HHS scraps further work on life-saving mRNA vaccine platform

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In what experts say will hobble pandemic preparedness, US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. yesterday announced the dismantling of the country's mRNA vaccine-development programs—the same innovation that allowed rapid scale-up of COVID-19 vaccines during the public health emergency.

The Biomedical Advanced Research and Development Authority (BARDA) is terminating 22 mRNA vaccine-development contracts totaling just under $500 million, including an award to Moderna/University of Texas Medical Branch for a vaccine against the H5N1 avian flu now sweeping the world. That grant was terminated in late May.

Contracts awarded to Emory University and Tiba Biotech were cancelled, and agreements with Luminary Labs, ModeX, and Seqirus have been scaled back.

Proposals from firms such as Pfizer, Sanofi Pasteur, CSL Seqirus, and Gritstone that were part of BARDA's Rapid Response Partnership Vehicle and VITAL Hub have been rejected or cancelled, and collaborations on nucleic-acid–based vaccines between the Department of Defense and AstraZeneca, HDT Bio, and Access to Advanced Health Institute have been restructured.

"While some final-stage contracts (e.g., Arcturus and Amplitude) will be allowed to run their course to preserve prior taxpayer investment, no new mRNA-based projects will be initiated," the HHS press release said. "HHS has also instructed its partner, Global Health Investment Corporation (GHIC), which manages BARDA Ventures, to cease all mRNA-based equity investments."

Picking 'the least desirable technology'

Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, publisher of CIDRAP News, calls RFK's decision one of the worst decisions he's seen in 50 years of public health preparedness work. "mRNA technology could save us in the next pandemic," he said.

This is because flu-vaccine manufacturing capacity using the standard method of growing the virus in chicken eggs is much slower than mRNA production; it would take 14 months to make enough vaccine for only about 2 billion people—far short of the 8 billion needed for global coverage. But mRNA technology could manufacture enough for everyone within 1 year, Osterholm said.

This sets back vaccine science by a decade.

Andrew Pekosz, PhD

Andrew Pekosz, PhD, professor and vice chair at Johns Hopkins University, said on X that while mRNA vaccine technology isn't perfect, "it's a critical improvement over many existing vax platforms. This sets back vaccine science by a decade."

Rather than mRNA vaccines, which Secretary Kennedy claimed collapse after a single mutation, he is turning to whole-virus vaccines, a long-discredited platform, Peter Hotez, MD, PhD, professor and dean of the National School of Tropical Medicine at Baylor College of Medicine, said on X.

"First, it’s unreliable bc [because] you never know what viruses will grow in eggs or cell lines," he said. "You need a high titer [concentration] of virus. Second, two of our nation’s most troubling adverse vaccine reactions occurred using this approach."

Hotez cited two examples of whole-virus vaccine failures: a 1960s formalin-inactivated RSV vaccine that resulted in 80% of child recipients being hospitalized for severe respiratory disease and two dying, and a 1976 swine flu vaccine associated with increased cases of Guillain-Barre syndrome.

"Why does he pick the least desirable technology?" Hotez asked.

Scientists are skeptical of whole-virus vaccines for good reason, Osterholm explained: "That this is going to provide perfect protection is absolutely ridiculous," he said. On the other hand, he noted, mRNA vaccines are backed by solid, publicly available evidence.

Move weakens national security

On X, Chris Meekins, former deputy assistant secretary for preparedness and response at HHS, said, "Ending BARDA’s investment in mRNA technology creates a national security vulnerability. These tools serve as a deterrent to prevent other nations from using certain biological agents. The speed of the technology to create new biodefense capabilities is a national security asset."

In an HHS video released yesterday on Fox News, Kennedy said that after consulting with experts from the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), he decided to block further mRNA vaccine development because they "don't perform well against viruses that infect the upper respiratory tract."

Hotez said that Kennedy's statement shows how "untethered from reality he has become." On X, he wrote, "I doubt he listened to experts. It’s [the] rhetoric of wellness ideologues who deny the benefits of mRNA vaccine technology in saving 3.2 million American lives in the pandemic."

Osterholm put it this way: "There was no factual basis to what he said yesterday. He comes across as an authority on vaccines, and he's not."

Jerome Adams, MD, former US surgeon general, said on X that he's tried to remain "objective and non-alarmist in response to current HHS actions, "but quite frankly, this move is going to cost lives."

A 'fundamental misunderstanding of immunology'

Jake Scott, MD, an infectious disease physician and clinical associate professor at Stanford University, pointed out on X that the Centers for Disease Control and Prevention's (CDC's) own data show that 53 times more unvaccinated people than their vaccinated counterparts died of COVID-19 in 2021.

The idea that mRNA vaccines 'failed' because they didn't block all respiratory infections reveals a fundamental misunderstanding of immunology.

Jake Scott, MD

"Like so many of us on the frontlines in 2020 & 2021, I witnessed the staggering impact of mRNA vaccines," he wrote. "Deaths plummeted. It's hard to convey how profound this was."

"The idea that mRNA vaccines 'failed' because they didn't block all respiratory infections reveals a fundamental misunderstanding of immunology," Scott added. "No vaccine for flu, RSV [respiratory syncytial virus], or COVID has ever done that. The goal is preventing severe disease, and mRNA vaccines delivered. They saved millions of lives and gave us a platform that can be rapidly updated as new threats emerge."

Kennedy didn't name the "risks" of mRNA vaccines that outweigh the benefits or what his decision means for already-approved mRNA vaccines, Osterholm said. "Is he going to leave the currently approved vaccines on the market?" If harms existed, Osterholm added, "why did the FDA approve COVID vaccines to begin with? It just creates this gap in the mind of the consumer that is not factually based. It's an irresponsible thing."

Yesterday on Substack, Paul Offit, MD, a physician and director of the Vaccine Education Center at Children's Hospital of Philadelphia, warned that "sometime in the next couple of months, RFK Jr. will hold up a bogus 'study' that he will claim proves that aluminum adjuvants in vaccines cause autism or some other chronic disorder."

"Then he will manipulate the VICP [Vaccine Injury Compensation Program] to make vaccines less available, more expensive, and more feared," he added. "His action won’t lessen the incidence of autism; it will only increase the incidence of suffering and hospitalization from vaccine-preventable diseases.

"Buckle up."