The Flu Shot Drama at the FDA

Summary

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

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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.

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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]

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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]

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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.

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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.

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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.

Transcript

[A]

Liz, we're both here in D.C. and I don't know about you, but I feel like flu season has been kind of nuts this year. I just got over being sick. Have you or your kids or anybody in your household gotten the flu this year?

[B]

We have avoided it this year.

[A]

That's our colleague Liz Eslie White. She covers health policy for the Wall Street Journal. And while she managed to avoid the flu this year, a lot of people in the country haven't been as lucky. U.S. officials estimate there have been at least 23 million cases and 19,000 deaths since October, making this one of the worst flu seasons in recent years. I asked you about flu season because lately you've been following a story about the FDA and a new flu shot. Can you tell us what's been going on?

[B]

Yeah. So the FDA has gone through a lot of change in the past year, and it still really surprised people when last week, Moderna, which is a company that makes vaccines, said that the FDA had refused to even look at its application for a new flu shot. And today we heard from Moderna that the FDA had in fact agreed to finally review its application.

[A]

Okay, so Moderna submitted an application for a new flu shot. The FDA refused to review it, but now it is going to review it. What does this back and forth tell you about how the FDA is thinking about new drugs and approving new drugs in this moment?

[B]

Well, the first kind of initial refusal to even look at the shot was pretty surprising because as Moderna said when it came out and really criticized this decision, the FDA had already signed off on the way that Moderna was looking at studying the flu shot. So Moderna really felt like the FDA was kind of changing the rules of the game during the game. And this was one of just kind of many regulatory U turns the agency had taken recently.

[A]

Welcome to the Journal. Our show about about money, business and power. I'm Jessica Mendoza. It's Wednesday, February 18th. Coming up on the show, the FDA's back and forth on a new flu shot.

[C]

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[A]

Moderna exploded onto the pharmaceutical scene during the pandemic with its MRNA COVID vaccine.

[B]

And then it got tapped to be one of the operation warp speed leaders. And it gave us one of the first Covid shots that allowed us to emerge from the pandemic. What's interesting about Moderna is it never really diversified beyond that technology, that messenger RNA technology.

[A]

And as a quick reminder, MRNA vaccines are different from traditional vaccines. Traditional vaccines use a dead or weakened form of a virus or bacteria to develop an immune response. MRNA vaccines teach your body to create a protein that supports the immune system's defenses when you're exposed to a virus. This allows vaccine makers to more easily combat different variants of a virus. That flexibility is especially important when it comes to something like the flu because the flu shifts and mutates every year. And the way we currently make flu vaccines is a bit of a global.

[B]

Guessing game right now. How we do flu vaccines is we look at what's going on the other side of the globe. So Australia is having summer while we have winter, and then when we have summer, they'll have winter. And you look at what the flu is doing down there and you say, okay, we think maybe this strain is gonna dominate in six months, and we're gonna pick a vaccine that can match that one as the one that we recommend to people for the flu. And that process takes time. It's pretty tedious. The promise of MRNA technology is that you can do that with a little bit quicker turnaround. And so you would be able, especially in a flu pandemic scenario, to get a vaccine out much more quickly if you had a good flu MRNA vaccine.

[A]

Moderna decided it wanted to develop that vaccine. Until recently, developing a shot like that involved giving groups of people the vaccine and checking afterward to see if it caused an immune response.

[B]

In the past, the FDA had said, okay, we know generally that flu vaccines and these types of vaccines are generally safe. We have kind of a buildup of scientific data on this. And so when you're, when you're tweaking your COVID vaccine or your flu Vaccine. It's okay to do a study where you just see if someone's antibodies increase versus doing a study that shows, you know, they didn't get flu, which is more.

[A]

It's like a higher threshold.

[B]

Yes, it's a more involved study.

[A]

But President Trump's health secretary, Robert F. Kennedy Jr. Has said that the traditional process doesn't meet what the administration calls gold standard science.

[B]

Kennedy came in and a new set of folks at the FDA and they said, this is no longer good enough. We don't want just this data. We want a randomized controlled trial, which is a lot more expensive and time consuming.

