeed, during the Omicron variant, protection towards COVID-19 waned as the variant evaded immunity and caused breakthrough infections and hospitalizations. However, numerous authors have affirmed that mRNA vaccine boosters can successfully reestablish effectiveness. Additionally, the primary vaccination series was found to preserve strong protection against severe disease and hospitalization, which was bolstered with a booster.⁹

Patient Counseling

Altogether, mRNA vaccines represent a major clinical advancement that—contrary to the Secretary’s claims—provide broad effectiveness and safety towards COVID-19 and other illnesses. Alterations and cancellations to mRNA vaccine investment projects do not mean that mRNA vaccine technology is not effective; in fact, the opposite is true. However, these actions from HHS—and possible future policies—could lead to increased vaccine hesitancy from patients.⁶

Pharmacists have a critical role to play in providing patients evidence-based recommendations and counseling regarding mRNA COVID-19 vaccination, including in advocating for their safety and effectiveness. If a patient presents with concerns regarding mRNA vaccines—whether because of or partially due to BARDA’s grant cancellations—pharmacists are essential in reviewing the extensive safety data regarding mRNA vaccines and certifying their effectiveness at preventing severe illness and death.

Additionally, if future actions are taken towards mRNA technology or new guidance is issued from HHS, pharmacists are important in communicating such changes to patients and their families.

REFERENCES

1. @SecKennedy on X. Published on August 5, 2025 at 5:55 PM. Accessed August 6, 2025. https://x.com/SecKennedy/status/1952851097019633766

2. Department of Health and Human Services. HHS winds down mRNA vaccine development under BARDA. News Release. Released August 5, 2025. Accessed August 5, 2025. https://www.hhs.gov/press-room/hhs-winds-down-mrna-development-under-barda.html#:~:text=%E2%80%9CBARDA%20is%20terminating%2022%20mRNA,effective%20even%20as%20viruses%20mutate.%E2%80%9D

3. Halpern L. HHS cancels millions in pandemic influenza mRNA vaccine development grants. Pharmacy Times. Published May 30, 2025. Accessed August 6, 2025. https://www.pharmacytimes.com/view/hhs-cancels-millions-in-pandemic-influenza-mrna-vaccine-development-grants

4. CDC—COVID-19. Benefits of getting vaccinated. Last Updated June 11, 2025. Accessed August 6, 2025. https://www.cdc.gov/covid/vaccines/benefits.html#:~:text=weakened%20immune%20system-,The%202023%E2%80%932024%20COVID%2D19%20vaccines%20reduced%20the%20risk%20of,11

5. Cox C, Amin K, Kates J, Michaud J. Why do vaccinated people represent most COVID-19 deaths right now? KFF. Published November 30, 2022. Accessed August 6, 2025. https://www.kff.org/policy-watch/why-do-vaccinated-people-represent-most-covid-19-deaths-right-now/#:~:text=There%20are%20many%20more%20vaccinated%20people%20than,for%20some%20of%20these%20factors%20(age%20and

6. Rosenblum HG, Gee J, Liu R, et al. Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Lancet Infect Dis. 2022;22(6):802-812. doi:10.1016/S1473-3099(22)00054-8

7. Jamous YF, Alhomoud DA. The Safety and Effectiveness of mRNA Vaccines Against SARS-CoV-2. Cureus. 2023;15(9):e45602. doi:10.7759/cureus.45602

8. Vanderbilt Institute for Infection, Immunology and Inflammation. How does a mRNA vaccine compare to a traditional vaccine? Vanderbilt University Medical Center. Published November 16, 2020. Accessed August 6, 2025. https://www.vumc.org/viiii/infographics/how-does-mrna-vaccine-compare-traditional-vaccine

9. Paul P, El-Naas A, Hamad O, et al. Effectiveness of the pre-Omicron COVID-19 vaccines against Omicron in reducing infection, hospitalization, severity, and mortality compared to Delta and other variants: A systematic review. Hum Vaccin Immunother. 2023;19(1):2167410. doi:10.1080/21645515.2023.2167410