RFK Jr. Is Supporting mRNA Research—Just Not for Vaccines
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This month, the US Department of Health and Human Services announced that it was canceling 22 contracts and investments worth nearly $500 million as a part of a 'coordinated wind-down' of mRNA vaccine research. Yet some projects that do not involve mRNA or vaccines have been caught up in the purge. At the same time, the administration has quietly endorsed research into mRNA treatments for cancer and genetic disorders.
HHS secretary Robert F. Kennedy Jr. has long been suspicious of mRNA vaccines, and in May he announced that HHS would no longer recommend mRNA Covid-19 vaccines for healthy children and pregnant women. The same month, he canceled a $590 million contract with Moderna, one of the mRNA Covid vaccine manufacturers, for a bird flu vaccine based on the same technology. In a video on social media, he justified the latest cuts by saying 'HHS has determined that mRNA technology poses more risk than benefits for these respiratory viruses,' which contradicts the scientific evidence.
'The major misconception is that mRNA is some voodoo thing that we are sticking into our body, that it's a magic molecule from Mars,' says Jonathan Kagan, an immunologist at Harvard Medical School and cofounder of Corner Therapeutics, which is developing mRNA treatments for cancer.
Short for messenger RNA, mRNA is a molecule found naturally in every cell in the body. It provides instructions to cell machinery to make certain proteins and is used constantly by the body to run and repair itself. Kagan likens mRNA to an app for human health. Scientists have figured out how to make synthetic versions of the molecule that can be programmed to make different kinds of proteins. This tailored mRNA can then be delivered to people to address various diseases.
'The problem with mRNA is that the first clinical application was the most political thing on the planet,' says Kagan, referring to the mRNA Covid vaccines. 'Therefore the disease got muddied in the technology.'
Developed and authorized during President Donald Trump's first administration as part of Operation Warp Speed, the mRNA Covid vaccines use the molecule to direct cells to produce copies of the coronavirus spike protein, stimulating the immune system to create defenses against the virus. The shots were instrumental in reducing deaths and hospitalizations during the pandemic, and while they have a very high safety profile, they have been known to cause rare cases of heart inflammation in boys and young men. In June, the US Food and Drug Administration approved new labeling for Moderna's and Pfizer's mRNA Covid vaccines to emphasize this risk.
Research into mRNA vaccines had been ongoing for years, and during the pandemic the technology was used because it allowed for faster manufacturing compared to traditional vaccine development methods. The versatility of mRNA led to an explosion of interest in harnessing it against a range of other diseases, both in vaccines and therapeutics.
After the success of the mRNA Covid-19 vaccines, the US government invested more heavily in mRNA technology. The canceled contracts announced on August 5 were part of a program under the Biomedical Advanced Research and Development Authority (BARDA), the agency within HHS tasked with developing medical countermeasures against pandemics and other public health threats. Among the projects canceled are some that weren't working with mRNA or on vaccine development.
One of the targeted recipients, Tiba Biotech, had a $750,000 contract with BARDA that was slated to end October 30. The company was developing an RNAi-based therapeutic for H1N1 influenza, also known as swine flu. RNAi is short for RNA interference and refers to small pieces of RNA that can shut down the production of specific proteins. The approach has been well studied, and several RNAi-based drugs are on the market. The first was approved in 2018 to treat nerve damage caused by a rare disease called hereditary transthyretin-mediated amyloidosis.
The contract cancellation came as a surprise to Tiba, which received a stop-work order on August 5 that did not reference the wind-down of BARDA's mRNA vaccine development activities. 'Our project does not involve the development of an mRNA product and is a therapeutic rather than a vaccine,' said Jasdave Chahal, Tiba's chief scientific officer, via email.
Government contracts often include specific milestones that contractors must achieve to receive funding and move forward with their projects. Tiba says its project had met its goals so far and was near completion.
Also among the canceled contracts was a $750,000 award to Emory University to convert an mRNA-based antiviral treatment for flu and Covid into an inhaled, dry powder formulation. The project did not involve the development of a vaccine. 'Unfortunately, we don't have much insight to offer on the grant cancellation,' Emory spokesperson Brian Katzowitz told WIRED in an email.
The cuts are consistent with Kennedy's desire to deprioritize research into infectious diseases, although experts have warned that the cuts could leave the US more vulnerable to future pandemics.
Despite its scaling down of RNA-related infectious disease research, the administration has expressed enthusiasm about some non-Covid research involving mRNA.
In January, shortly after taking office, President Trump announced a joint venture by OpenAI, Oracle, and SoftBank called Stargate to invest up to $500 billion for AI infrastructure. At the time, Oracle CEO Larry Ellison talked up the potential for AI to make personalized mRNA-based vaccines for cancer.
In an August 12 op-ed in The Washington Post, National Institutes of Health director Jay Bhattacharya acknowledged the promise of mRNA. '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,' he wrote.
Unlike his boss, Bhattacharya says he does not believe the mRNA vaccines have caused mass harm. But he says the reason for stopping mRNA vaccine research is because the platform has lost public trust—a rationale that deviates from Kennedy's.
Yet mRNA may be more accepted when it comes to treating very sick patients with genetic disorders.
Earlier this year, regulators at the FDA greenlit a customized gene-editing treatment for an infant named KJ Muldoon with a rare and life-threatening liver disease. Created in just six months, it uses mRNA to deliver the gene-editing components to his liver. It was the first time a customized gene-editing treatment was used to successfully treat a patient.
In June, FDA commissioner Marty Makary praised the achievement on his podcast, calling it 'kind of a big win for medical science,' and at an FDA roundtable Makary said the agency will continue to facilitate the regulatory process for these types of products.
The researchers behind the custom gene-editing treatment plan to use the same approach for more patients and recently met with the FDA about a clinical trial proposal. 'The FDA was very positive about the proposal and effectively gave us the green light to proceed with our work,' says Kiran Musunuru, professor for translational research at the University of Pennsylvania and Children's Hospital of Philadelphia.
The team has another meeting with the FDA in a month or two to discuss extending the platform concept beyond a single disease or single gene to a broader group of disorders. 'We'll see how that goes,' he says.
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