Reclaiming mRNA's Story: How U.S. Policy Upheavals Are Pushing Us To Adapt
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
September was a busy month for me at Advancing RNA. I kicked off September with a whirlwind trip to Boston for the RNA Leaders conference, followed immediately by a trip to San Diego for the Alliance for mRNA Medicines ASCENT conference. Throughout the collective two weeks of conference sessions, my brain was delightfully inundated by all-things RNA, be it development, manufacturing, delivery, or regulatory policy oriented. (Ok, and maybe the occasional Old Fashioned or creatively named [“I Didn’t Text You Tequila Did”] cocktail.)
But now that I’ve returned and had a chance to review my many notes from each show, there were two conversations about the current state of our industry that rose to the top — and I dare say you’ll know why. It hasn’t been the easiest time to be in the mRNA therapeutics industry in 2025. It’s one thing to face the normal albeit painful inflection points that challenge our ability to raise funds and to demonstrate mRNA’s clinical reality. It’s a whole other ball game to be facing these growing pains while also attempting to reclaim/reset the mRNA narrative in the wake of scientific misinformation and harmful U.S. government policies.
I’d like to believe everyone reading Advancing RNA already knows that mRNA is the greatest. So, this article isn’t going to outline why the U.S. government’s current efforts to disparage mRNA are harmful. Rather, I’d like to focus on how these policies are impacting our industry in both positive and negative ways — starting with a few takeaways I gleaned from a discussion at RNA Leaders. (Part 2 will delve into takeaways from the Alliance for mRNA Medicines’ ASCENT conference — stay tuned.)
The Impact So Far: What We Need To Know
As we already know (and many other publications have covered), the ominous writing on the wall started to become legible earlier this year when the HHS cancelled Moderna’s contracts for bird flu and other vaccines. This eventually culminated in HHS’ decision to eliminate all mRNA vaccine development under BARDA.
There are a lot of ways these policies are misguided, both from an innovation and biosafety standpoint. But as we’ve also worried and/or felt, such efforts have a corrosive effect on our industry’s general infrastructure. As Danaher’s Sadik Kassim went on to explain, the lack of predictability in equipment and consumable orders/manufacturing services makes it much more complicated for service firms to predict market demand for the next three years.
“We’re seeing a lot of companies out there that have enabling technologies — really interesting capabilities — but they’re not getting venture investment or strategic investment. So, I think one impact here is that the current lack of market predictability will pause investments in the enabling infrastructure for the next wave of innovation — at least domestically,” Kassim explained.
While the dynamics in the U.S. are destabilizing (to say the least), Kassim pointed out that other countries have taken this as an opportunity to charge forward. For example, the U.K. continues to bolster its biomedical innovation infrastructure, announcing the Biomedical Catalyst in June 2025. This program is designed to help fund small and medium-sized businesses develop therapies (including RNA therapies), medical devices, and digital health solutions.
Given Australia’s ongoing work with its “RNA Blueprint”, it should come as no surprise that the nation is not squeamish about continuing to move RNA science forward. As Leavitt Partners’/AMM’s Clay Alspach explained, “At AMM we were having discussions about the August 5 cancellations, and we had several Australian members join. It was 1 AM Australian time, but they joined and said, ‘We wanted to come on because, though we’re disappointed, we want to let you know that we’re with you, and we will figure a way out of this.’”
As Alspach continued, “The rest of the world is rolling out the red carpet and is moving forward with this technology. That’s been incredibly inspiring and helpful during this process.”
From Abstract To Concrete: Shifting The mRNA Narrative
Short of renaming Alliance for mRNA Medicines “Citizens for Natural Polymers” (shout out to the RNA Leader attendee who came up with that joke), there were two strategies this panel and the audience brainstormed together to keep the industry progressing as we strive to get our policy ducks in a row.
If there is one thing that we’ve learned in the past few months, we’re no longer capable of making progress simply by emphasizing the success we had in rolling out the COVID vaccines. Now that the COVID narrative has unfortunately become skewed with the political, we need to shift our narrative, making the currently abstract therapeutic promise of mRNA into real, tangible evidence. A great example of this in recent months was the Baby KJ story.
“This took the potential of mRNA to reality,” Alspach said. “This story resonated with the regulatory officials, in particular. So, when the FDA hosted a roundtable, we had RFK Jr., Dr. Oz, and Marty Makary all emphasizing that they want to enable a framework that allows for more Baby KJs.”
To do so will, of course require the acknowledgement that Operation Warp Speed is not synonymous with mRNA vaccines; it was also how we developed the infrastructure to be able to treat Baby KJ. But overtime, we are also going to need more stories like these that clearly demonstrate the benefit of mRNA medicines.
“One of the issues on the vaccine side is that the positive effects were unseen,” one audience member added. “The baby KJ story is visually striking.”
Over the years, we’ve all seen the videos on social media of kids being able to see or hear their parents for the first time or being able to take their first steps after a groundbreaking treatment. Likewise, in the ATMP space broadly, we’ve seen entire movements and organizations launched following a patient’s successful treatment — think, for example, of The Emily Whitehead Foundation, Victoria Gray (the first CRISPR patient), or Dana-Farber Cancer Institute’s “The Jimmy Fund,” named after the first boy saved from cancer by Dr. Farber.
“I think once a therapy becomes real and benefits a patient and a patient’s family, the narrative around mRNA will change naturally,” Alspach said. “However, it’s going to be a challenge the next couple of years to get us there.”
A Collection of 50 Countries: Turning Federal Censure Into State-Level Opportunity
In addition to making the abstract more concrete, it’s worth remembering that this isn’t the first time we’ve ever seen restrictions, bans, or censure on certain types of research. As Kassim reminded us, under the Bush administration in 2001, there was a policy enacted that prohibited federal funding to embryonic stem cell research. This policy was revoked when Obama took office in 2009. However, what seemingly could have had a chilling effect ultimately led to states taking a leading role in striving to attract R&D and investment in this area. For example, such prohibitions at the federal level led to the founding of the California Institute for Regenerative Medicine and billions in in funding for stem cell research.
“Based on history, I would predict that we’re going to see more regionalization in terms of innovation and investment,” Kassim said. “We already have an alliance between California, Washington, and Oregon around vaccine mandates. There’s potential to do that on the East Coast, as well. So, I think the U.S. is really a collection of 50 countries — it’s not one country.”
There are many more insights to come on what we should be considering, embracing, celebrating, and continuing to do despite these challenges. Stay tuned for part 2 which will share key takeaways from a similar discussion that occurred on stage at the AMM ASCENT conference.