This month, the US Department of Health and Human Services (HHS) announced a significant decision to cancel 22 contracts and investments totaling nearly $500 million as part of a “coordinated wind-down” of mRNA vaccine research. However, it’s important to note that some projects unrelated to mRNA or vaccines have also been affected by this decision.
Simultaneously, the HHS administration has quietly endorsed ongoing research into mRNA treatments for serious conditions such as cancer and genetic disorders. HHS Secretary Robert F. Kennedy Jr. has expressed skepticism towards mRNA vaccines. In May, he announced that HHS would no longer recommend mRNA Covid-19 vaccines for healthy children and pregnant women. That same month, he canceled a $590 million contract with Moderna, one of the key manufacturers of mRNA Covid vaccines, for a bird flu vaccine utilizing the same technology.
In a social media video, Kennedy justified the cuts by stating, “HHS has determined that mRNA technology poses more risk than benefits for these respiratory viruses.” This claim contradicts existing scientific evidence. Jonathan Kagan, an immunologist at Harvard Medical School and co-founder of Corner Therapeutics, which is developing mRNA treatments for cancer, challenges the misconception surrounding mRNA. He explains, “The major misconception is that mRNA is some voodoo thing that we are sticking into our body.”
Messenger RNA, or mRNA, is a natural molecule found in every cell in the body. It serves as a blueprint, instructing cellular machinery to produce specific proteins necessary for the body’s functioning and repair. Kagan likens mRNA to an app that enhances human health, emphasizing its potential in advancing medical science.
“The problem with mRNA is that the first clinical application was the most political thing on the planet,” Kagan notes, referring to the mRNA Covid vaccines developed during President Donald Trump's administration as part of Operation Warp Speed. These vaccines utilize mRNA to instruct cells to produce copies of the coronavirus spike protein, effectively stimulating the immune system to generate defenses against the virus. They played a critical role in reducing mortality and hospitalization rates during the pandemic.
While the mRNA Covid vaccines boast a high safety profile, they have been associated with rare cases of heart inflammation, particularly in boys and young men. In June, the US Food and Drug Administration (FDA) approved new labeling for the mRNA Covid vaccines from Moderna and Pfizer, highlighting this risk.
Research into mRNA vaccines has been ongoing for many years, and the technology’s rapid deployment during the pandemic was due to its faster manufacturing capabilities compared to traditional vaccine development methods. The success of mRNA Covid-19 vaccines led to increased government investment in mRNA technology.
The recent contract cancellations announced on August 5 were part of a program under the Biomedical Advanced Research and Development Authority (BARDA), an agency within HHS responsible for developing medical countermeasures against pandemics and other public health threats. Among the canceled projects were those unrelated to mRNA or vaccine development.
One affected recipient, Tiba Biotech, had a $750,000 contract with BARDA intended to develop an RNAi-based therapeutic for H1N1 influenza, also known as swine flu. RNA interference (RNAi) involves small RNA sequences that can inhibit the production of specific proteins, a method that has been well-studied and has resulted in several approved RNAi-based medications.
The cancellation of the contract surprised Tiba, which received a stop-work order on August 5 without any reference to the wind-down of BARDA’s mRNA vaccine development initiatives. “Our project does not involve the development of an mRNA product and is a therapeutic rather than a vaccine,” stated Jasdave Chahal, Tiba’s chief scientific officer.
Another canceled contract included a $750,000 award to Emory University aimed at converting an mRNA-based antiviral treatment for flu and Covid into an inhaled, dry powder formulation. This project did not involve vaccine development either, leading to questions about the rationale behind the cuts. An Emory spokesperson remarked, “Unfortunately, we don’t have much insight to offer on the grant cancellation.”
These cuts align with Kennedy’s desire to deprioritize research into infectious diseases, raising concerns among experts about the potential vulnerability of the US to future pandemics. Despite this scaling back of RNA-related infectious disease research, the administration has shown enthusiasm for some non-Covid research involving mRNA.
Earlier this year, President Trump announced a collaboration between OpenAI, Oracle, and SoftBank called Stargate, which aims to invest up to $500 billion in AI infrastructure, including the potential for personalized mRNA-based vaccines for cancer.
In an August 12 op-ed in The Washington Post, Jay Bhattacharya, the director of the National Institutes of Health, acknowledged the potential of mRNA technology. He stated, “I do not dispute its potential. In the future, it may yet deliver breakthroughs in treating diseases such as cancer, and HHS is continuing to invest in ongoing research on applications in oncology and other complex diseases.”
Unlike Kennedy, Bhattacharya does not believe that mRNA vaccines have caused mass harm; instead, he attributes the cessation of mRNA vaccine research to a loss of public trust—a viewpoint that contrasts with Kennedy’s stance.
Interestingly, mRNA may find greater acceptance in the treatment of severe genetic disorders. Earlier this year, the FDA approved a customized gene-editing treatment for a patient named KJ Muldoon, an infant with a rare and life-threatening liver disease. This groundbreaking treatment, developed in just six months, utilizes mRNA to deliver gene-editing components directly to the liver.
FDA Commissioner Marty Makary praised the achievement, calling it “kind of a big win for medical science.” The researchers behind this innovative treatment plan to extend their approach to more patients and have recently engaged with the FDA regarding a clinical trial proposal. “The FDA was very positive about the proposal and effectively gave us the green light to proceed with our work,” stated Kiran Musunuru, a professor of translational research at the University of Pennsylvania and Children’s Hospital of Philadelphia.
As the team prepares for another meeting with the FDA, they aim to discuss broadening their platform concept beyond a singular disease or gene, potentially addressing a wider array of genetic disorders. “We’ll see how that goes,” Musunuru added.
