Cells use mRNA to build proteins, and after years of research, scientists learned how to harness this molecule to develop effective, safe and quick-to-make vaccines. Since the advent of this Nobel Prize-winning technology, a handful of mRNA vaccines have been approved in the United States — namely, COVID-19 and RSV shots. Vaccines still in development could someday protect against seasonal flu, bird flu, HIV and more.
But now, the U.S. federal government is slashing its investments in mRNA vaccines — a move that will immediately impact 22 projects totaling nearly $500 million, the U.S. Department of Health and Human Services (HHS) announced Tuesday (Aug. 5).
Some projects in late stages will be allowed to wrap up, but “no new mRNA-based projects will be initiated,” the statement said. The department will also cease “all mRNA-based equity investments” coordinated through its partner Global Health Investment Corp., a nonprofit that supports the development of public health technologies through venture capital.
Robert F. Kennedy Jr., HHS secretary and founder of the anti-vaccine group Children’s Health Defense, claimed in the statement that mRNA vaccines “fail to protect effectively against upper respiratory infections” and said that the HHS will shift to funding “safer, broader vaccine platforms.” These alternatives are later defined as whole-virus vaccines and unspecified “novel” technologies.
Per the statement, this retreat from mRNA vaccines will not impact “other uses of mRNA technology.” But “I can tell you that the industry doesn’t trust that,” said Jeff Coller, the Bloomberg distinguished professor of RNA biology and therapeutics at Johns Hopkins University, who has studied mRNA for more than 30 years. “Even though the cancellation was specific to infectious disease, it really was a shot across the bow to the entire industry.”
mRNA is useful for more than combating infectious diseases. It could potentially be applied as a cancer therapy, a vehicle to deliver gene-editing treatments into the body, a way to rein in autoimmune diseases like multiple sclerosis, or a treatment for the dangerous pregnancy disorder preeclampsia, for example.
Live Science spoke with Coller about the recent funding cuts and their anticipated impacts on the mRNA field and health of Americans.
Related: What are mRNA vaccines, and how do they work?
Nicoletta Lanese: Can you talk about how the HHS stance on mRNA vaccines had been shifting prior to Tuesday’s cuts?
Jeff Coller: It was clear early on, before Robert F. Kennedy was nominated for the position of secretary of HHS, that he was, first of all, a vaccine skeptic, and highly critical of mRNA-based vaccines, as well. His statements before his appointment included some things like, “The mRNA vaccines were some of the most dangerous medicines introduced into the human population.”
[After his appointment], one of the first things that he did was to dissolve the committee that oversees the procedures of vaccinations within the United States called ACIP [Advisory Committee on Immunization Practices], and he appointed new individuals to that committee. One of those includes an individual who is an mRNA skeptic: Robert Malone, who has claimed on TV and Joe Rogan that mRNAs are dangerous.
In addition to that, in about March of this year, there was an internal memo sent to NIH [National Institutes of Health] employees, asking them to disclose if they were working on mRNA vaccines, as well as to disclose who their colleagues were. This was made public and was published in journals like Science and was a warning sign that they were potentially going to target individuals associated with this type of research.
So we are already starting to feel that there was a growing anti-mRNA sentiment within the HHS, and then the cancellation of Moderna’s bird flu contract that happened about maybe six weeks ago was probably the first direct action of an mRNA program being canceled by the federal government. And now, what happened two days ago [was that] funding was canceled for 22 of these mRNA projects that were investigating various vaccines.
NL: Are you aware of the specifics of any of those projects?
JC: We do know of some clinical trials that were already underway [and were impacted], and this included influenza — which is, of course, the big one — as well as respiratory syncytial virus, or RSV; cytomegalovirus, which is often called CMV; Zika, Epstein-Barr virus; and hepatitis B.
NL: The HHS statement drew a line between mRNA vaccines and “other uses” of mRNA. Do you think that those other projects will be unaffected?
JC: Well, I can tell you that the industry doesn’t trust that. And the reason why I know that is that I’m one of the founders of the Alliance for mRNA Medicines. This is an organization of over 75+ members, many are biotech — small biotech, large biopharma, as well as major academic medical centers, including [Johns] Hopkins and Penn [the University of Pennsylvania] and the Mayo Clinic. We did a survey very early in the [Trump] administration to ask about some of these policy changes that were coming down from HHS. The overwhelming response from our membership was that they felt that the United States was becoming an unfriendly place for mRNA-based technology.
Even though the cancellation was specific to infectious disease, it really was a shot across the bow to the entire industry. It sent a chilling effect through the industry that basically makes everyone question, should we continue to invest in these programs within the United States?
The arguments that were made [by RFK Jr.] were vague and are not based on what is accepted in the scientific community. In fact, most of his statements are false. So, given that that decision was clearly made on nonscientific beliefs, then the industry is going to be scratching their head and thinking, “Well, maybe we should probably look elsewhere to develop our products, other countries.”
Not continuing to investigate the usage of a technology that has proven itself is completely reckless and puts America and Americans in harm’s way.
Jeff Coller, Johns Hopkins University
NL: One example I was thinking about was “cancer vaccines,” which are more of an immunotherapy. Do you think HHS will carve out an exception for those?
JC: We don’t know. And we’ve tried to move away from using the word “cancer vaccine” on purpose. We started referring to them as “cancer neoantigen therapies.” To start thinking about you changing your wordage because you’re worried about how the administration is going to perceive what it is you’re doing is alarming.
