Podcast Summary: The Journal – "The Flu Shot Drama at the FDA"

Date: February 18, 2026
Hosts: Jessica Mendoza (A), Liz Eslie White (B, WSJ health policy reporter)
Notable Guests/Quotes: Dr. Vinay Prasad (D, FDA), Pierre Fabre spokesperson, White House/Health and Human Services officials

Episode Overview

This episode dives deep into the recent controversy surrounding the FDA’s handling of Moderna’s new mRNA flu vaccine application, highlighting the shifting regulatory landscape at the FDA, leadership challenges, and political influences affecting drug approvals. Host Jessica Mendoza interviews health policy reporter Liz Eslie White to break down the agency’s tumultuous decisions, the influence of top officials, and the broader implications for the pharmaceutical industry.

Key Discussion Points & Insights

1. A Severe Flu Season and the Promise of mRNA Vaccines

• Flu Severity: The U.S. has faced at least 23 million cases and 19,000 deaths since October, marking one of the worst flu seasons in recent history. [00:23]
• mRNA Innovation: Moderna, known for its COVID-19 mRNA vaccine, is developing a next-generation mRNA-based flu shot.
  • Benefit: mRNA technology offers faster adaptability to changing flu strains, unlike the slow, globally coordinated "guessing game" of current flu vaccines. [04:23–05:47]
  • Liz Eslie White: "The promise of MRNA technology is that you can do that with a little bit quicker turnaround...especially in a flu pandemic scenario, to get a vaccine out much more quickly." [05:14]

2. The FDA’s Unexpected Refusal to Review Moderna’s Application

• Initial Rejection: The FDA surprised many by refusing to even review Moderna's mRNA flu shot application, despite previously agreeing with Moderna's trial design. [01:44]
  • Liz Eslie White: "The FDA had already signed off on the way that Moderna was looking at studying the flu shot...Moderna really felt like the FDA was kind of changing the rules of the game during the game." [01:44]
• Regulatory Shift: Under the Trump administration and Health Secretary Robert F. Kennedy Jr., FDA standards for vaccine approval were tightened, demanding full clinical trials (randomized-controlled) over quicker antibody response studies. [06:32]

3. Key Players: Dr. Vinay Prasad and a Changing FDA

• Dr. Vinay Prasad:
  • Head of vaccines at FDA, known for sharp critiques of the agency and skepticism toward mRNA vaccines.
  • Demanded Moderna test its shot against a higher-dose flu vaccine, finding Moderna’s trial design insufficient. [08:10]
  • Decision sparked internal uproar—staff met for over an hour to object to his refusal. [08:37]
• Prasad’s Background:
  • Emerged as a “Covid firebrand,” often critical of public health authorities and pandemic-era policies. [09:45–10:53]
  • "The FDA has failed the American people. You fail the American people every day. You allow this product to be pushed without knowing who actually benefits." – Dr. Prasad [10:24]

4. Broader Fallout and Agency Turmoil

• Prasad’s Controversial Tenure:
  • Clashes with other FDA and Trump officials, including public disputes (e.g., with Laura Loomer).
  • Dismissed and rehired within weeks; persistent complaints about his working style and absenteeism (taxpayers pay $65,000/year for his commute from San Francisco). [12:01–12:29]
• Inconsistent Policies for Rare Disease Drugs:
  • Despite public support for rare disease drug development, Prasad's division issued decisions that discouraged companies and reversed previous agency guidance. [13:40]
  • Example: French company Pierre Fabre faced a surprise rejection after believing they had fixed earlier issues. Days after rejecting their single-arm trial, Prasad publicly praised such trial methods, frustrating industry watchers. [14:32]
    • "We are surprised and deeply disappointed." – Pierre Fabre spokesperson [14:50]

5. Politics, Process, and a Partial Reversal

• White House Involvement:
  • Following internal and political consultations, the FDA reversed its stance and will now review Moderna’s application.
    • "This change of heart came from the FDA after discussions...with White House and Department of Health and Human Services officials." – Liz Eslie White [15:20]
  • A White House spokesperson denied orchestration. [15:33]
• What’s Next for Moderna’s Flu Shot:
  • The vaccine could debut as soon as the 2026–2027 flu season if approved. The decision is expected by August 5. [15:44]
  • FDA Commissioner Marty Makary hinted approval is possible. [15:44]
• Climate of Uncertainty:
  • Turnover and reversals at the FDA have led to anxiety in biotech—especially among rare disease and vaccine developers.
  • “They've had five leaders of their drug division over the last year, which is unprecedented turmoil.” – Liz Eslie White [17:01]

6. A Divided Sector and the Road Ahead [17:24–end]

• Some in pharma prefer the new, tougher FDA approach; others are more worried about drug pricing than regulatory flip-flops.
• FDA spokesperson: Agency reforms are “successful and broadly popular.” [17:24]

Notable Quotes & Timestamps

• "Moderna really felt like the FDA was kind of changing the rules of the game during the game."
  – Liz Eslie White, [01:44]

• "Kennedy came in and a new set of folks at the FDA and they said...We don't want just this data. We want a randomized controlled trial, which is a lot more expensive and time consuming."
  – Liz Eslie White, [06:43]

• "The FDA has failed the American people. You fail the American people every day. You allow this product to be pushed without knowing who actually benefits."
  – Dr. Vinay Prasad, [10:24]

• "He brought a level of credibility to this...but his criticisms aligned with Kennedy's criticisms of how the pandemic was handled."
  – Liz Eslie White, [10:53]

• "We are surprised and deeply disappointed."
  – Pierre Fabre spokesperson, [14:50]

• "They've had five leaders of their drug division over the last year, which is unprecedented turmoil."
  – Liz Eslie White, [17:01]

• "There is a mixture of opinion...a lot of the pharma industry...is far more worried about the drug pricing initiatives...than they're worried about what is going on at the FDA."
  – Liz Eslie White, [17:29]

Important Segments by Timestamp

• [00:23–01:26]: Flu season severity & introduction of FDA/Moderna story.
• [04:04–05:47]: Promise and mechanics of mRNA vaccines for flu.
• [06:32–07:10]: Shift to randomized-controlled trial expectations.
• [08:10–10:53]: Who is Dr. Prasad? His views and influence.
• [12:01–12:56]: Prasad’s rocky tenure, personnel dynamic, and costs.
• [13:40–14:50]: Real-world impact, Pierre Fabre case, inconsistencies.
• [15:20–15:44]: Internal FDA/White House debate; FDA reversal.
• [16:28–17:29]: Uncertainty in pharma sector & mixed reactions.

Tone and Style

The discussion is investigative yet accessible, blending hard news with behind-the-scenes color. Jessica Mendoza maintains a calm, explanatory manner; Liz Eslie White offers detailed, frank analysis. Direct quotes from Dr. Prasad and affected companies add dramatic and critical perspectives.

This episode offers a revealing look at how politics, personalities, and scientific standards collide inside one of America’s most powerful regulatory agencies, with direct consequences for millions of patients and the future of vaccine innovation.