Can America's Retreat On mRNA Be Europe's Opportunity?

By Ron Lanton III, Esq., Lanton Law PLLC

With the unprecedented success of mRNA vaccines during the pandemic, it almost felt as though mRNA technology was about to enter a “golden era” where new solutions using this platform would be found to finally address costly and devastating diseases that had been wreaking havoc in many countries. Unfortunately, the steadfast rising skepticism in the U.S. about vaccines has caused a drastic change on mRNA from the U.S. Department of Health and Human Services (HHS).

On Aug. 5, 2025, the HHS announced that the Biomedical Advanced Research and Development Authority would begin a coordinated wind-down of its mRNA vaccine development activities.¹

For now, the development of mRNA faces a key inflection point. With signs pointing in the direction of an “innovation retreat” for now on vaccines in the U.S., will this cause another power like the European Union (EU) to pick up the reins of leadership and continue to explore advancing the possibilities that mRNA technology can potentially unlock? In this article, I will briefly explore what mRNA technology is, how the pandemic leapfrogged mRNA to the policy forefront, and what’s next for mRNA in an uncertain policy world.

Origins Of mRNA

The first question to ask is what is mRNA? According to the National Human Genome Research Institute:

“Messenger RNA (abbreviated mRNA) is a type of single-stranded RNA involved in protein synthesis. mRNA is made from a DNA template during the process of transcription. The role of mRNA is to carry protein information from the DNA in a cell’s nucleus to the cell’s cytoplasm (watery interior), where the protein-making machinery reads the mRNA sequence and translates each three-base codon into its corresponding amino acid in a growing protein chain."¹

mRNA Skepticism

While the mRNA technology has been around, COVID-19 finally allowed the promise of mRNA to shine via Operation Warp Speed. As the rest of the world coalesced to find a cure during the early days of the deadly pandemic, Operation Warp Speed — a U.S. federal initiative to accelerate a cure — poured billions of dollars into research, manufacturing, and distribution. This unprecedented public-private partnership compressed what normally takes a decade into less than a year. By December 2020, the FDA had granted Emergency Use Authorizations for the Pfizer-BioNTech and Moderna vaccines, opening the door to mass vaccination campaigns that would save millions of lives globally.

As the world began to recover, the U.S. started to witness a slow-moving policy backlash on vaccines. The National Defense Authorization Act in late 2022 saw Congress repeal the COVID-19 vaccine mandate for military personnel. On the state level, Mississippi in 2023 saw that a federal judge ordered the state to allow religious exemptions to school vaccine mandates. West Virginia followed with similar policy in 2025, while Idaho in April 2025 enacted SB1210, titled the Medical Freedom law, that prohibited vaccine mandates in schools, businesses, and government bodies.

The appointment of Robert F. Kennedy Jr. by President Trump as the next HHS secretary set the stage for a significant policy shift in light of what had been accomplished. While Kennedy denied that he was anti-vaccination, on several occasions he repeated debunked claims about vaccine harms. After promoting several vaccine skeptics within HHS and reconstituting the Advisory Committee on Immunization Practices, Kennedy’s next move was predictable yet shocking. On Aug. 5, 2025, HHS announced the “beginning of a coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA), including the cancellation and de-scoping of various contracts and solicitations. The decision follows a comprehensive review of mRNA-related investments initiated during the COVID-19 public health emergency.”¹

The wind down included the following steps:

• Termination of contracts with Emory University and Tiba Biotech.
• De-scoping of mRNA-related work in existing contracts with Luminary Labs, ModeX, and Seqirus.
• Rejection or cancellation of multiple pre-award solicitations, including proposals from Pfizer, Sanofi Pasteur, CSL Seqirus, Gritstone, and others, as part of BARDA’s Rapid Response Partnership Vehicle (RRPV) and VITAL Hub.
• Restructuring of collaborations with DoD-JPEO, affecting nucleic acid-based vaccine projects with AAHI, AstraZeneca, HDT Bio, and Moderna/UTMB.

Opportunity For Europe

While the new U.S. policy stance takes shape and mRNA stands at a crossroads, what is the EU’s viewpoint on this matter? Policy development in the EU is scant. In the EU, mRNA products are not classified uniformly as they are in the U.S.

However, the EU has taken steps to advance mRNA policy. On Jan. 7, 2025, the European Pharmacopoeia Commission officially adopted three new general monographs for mRNA vaccines, which were published in late July: mRNA-LNP vaccines for human use (5.36) mRNA active substances for vaccine production (5.39) DNA templates for preparing mRNA substances (5.40).

Additionally, on March 31, 2025, the European Medicines Agency released draft guidance on the quality of mRNA vaccines for public consultation. The consultation period is open until Sept. 30, 2025.

With the EU and others around the world relying on the U.S. for innovation and defense as part of the post WWII world order, the reelection of President Donald Trump and his “America First” policy stances are creating an innovation vacuum for issues like mRNA. With the world witnessing more extreme climate changes, new diseases are going to emerge, which will likely need mRNA technology to solve these new threats.

Unfortunately, the EU does not have the luxury of time. While the EU could increase its efforts to be a co-leader in this space with the U.S., overtaking the U.S. would take coordinated efforts in drawing capital, regulatory speed, success in late-stage trials, and cooperation among healthcare leaders, such as BioNTech, ROVI, Sanofi, CureVAC, and others. To date, there has not been a need to fast track the EU’s clout in innovative fields like healthcare or technology. However, with the eclipsing of world cooperation by the U.S., the EU may have no choice. When a new power rises, the road is never clear, but history has taught us that innovation as old as history itself will always continue. The questions are: when and how?

References

1. HHS Winds Down mRNA Vaccine Development Under BARDA, August 5, 2025 Press Release https://www.hhs.gov/press-room/hhs-winds-down-mrna-development-under-barda.html
2. National Human Genome Research Institute; Messenger RNA, August 10, 2025 https://www.genome.gov/genetics-glossary/Messenger-RNA-mRNA

About The Author:

Ron Lanton has over 25 years of experience focused on government affairs and legal affairs, including 20 years dedicated to the healthcare sector. He is currently a partner at Lanton Law and the president of Lanton Strategies. He has been an executive director and senior counsel for a national boutique healthcare law firm. Prior to this, he founded the healthcare government affairs and lobbying firm True North Political Solutions. At True North, he lobbied and provided strategic consulting for retail/specialty pharmacies, HME, compounders, home infusion, and device stakeholders throughout the country. Prior to creating True North, Lanton created a government affairs department for a national wholesale distributor and consulted at a greater Washington, D.C.,-area government affairs firm. He frequently consults with investors on issues related to the healthcare and technology sectors. Lanton is admitted to practice in Illinois, District of Columbia, New Hampshire, New York, Massachusetts, and Connecticut.