It's going to become unnecessarily harder to develop and make new vaccines. I've witnessed firsthand the dynamic nature of the vaccine industry, especially during my tenure at Moderna. It's a rocky business that is dealing with a rapidly occurring negative shift.
During the COVID pandemic, companies navigated market uncertainty while rushing to develop, test, and manufacture vaccines. A big difference maker was a national demand and collective understanding of the public health need for vaccines -- we all wanted to get out of our homes and back to our daily lives. The corresponding purchase commitments those companies secured with unprecedented government partnership made it viable for them to step forward and produce vaccines in an otherwise uncertain marketplace.
That all feels like ancient history now as our nation's health officials impose new obstacles in the form of increased regulatory hurdles and misrepresentation of what exactly constitutes science. It starts with the very tropes these officials deploy, insisting on "gold-standard science" and parents "doing their own research."
But we have moved beyond mere words. Now, several developments are coalescing to create a significant degree of unpredictability in the vaccine marketplace. Recent administration actions signal increasing trouble and significant obstacles in getting vaccines onto the market.
In recent months, the foundation of America's vaccine enterprise -- development, regulation, and access -- has begun to erode. A series of quiet but seismic changes at the FDA and CDC should concern anyone who cares about public health.
The seismic shift began with the delay of the February meeting of the CDC's Advisory Committee on Immunization Practices (ACIP) and the publishing of disclosures of "conflicts" for ACIP members, an unusual move that could discourage qualified experts from serving. NIH research cuts have also been implemented, including a reduction in overhead support for research institutions, the elimination of grants related to vaccine hesitancy and pandemic-related studies, and grant review pauses.
Leadership at FDA's Center for Biologics Evaluation and Research (CBER) has also been destabilized. The departure of senior leaders, followed by the appointment of Vinay Prasad, MD, MPH -- a frequent critic of public health orthodoxy -- as its director, signals a marked shift in direction. The agency failed to meet critical deadlines, including the licensure decision for Novavax's COVID-19 vaccine. FDA Commissioner Marty Makary, MD, MPH, dismissed the delay, saying the agency must prioritize "gold-standard science."
Yet transparency has not been the hallmark of this new regime. In a striking departure from past practice, the FDA selected flu strains for the 2025-2026 vaccine without convening its external advisory committee for public deliberation. Meanwhile, the agency has shed more than 3,500 staff members, with implications for its scientific rigor and institutional memory.
In the span of 10 days, the administration shattered ordinary processes and procedures, blurring lines between the role of respective HHS agencies. Notably, on May 20, Makary and Prasad announced a new regulatory approach to COVID-19 vaccine approvals in the New England Journal of Medicine, shifting to a risk-based model. This change alters the FDA-approved indication, not through CDC and ACIP recommendations, but by agency fiat.
The forceful unilateral policymaking culminated in an odd video appearance with HHS Secretary Robert F. Kennedy Jr. flanked by the heads of FDA and NIH, with no HHS public health officials in sight. The leaders directly discouraged further vaccination of pregnant persons and children and announced it was superseding the recommendations of ACIP.
In parallel, the government has canceled key vaccine contracts, including one for Moderna's H5N1 vaccine, and is now requiring placebo-controlled trials for all new vaccine candidates -- regardless of feasibility, precedent, or deep ethical concerns.
Together, these decisions signal not just a policy shift, but a chilling retreat from the infrastructure that made the U.S. a leader in vaccine innovation and access. These shifts and the promotion of discredited safety concerns from the top not only make the already arduous task of creating and producing vaccines harder, but also erode public trust essential for widespread vaccine adoption.
Unpredictable and politically driven regulatory approaches cultivate an environment of enormous uncertainty for vaccine developers and manufacturers. These interconnected forces will eventually have a chilling effect on both public perception of the industry and the industry's willingness to stay in the game.
If the past is prologue, many vaccine manufacturers will give up the high costs and relatively low returns of vaccine market participation. In 1967, 26 manufacturers produced vaccines. That number dwindled to 17 in 1980 and 5 by 2004.
Consequently, we risk the forfeiture of the vaccines of today and tomorrow, potentially stripping our society of the tools that have for two and a quarter centuries successfully defended us against the scourge of deadly diseases.
Richard Hughes IV, JD, MPH, is an attorney and advisor in the biopharma sector, with a particular focus on vaccines. He was vice president of public policy at Moderna during the COVID-19 pandemic and teaches vaccine law at George Washington University.
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