Many of these technologies that are being developed for cancer are still very early in research and development. These are still not even in the biotech space; a lot of them are still in the academic setting. If you’re an academic lab, are you really going to continue down this road if you are not going to be able to get funding? I personally know of investigators that are doing clinical trials on mRNA-based approaches for cancer who are scared — they’re actually scared to talk to reporters like you. They’re scared to even mention that they have mRNA-based medicines, because their patients will suffer if the funding gets cut off.
NL: Another example I was thinking of was gene editing, and specifically CRISPR-based treatments. How could those be affected?
JC: When CRISPR was discovered, gene editing had a huge promise of being able to cure rare genetic disorders. But the limitation of gene editing was that if you introduce a gene editor, you have to be able to stop it. You have to be able to go and correct the mutation, and then you have to stop that machinery from working because you don’t want it to overdo its job. If it does so, it’s going to continue to edit and edit and edit the genome, and then you have a problem.
What has now made gene editing possible in a human patient is mRNA. In the case of baby KJ [the first-ever recipient of a customized CRISPR treatment], the CRISPR technology was introduced as an mRNA. That is the critical feature that was necessary to get this to work. The beauty of the human body is that it makes mRNA and then it clears the mRNA; it gets it out. So by introducing the gene-editing technology as an mRNA, we could go in, get an effect for a very short period of time, and then let the body do what it normally does and get rid of it. So that was perfect to do on this little baby.
By undermining mRNA-based work, we’re potentially limiting the ability to do this true personalized medicine approach of gene editing that could save millions of people’s lives every year.
NL: How do you anticipate this divestment could affect pandemic preparedness in the U.S.?
JC: I actually think that these decisions were completely reckless in that regard and put America in significant harm’s way, in terms of our national defense.
Through Donald Trump’s leadership under Operation Warp Speed, we were able to identify a pathogen, have a sequence, make a possible vaccine, develop that in nine months, and deploy it to the American people in the next three months. That’s unparalleled in human history. The reason why we’re able to do that is because of the power of the mRNA platform, that it is so easy to develop and easy to produce at scale, and then easy to deploy to the greater population.
Traditional vaccines, meaning before the advent of mRNA vaccines, typically take between three to five years to develop. And you don’t even know if it will be efficacious. If you have a pandemic, you do need a technology that can be rapidly deployed. Not continuing to investigate the usage of a technology that has proven itself is completely reckless and puts America and Americans in harm’s way.
And the truth is that other countries recognize the power of mRNA vaccines and mRNA medicines and are doubling down on their investment — especially China. Quite frankly, if a pandemic comes out, we’re going to be caught asking China for their vaccines.
NL: Do you think this could also prompt “vaccine tourism,” in which Americans go abroad to get vaccinated?
JC: If there’s a pandemic, like what might happen with avian flu, and we’re not prepared, absolutely — if Canada has a vaccine, people are going to migrate north.
And you have to think about it even more broadly than that. The study that came from [Memorial] Sloan Kettering [Cancer Center] that showed such good efficacy on pancreatic cancer — if that research stops, and continues in Europe or in China and you’re diagnosed with pancreatic cancer, you’re going to go there. Right? So you can think about the different types of tourism outside of vaccine tourism, sort of medical tourism.
NL: From an industry standpoint, what could these cuts mean for mRNA developers?
JC: First of all, you have other countries that are trying to recruit American companies to their shores through incentives. And they’re trying to do the same with scientists through easy pathways to citizenship and grant and funding mechanisms. In addition to moving their brick-and-mortar operations overseas, these American companies will start developing drugs that are specific to other countries. There are viruses that are more resident in South America; the market in the United States just doesn’t make sense, but we could easily sell those drugs to Brazil, for example.
That’s what I think will happen in the short course. These companies will start making drugs and marketing them to other countries. But then, in the long term, they actually will move brick and mortar.
NL: Are there other impacts that you anticipate these cuts having?
JC: I think that this will certainly impact America’s leadership in biomedical discovery. We’re going to lose an entire generation of scientists through these types of actions.
Let’s not fool ourselves: mRNA is one of the three most important molecules in the body, with the other two being DNA and protein. It’s the intermediary between them. When the federal government sends a message that mRNA-based medicine and research is not wanted, you’re basically saying that there’s a whole branch of science that is no longer welcome within the U.S.
So if you’re a young individual thinking about going to graduate school and becoming a scientist to try and use your talents to improve human health, you may not do that. You may not do that in the United States, at least. So I think the United States is going to fall dramatically behind in its leadership in biotech.
We’re going to see, over the next five to 10 years, a significant brain drain, where other countries build up their infrastructure, and new scientists are not trained in the United States, and preexisting scientists flee.
NL: What’s something you hope the public understands about these funding cuts and mRNA?
JC: I think that most Americans don’t understand that mRNA is a natural substance, a natural part of your body. Every cell in your body has mRNA — thousands of copies of mRNA.
With mRNA-based medicines, we’re not doing something that is dangerous or reckless. What we’re doing as medical professionals is we’re actually taking advantage of a natural system that exists within your body and using your body to help itself. It’s really quite remarkable that we’re able to do this. All we are doing is taking advantage of that remarkable system that preexists.
This article is for informational purposes only and is not meant to offer medical advice.
