Originally published by our sister publication Infectious Disease Special Edition

By Gina Shaw

The Department of Health and Human Services' cancellation of $500 million in mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA), announced by Secretary Robert F. Kennedy Jr., will have catastrophic effects on future pandemic preparedness and could undo U.S. innovation in a technology that holds promise, not only for infectious diseases, but cancer immunotherapy and other diseases, leading scientists said.

“mRNA is a promising technology for a number of applications, not just for COVID, where that vaccine saved millions of lives, but for other infectious diseases as well as other platforms like cancer immunotherapy and gene therapy,” said Paul Offit, MD, the director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

Former BARDA head Rick Bright, PhD, called the move, “A bad day for science, and huge blow to our national security,” in comments on X (formerly Twitter), adding: “This decision will have dangerous repercussions.” In another post, Dr. Bright warned, "BARDA invested in mRNA technology precisely because it could deliver safe, scalable vaccines in record time, a capability proven during COVID. By dismantling that platform, we’re crippling our front-line defense, just ahead of unknown biological threats.”

The Infectious Disease Society of America also strongly criticized the cuts, calling the funding cuts deeply concerning. “[They] reflect an alarming pattern of the administration’s efforts to curtail vaccine research and sow unfounded doubt in vaccine safety and effectiveness,” said IDSA President Tina Tan, MD, FIDSA, FPIDS, FAAP, in a statement. “IDSA fully agrees with HHS that the U.S. should invest in additional vaccine technologies, but those efforts should not replace ongoing, promising research. Significant data demonstrate that mRNA vaccines are safe and highly effective at preventing severe disease, hospitalization and death due to COVID-19. mRNA technology also shows potential against other respiratory pathogens like influenza and is worthy of further study.”

According to the HHS statement, the wind-down includes:

  • termination of contracts with Emory University and Tiba Biotech;
  • de-scoping of mRNA-related work in existing contracts with CSL Seqirus, Luminary Labs and ModeX;
  • rejection or cancellation of multiple pre-award solicitations, including proposals from CSL Seqirus, Gritstone, Pfizer, Sanofi Pasteur and others, as part of BARDA’s Rapid Response Partnership Vehicle and VITAL Hub; and
  • restructuring of collaborations with DOD-JPEO (the Department of Defense and Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense), affecting nucleic acid–based vaccine projects with AAHI, AstraZeneca, HDT Bio and Moderna/UTMB.

“We reviewed the science, listened to the experts, and acted,” Mr. Kennedy said in the HHS statement without naming the experts. “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.”

But that statement reflects a fundamental misunderstanding and mischaracterization of the science, according to Dr. Offit. “He has said that we have a better platform with the whole killed viral vaccine. But China used the whole killed viral vaccine for SARS [severe acute respiratory syndrome], and it did not perform as well [as mRNA vaccines]. It didn’t induce as high an antibody response, and the longevity wasn’t as good. The mRNA vaccines were much better.”

Alternatives like whole-virus or protein-based vaccines typically take longer to develop and scale, potentially delaying mass immunization in rapidly evolving health crises, he explained.

In an Aug. 6 presentation on X, Mr. Kennedy questioned the safety and efficacy of the COVID-19 vaccine program. “As the pandemic showed, mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract … because mRNA only codes for a small part of the viral proteins, which I think is what happens with all vaccines. Usually a single antigen, one mutation and the virus becomes ineffective,” he said. “This dynamic drives a phenomenon called antigenic shift, meaning that the vaccine paradoxically encourages new mutations and can actually prolong pandemics.”

Peter Marks, MD, who was the director of the FDA’s Center for Biologics Evaluation and Research for nine years, said Mr. Kennedy’s statements reflect a fundamental misunderstanding of both virology and mRNA technology. “Moreover, they [Mr. Kennedy’s statements] do not reflect what actually happened during the COVID pandemic,” he told Infectious Disease Special Edition. 

A recent study in JAMA Health Forum showed that COVID-19 vaccination actually saved an estimated 2.5 million lives (2025;6[7]:e252223).

“Vaccines do not have to be 100% effective to be beneficial for public health. Additionally, they do not have to entirely prevent infection in order to be beneficial,” Dr. Marks explained. “In other words, a vaccine—even if you get the disease—could prevent you from dying of that disease, as we know the COVID-19 vaccines did because we have data on that.”

Dr. Offit noted that during the pandemic, people who were vaccinated were approximately 12 times less likely to be hospitalized or die than those who were unvaccinated (MMWR Morb Mortal Wkly Rep 2022;71[4]:132-138).

Mr. Kennedy’s use of the term “antigenic shift” in the X post claimed that the mRNA vaccines can lead to the mutations of SARS-CoV-2 seen during the pandemic. However, SARS-CoV-2 was evolving rapidly before any vaccine was developed, Dr. Offit noted. “We had the original Wuhan 1 strain that became the so-called D614G variant, which became the alpha variant, which became the delta variant, before we ever had widespread vaccination. This virus is perfectly capable of mutating on its own, without the pressure of antibodies induced by vaccination. And even as the virus mutated, the vaccine continued to work.”

Antigenic shift also does not occur in a virus like SARS-CoV-2, Dr. Offit explained. “Antigenic shift is a term that really is reserved for influenza because it requires a major reassortment event. It’s unique to segmented viruses. The SARS-CoV-2 virus does not have antigenic shift; it only has antigenic drift, if you will, and even that is too strong of a term. It does mutate, but not in that way.”

Dr. Offit compared the SARS-CoV-2 virus to measles, another single-stranded RNA virus. “We’ve had that vaccine since 1963, and it’s really never mutated away from antibody recognition,” he said. “Kennedy is wrong when he says that there’s any evidence that the vaccine became ineffective because it was inducing an immune response that was causing the virus to mutate. There is literally no evidence that this virus mutated away from antibodies induced by vaccination.”

The funding cuts rob scientific researchers and public health officials of one of the most valuable and rapidly responsive tools available to address future pandemics, Dr. Offit said. “Way back in 2002-2003, when SARS-CoV-1 raised its head in China, people like Barney Graham, who was then at the National Institutes of Health, started developing an mRNA vaccine against it. That virus never really emerged in this country, but their work generated a lot of information on how to make an mRNA vaccine against a coronavirus. So when SARS-CoV-2 came to the U.S., they were ready. And that’s what BARDA does. All of that now stops. There may never be an H5N1 bird flu pandemic in the U.S., for example, but now we will be less prepared if there is one.”

Dr. Marks warned that the United States is ceding its leadership in this field to other nations. “Unfortunately, if we don’t want to believe in thhe value of mRNA technology, those outside of the United States will take advantage of the truth and make sure that they use this technology to protect themselves. And we will be at a strategic disadvantage because of our unwillingness to accept scientific fact.”

—Marie Rosenthal, MS, contributed to this story.

The sources reported no relevant financial disclosures.