[A]

And then Moderna comes out and says, okay, we've done these clinical trials and the agency refused to even review what they'd already done. What did the agency say about that? Why did the FDA refuse to review the application to move forward?

[B]

Yeah, so they issued a letter to Moderna and said, we're not even going to look at your flu shot. And what they said is because you didn't have an adequate clinical trial and that you didn't use the right vaccine to compare it against, which is just very unusual. You don't normally reject, you know, even looking an application for that kind of substantive disagreement scientifically with how they went about studying this flu shot. Normally when FDA does these rejections, it's because they're like missing a big chemistry section or, hey, you need to like go back and add these technical things that are just like, not in this application. Can you add that and then try again? So this was very different from the norm and from our reporting. There's a specific regulator there who was hired by the Trump administration and he had an issue with Moderna not doing that higher dose flu vaccine comparator.

[A]

That regulator is Dr. Vinay Prasad, the head of vaccines at the FDA. He wanted Moderna to test its MRNA flu shot against a higher dose flu vaccine to see if it was better.

[B]

And Moderna only did that for a subset of their people and not everybody. And so he took an issue with that and decided that was a good enough reason to just not even look at the application.

[A]

Prasad's decision to block Moderna's MRNA flu vaccine instead of sending its application back for the company to test it again was unpopular in the fda. According to Liz's reporting, staff members held an hour long meeting with him to discuss their objections to his decision. During the throes of the COVID pandemic MRNA vaccines were widely used, but also controversial among the anti vaccine crowd. How much of that sentiment is at play here.

[B]

So Kennedy himself is a huge critic of MRNA vaccines.

[D]

HHS has determined that MRNA technology poses more risk and benefits for these respiratory viruses.

[B]

And he has said that MRNA vaccines to respiratory illnesses never work. And he's installed people who share his skepticism of that, you know, both at the CDC and the fda.

[A]

One of those people was Prasad. He's a doctor, more specifically a hematologist, oncologist. And during the pandemic, he was critical of the COVID vaccine, especially for children.

[B]

He kind of became famous online during the pandemic as, you know, well, credentialed doctor who would criticize Dr. Fauci, criticize a lot of the health measures that were being taken in the pandemic, and criticize the way FDA had ushered through the Moderna and Pfizer vaccines.

[A]

Here's Prasad in a video posted to his YouTube channel.

[D]

Segregating people based on vaccine status in that age group 5 to 11 would be unjust. Having different quarantine rules for 5 to 11 year olds. This is a point that will reject.

[B]

Before he joined FDA, Dr. Prasad was known as someone who had a pretty sharp critique of the agency. He said it approved a lot of useless drugs.

[D]

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.

[B]

He became kind of this Covid firebrand who was always on substack or X and saying, you know, we had gone about the pandemic totally incorrectly.

[D]

The only way for public health had credibility is to be almost 100% correct in their proclamations and to use mandates only when they really know for sure. And I think they've abused that power.

[B]

And he brought a level of credibility to this as someone who had done a lot of writing about drugs and thinking about drugs as an academic. And, you know, he really irritated everyone at the FDA even prior to coming there because of these, like, sharp criticisms. But he is someone who, you know, those criticisms aligned with Kennedy's criticisms of how the pandemic was handled.

[A]

Those criticisms have come to define this era at the fda. Beyond Moderna's MRNA flu shot, Prasad has moved to block other drugs as well. That's next. Vinay Prasad's tenure at the FDA has been rocky.

[B]

He ran afoul of some people very close to the Trump administration, notably Laura Loomer, who's a right wing provocateur, and she took him to task for his past support of Bernie Sanders and liberal causes.

[A]

The whole dust up led to Prasad being pushed out of the FDA Last July. But two weeks later, he was rehired.

[B]

So he's already been through a lot at the fda, and since then, he has just continued to cause controversy at the agency. I've talked to a lot of FDA employees who have found him to be very hard to work with. He has a number of personnel complaints against him, including some for retaliation.

[A]

The other thing about Prasad is that he lives in San Francisco, not in Maryland, where the FDA is based. And he's only there several days out of every two weeks. According to an agency document that Liz reviewed, his commute costs American taxpayers $65,000 a year. And so let's go back to him refusing to review Moderna's flu shot the first time around. Is that in line with his approach to running the fda?

