What are the key takeaways from this The Journal episode?

Key insights include: **mRNA Flu Vaccine Timeline:** Moderna's mRNA flu shot could reach consumers for the 2026–2027 flu season, with the FDA's decision deadline set for August 5. The technology promises faster vaccine production than the current six-month global strain-guessing process used annually.; **Regulatory Goalpost Shifting:** The FDA, under Dr. Vinay Prasad, now requires randomized controlled trials instead of antibody-response studies for vaccine approval — a costlier, more time-consuming standard that contradicts prior agreements made with Moderna before clinical trials began.; **Rare Disease Drug Risk:** Nine companies have publicly reported sudden FDA U-turns on previously approved trial designs. Pierre Fabre Pharmaceuticals received a rejection citing trial methodology concerns — the same single-arm trial approach Prasad publicly praised at a conference just days later.

What did Liz Esley White discuss on The Journal?

The FDA's reversal on reviewing Moderna's mRNA flu shot application reveals deep regulatory instability under Dr. Vinay Prasad, with at least nine pharmaceutical companies reporting sudden policy U-turns affecting drug approvals across vaccines and rare diseases. Key topics include: **mRNA Flu Vaccine Timeline:** Moderna's mRNA flu shot could reach consumers for the 2026–2027 flu season, with the FDA's decision deadline set for August 5. The technology promises faster vaccine production than the current six-month global strain-guessing process used annually.; **Regulatory Goalpost Shifting:** The FDA, under Dr. Vinay Prasad, now requires randomized controlled trials instead of antibody-response studies for vaccine approval — a costlier, more time-consuming standard that contradicts prior agreements made with Moderna before clinical trials began..

How long is this episode of The Journal?

This episode is 19 minutes long. SignalCast provides an AI-generated summary so you can get the key insights in about 3 minutes.

The Journal

The Flu Shot Drama at the FDA

February 18, 2026

19 min episode · 2 min read

Liz Esley White

Episode

19 min

Read time

2 min

Topics

Investing, Fundraising & VC, Design & UX

AI-Generated Summary

Published Feb 20, 2026

Key Takeaways

✓mRNA Flu Vaccine Timeline: Moderna's mRNA flu shot could reach consumers for the 2026–2027 flu season, with the FDA's decision deadline set for August 5. The technology promises faster vaccine production than the current six-month global strain-guessing process used annually.
✓Regulatory Goalpost Shifting: The FDA, under Dr. Vinay Prasad, now requires randomized controlled trials instead of antibody-response studies for vaccine approval — a costlier, more time-consuming standard that contradicts prior agreements made with Moderna before clinical trials began.
✓Rare Disease Drug Risk: Nine companies have publicly reported sudden FDA U-turns on previously approved trial designs. Pierre Fabre Pharmaceuticals received a rejection citing trial methodology concerns — the same single-arm trial approach Prasad publicly praised at a conference just days later.
✓FDA Institutional Instability: The FDA's drug division has cycled through five leaders in one year, losing significant scientific staff through turnover. Pharmaceutical companies investing millions in clinical trials depend on regulatory predictability; current volatility raises financial risk across the entire drug development pipeline.

What It Covers

The FDA's reversal on reviewing Moderna's mRNA flu shot application reveals deep regulatory instability under Dr. Vinay Prasad, with at least nine pharmaceutical companies reporting sudden policy U-turns affecting drug approvals across vaccines and rare diseases.

Key Questions Answered

•mRNA Flu Vaccine Timeline: Moderna's mRNA flu shot could reach consumers for the 2026–2027 flu season, with the FDA's decision deadline set for August 5. The technology promises faster vaccine production than the current six-month global strain-guessing process used annually.
•Regulatory Goalpost Shifting: The FDA, under Dr. Vinay Prasad, now requires randomized controlled trials instead of antibody-response studies for vaccine approval — a costlier, more time-consuming standard that contradicts prior agreements made with Moderna before clinical trials began.
•Rare Disease Drug Risk: Nine companies have publicly reported sudden FDA U-turns on previously approved trial designs. Pierre Fabre Pharmaceuticals received a rejection citing trial methodology concerns — the same single-arm trial approach Prasad publicly praised at a conference just days later.
•FDA Institutional Instability: The FDA's drug division has cycled through five leaders in one year, losing significant scientific staff through turnover. Pharmaceutical companies investing millions in clinical trials depend on regulatory predictability; current volatility raises financial risk across the entire drug development pipeline.

Notable Moment

Despite publicly championing single-arm clinical trials as valid for rare diseases at a healthcare conference, Prasad's office had rejected Pierre Fabre's drug application using that exact trial design just days earlier — a contradiction flagged by industry analysts.

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Episode Transcript

Liz, we're both here in DC. 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? We have avoided it this year. That's our colleague, Liz Esley 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. US officials estimate there have been at least twenty three million cases and nineteen thousand 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? 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. 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? 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, you know, really criticized this decision, the FDA had already signed off on the way that Moderna was, you know, 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. Coming up on the show, the FDA's back and forth on a new flu shot. This episode is brought to you by Indeed. Hiring isn't just about finding someone willing to take the job. It's about finding someone with the right skills and background who can move your business forward. And a good way to start your search is with Indeed sponsored jobs. It's one of the best ways to make your job post stand out and reach the candidates you're looking for faster. According to Indeed data, sponsored jobs posted directly on Indeed are 90% more likely to report a hire than non sponsored jobs. Plus, there's no monthly subscriptions or long term contracts. You're only paying for results. Find the candidates who check all your boxes faster with Indeed sponsored jobs. Listeners of this show will get a $75 sponsored job credit to help get your job the premium …

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