Bulwark Takes: FDA Reverses Decision About Moderna Flu Vaccine

Podcast: Bulwark Takes
Date: February 19, 2026
Hosts: Andrew Egger (Host), Jonathan Cohn (Policy Reporter)
Main Theme:
An inside look at the chaos and controversy around the FDA’s handling of Moderna’s mRNA-based flu vaccine approval, with context on how politics and skepticism about mRNA technology under Robert F. Kennedy Jr.'s administration are affecting vaccine policy and biotech innovation.

Episode Overview

The episode unpacks the extraordinary events surrounding the FDA’s initial refusal—and rapid reversal—regarding Moderna’s application for its new mRNA-based flu vaccine. Host Andrew Egger and policy reporter Jonathan Cohn discuss the unprecedented nature of the FDA's move, the underlying political dynamics, and broader chilling effects on vaccine innovation in the US under Health and Human Services Secretary Robert F. Kennedy Jr.

Key Discussion Points & Insights

1. Background: Why mRNA flu vaccines matter

• mRNA vaccines, pioneered during the COVID-19 pandemic, are seen as a transformative technology with potential for flu and other infectious diseases.
• Standard flu shots are effective but imperfect; mRNA offers hope for quicker adaptation to new flu strains (03:18).
• mRNA platforms can bypass issues inherent to egg-based vaccines, e.g., supply shocks from avian flu (04:23).

2. The Unprecedented FDA Turmoil

• Event timeline:
  • Moderna submitted an mRNA flu vaccine application to the FDA.
  • FDA announced it wouldn’t review the application, citing missing data from a specific trial—despite previously approving Moderna’s trial plan without that test (03:18–07:22).
  • This move was characterized as nearly "unheard of" — “For it to change its opinion at the last second, like that is basically unheard of.” (07:16, Jonathan Cohn).
  • Agency insiders and external reporting revealed the rejection came from Vinny Prasad, an RFK Jr. appointee, overruling FDA scientists.
• Political backdrop:
  • RFK Jr.—known for anti-mRNA vaccine views—is Health & Human Services Secretary and has been pressuring the vaccine approval process (02:01–03:13).
  • Senior FDA scientists were overruled in favor of more stringent mRNA skepticism.

3. Immediate and Broader Industry Fallout

• Industry alarm: Drug companies and stakeholders sounded alarms:
  • “How are we supposed to develop the drugs if we’re going to do what you told us to do—and then at the last minute, you’re going to pull the rug out from under us?” (07:39, Jonathan Cohn).
  • Signals instability and unpredictability for biotech investors.
• White House intervention:
  • After backlash and intervention from the White House, the FDA agreed to review the application after modifications (08:00).

4. The Reversal: What Changed?

• Moderna split its approval request into two populations: under 65 and over 65, targeting the latter for further study (08:16–09:11).
• Jonathan Cohn downplays the change:
  • “To me, this does not look like a major concession from Moderna…Where they have landed is where this process might have landed if they had taken the application in the first place. So I don’t really see this as a major concession from Moderna. I think this is chaos at the FDA.” (08:53–09:50)

5. The Influence of RFK Jr. & Broader Chilling Effect

• RFK Jr.’s anti-vaccine stance permeates agency decisions, leading to confusion and internal dissent.
• Chilling effects on research:
  • Loss of public funding for mRNA research and reduced CDC vaccine recommendations (2025/2026) have “created a headwind on vaccines.”
  • Investors and biotech companies are becoming wary:
    • “You look at this resistance to vaccines and then you add on the chaos, and they’re just not going to want to spend the money.” (13:37, Jonathan Cohn)
• Impact on future innovation:
  • Fears that “we lose out on innovations and new vaccines that really could have been helpful” (14:49, Jonathan Cohn).

Notable Quotes & Moments

• On FDA’s unprecedented move:
  • “For it to change its opinion at the last second, like that is basically unheard of.” (07:16, Jonathan Cohn)
• On industry reaction:
  • “How are we supposed to develop the drugs if we’re going to do what you told us to do—and then at the last minute, you’re going to pull the rug out from under us?” (07:39, Jonathan Cohn)
• On chilling effects across the vaccine industry:
  • “It is part of a much broader story…Kennedy pulled hundreds of billions of dollars in government support for research that was supposed to go to companies like Moderna to help them develop mRNA vaccines for future pandemics…Moderna has pulled back on some of its investments.” (12:00–13:10, Jonathan Cohn)
• On long-term consequences:
  • “You look at this resistance to vaccines and then you add on the chaos…and they’re just not going to want to spend the money…we lose out on innovations and new vaccines that really could have been helpful.” (13:37–14:52, Jonathan Cohn)
• On the weirdness of the current environment:
  • “There are sort of like degrees of…craziness and lunacy and chaos to all of these things… Is there a steel man case to be made for this thing that the FDA is doing? …Or is it just pure, like Robert F. Kennedy Jr.-style mania that is motivating these things?” (09:51, Andrew Egger)

Timestamps for Key Segments

• [03:18] — Why mRNA flu vaccines matter and the current state of flu shots
• [05:16–07:22] — How Moderna and the FDA coordinated on trial design, and why the FDA’s refusal was shocking
• [08:08] — Moderna’s “concession” and FDA about-face
• [09:51] — Context on RFK Jr.’s political approach and its effect on agency norms
• [11:57] — Chilling effects: R&D funding, investor signals, reduced recommendations, liability system fears
• [14:57] — Closing thoughts: the story isn’t over—expect more disruptions

Summary Conclusion

Andrew Egger and Jonathan Cohn paint a picture of regulatory instability at the FDA under RFK Jr., with the agency’s normal evidence-based processes being replaced by political interventions and skepticism toward mRNA technologies. The Moderna flu vaccine controversy isn’t just about a single drug: it is emblematic of a deeper uncertainty for the future of vaccine innovation, public health guidance, and America’s biopharma leadership. The hosts expect further disruption and promise ongoing coverage as these unprecedented changes unfold.

For continued updates on the vaccine approval saga and RFK Jr.’s influence on biotech policy, follow The Bulwark’s coverage on their website and newsletters.