[B]

It is in line with his approach. It's not in line with the past approaches of the fda. And it's one of the reasons that people are worried about him and his tenure there. One thing that's been going on is Dr. Prasad and FDA Commissioner Marty Makary talk a lot about how they want to help rare disease drugs, which are these. It's really hard to study rare disease and hard to get drugs for these small populations of patients. But then at the same time, they're issuing all these decisions out of Vinay Prasad's shop. That really discouraged the rare disease community. And, you know, we found nine companies that have publicly complained that the FDA did a big U turn on them.

[A]

One of those companies was Pierre Fabre Pharmaceuticals, which was testing a treatment for a rare but life threatening disease that can follow an organ transplant.

[B]

They had a therapy and it got rejected the first time for a manufacturing issue. There was an inspection issue with how they were making it. And so they said, okay, we'll fix that. They fixed it. They had all these meetings with the fda, and FDA said, you know, great, this is looking good. There were no other concerns raised. So within those meetings, that's where you would expect to hear, you know, other concerns or even in the first rejection over months and months. And then out of the blue, they got rejected in January for the way that their clinical trial had been set up.

[A]

For that trial, Pierre Fabre used what's known as a single arm trial, which is an experiment where all subjects get the treatment. No one gets a placebo.

[B]

What's weird is they get this rejection. And a couple days later, Dr. Prasad is at a healthcare conference and saying, oh, actually, I think, you know, single arm trials for rare diseases are great. So he got taken to task for this by analysts, including one who said, you know, the rhetoric is not matching the actions.

[A]

A spokesperson for Pierre Fabre said of the decision, quote, we are surprised and deeply disappointed. A Health and Human Services spokesman said that the agency is committed to advancing safe and effective treatments for patients with rare diseases. He added, quote, our decisions are guided by rigorous science and the best available evidence. But for Moderna, the FDA reversed course on its decision. Right. What do we know about why the agency changed its mind about reviewing the flu shot application?

[B]

Well, we reported today that this change of heart came from the FDA after discussions that were had between FDA officials and White House and Department of Health and Human Services officials.

[A]

A White House spokesman said the FDA's decision was not choreographed by the White House. So what happens now for Moderna? What's next for the new flu shot?

[B]

Yeah, actually, the new flu shot, you know, it could be available for this upcoming 2026-2027 flu season, which is great news for Moderna, possibly good news for people who want a, you know, new and improved flu shot. And we'll have to see if the agency approves it. Marty McCary, the FDA commissioner, yesterday at an event hinted that the agency could still approve it, and then they will have till later this summer to make that decision and really look at the application. And so August 5th is the decision day for this flu vaccine.

[A]

What does this moment tell you about what the process could look like for new drugs going forward under this fda?

[B]

I think there's a lot of uncertainty in the sector right now from just talking to people, certainly for rare disease and certainly for vaccines. Those two areas are probably the highest level of anxiety. And then there are also other people who are just worried generally about the fda, because in addition to kind of this willingness to do regulatory reversals, they've lost a lot of people. They've lost reviewers. They've lost scientific expertise. They've had a huge turnover in their leadership ranks. I mean, they've had five leaders of their drug division over the last year, which is unprecedented turmoil. And that's notable for pharmaceutical companies because they really rely on a predictable, steady, kind of easy to understand fda as they're investing millions in clinical trials and drug development. They don't want to have the rug pulled out from under them.

[A]

An FDA spokesperson called the agency's reforms successful and broadly popular.

[B]

There are people who don't think we need to be so worried about fda. They think it's okay, and they like a lot of the new proposals that have come out of the Trump administration. They think it's headed in a good direction. And a lot of the pharma industry, honestly, in some ways is far more worried about the drug pricing initiatives that the Trump administration is trying to do than they're worried about what is going on at the fda. So there is a mixture of opinion there.

[A]

That's all for today. Wednesday, February 18th. The Journal is a co production of Spotify and the Wall Street Journal. Additional reporting in this episode by Peter Loft. Thanks for listening. See you tomorrow.