In short
Podcast Episode Notes: The Flu Shot Drama at the FDA
Episode Overview
- Podcast Title: The Journal
- Episode Title: The Flu Shot Drama at the FDA
- Hosts: Ryan Knutson and Jessica Mendoza
- Guest: Liz Essley Whyte, WSJ Health Policy Reporter
- Date: February 18, 2024
- Description: The episode discusses the FDA's recent agreement to review Moderna's application for a new seasonal flu shot, following an initial refusal. The conversation explores the implications of this decision and the turmoil within the FDA.
Key Discussion Points
Current Flu Season Context
- Flu Statistics: The flu season has been severe, with at least 23 million cases and 19,000 deaths reported since October.
- Personal Impact: Hosts discuss personal experiences with flu, highlighting the seriousness of the current season.
FDA's Review of Moderna's Flu Shot
- Initial Refusal: The FDA initially refused to review Moderna's application for a new flu shot, which surprised many, including Moderna.
- Reversal Decision: The FDA later agreed to review the application, indicating a back-and-forth dynamic that raises questions about the agency's regulatory processes.
Regulatory Turmoil
- Change in FDA Leadership: Discussion about the FDA's recent changes and how they affect decision-making, including an emphasis on stricter requirements for vaccine trials.
- Vinay Prasad's Role:
- Prasad, the head of vaccines at the FDA, is noted for blocking Moderna's application due to concerns regarding the clinical trial's design.
- His approach represents a significant shift in regulatory standards and has led to staff dissatisfaction within the FDA.
mRNA Vaccine Technology
- Difference from Traditional Vaccines:
- Traditional vaccines use dead or weakened viruses; mRNA vaccines instruct the body to produce proteins to combat viruses.
- The potential for quicker adaptation to flu variants with mRNA technology is emphasized.
Political and Public Sentiment
- Criticism of mRNA Technology:
- Dr. Prasad's past criticisms of mRNA vaccines and alignment with anti-vaccine sentiments are discussed.
- Concerns about public trust in vaccines are highlighted, particularly given the controversial reception of COVID-19 mRNA vaccines.
Future Directions for the FDA
- Implications for Drug Approval:
- The discussion points to uncertainty regarding the FDA's future direction, especially concerning rare disease drug approvals and vaccine development.
- The FDA's recent leadership instability is noted, with five leaders in the drug division over the past year.
Key Takeaways
- Uncertainty in Regulatory Environment: The FDA's shifting stance on vaccine approvals creates anxiety among pharmaceutical companies and stakeholders regarding drug development.
- Impact of Leadership Changes: The ongoing turmoil within the FDA, including the controversial presence of figures like Dr. Prasad, has led to concerns about the agency's consistency and reliability.
- Potential for Future Vaccines: If approved, Moderna's flu shot could be available for the 2026-2027 flu season, indicating a significant shift in how flu vaccines may be developed and deployed.
Further Listening Recommendations
- Related Episodes:
- The FDA Commissioner on Vaccines and Public Trust
- Breakfast Battle: The Cereal Industry vs MAHA
Conclusion The episode reveals critical insights into the FDA's evolving approach to drug and vaccine approvals amidst a challenging public health landscape, emphasizing the complex interplay between science, policy, and public perception.
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Written by AI. May contain mistakes. Listen to the episode to check what was said.
Chapters
Tap a time to open that second in VOFDA's Response to Moderna's Flu Shot Application
0:46 to 2:00
Discussion on the FDA's initial refusal to review Moderna's flu shot application.
“And today, we heard from Moderna that the FDA had, in fact, agreed to finally review its application.”
Understanding mRNA Vaccines
2:01 to 4:20
Exploration of mRNA vaccine technology and its implications for flu vaccines.
“So Moderna really felt like the FDA was kind of changing the rules of the game during the game.”
Regulatory Changes at the FDA
4:21 to 6:20
Examination of recent regulatory changes at the FDA impacting vaccine approvals.
“Traditional vaccines use a dead or weakened form of a virus or bacteria to develop an immune response.”
Criticism of FDA Leadership
6:21 to 8:30
Analysis of criticism towards FDA officials regarding their decisions on vaccines.
“But President Trump's health secretary, Robert F.”
Impact of Political Sentiments on Vaccine Approval
8:31 to 10:30
Discussion on how political sentiments influence vaccine approval processes at the FDA.
“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.”
Ongoing Controversy at the FDA
13:06 to 14:03
Discussion on ongoing controversies and personnel issues at the FDA.
“Vinay Prasad's tenure at the FDA has been rocky.”
Concerns About FDA Leadership and Rare Diseases
14:03 to 16:42
Explore the challenges and criticisms surrounding the FDA's handling of rare disease drug approvals.
“According to an agency document that Liz reviewed, his commute costs American taxpayers$65 ,000 a year.”
Moderna's Flu Shot Review Process
16:42 to 17:55
Learn about the FDA's shifting stance on Moderna's flu shot and the implications for vaccine approval.
“What do we know about why the agency changed its mind about reviewing the flu shot application?”
Uncertainty in the Pharmaceutical Sector
17:55 to 18:34
Understand the anxiety in the pharmaceutical industry regarding FDA stability and regulatory processes.
“Those two areas are probably the highest level of anxiety.”
Mixed Opinions on FDA Reforms
18:34 to 19:17
Discover the varying perspectives on recent FDA reforms and their impact on drug pricing.
“As they're investing, you know, millions in clinical trials and drug development, they don't want to have the rug pulled out from under them.”
Transcript
Automatic transcript. May contain errors.0:05Liz Essley Whyte: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. 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 Essley Whyte. 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.
0:44Liz Essley Whyte: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?
0:51Jessica Mendoza: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.
1:25Liz Essley Whyte: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 really criticized this decision, the FDA had already signed
1:59Jessica Mendoza: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.
2:21Liz Essley Whyte:Welcome to The Journal, our show about money, business, and power. I'm Jessica Mendoza. It's Wednesday, February 18th.
2:34Liz Essley Whyte:coming up on the show the fda is back and forth on a new flu shot
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3:54Liz Essley Whyte:Moderna exploded onto the pharmaceutical scene during the pandemic with its mRNA COVID vaccine.
4:00Jessica Mendoza: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.
4:20Liz Essley Whyte: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 guessing game.
4:55Jessica Mendoza: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 going to dominate in six months, and we're going to 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 the flu pandemic scenario, to get a vaccine out much more quickly if you had a good flu mRNA vaccine.
5:44Liz Essley Whyte: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.
5:56Jessica Mendoza: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 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... It's like a higher threshold. Yes, it's a more involved study.
6:29Liz Essley Whyte: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.
6:40Jessica Mendoza: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.
6:53Liz Essley Whyte:And then Moderna comes out and says, OK, 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?
7:07Jessica Mendoza: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.
7:46Jessica Mendoza: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.
8:07Liz Essley Whyte: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.
8:19Jessica Mendoza: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.
8:34Liz Essley Whyte: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?
9:04Jessica Mendoza:So Kennedy himself is a huge critic of mRNA vaccines.
9:09Liz Essley Whyte:HHS has determined that mRNA technology poses more risks and benefits for these respiratory viruses.
9:18Jessica Mendoza: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. One of those people was Prasad.
9:33Liz Essley Whyte:He's a doctor, more specifically a hematologist oncologist. And during the pandemic, he was critical of the COVID vaccine, especially for children.
9:42Jessica Mendoza:He kind of became famous online during the pandemic as, you know, a 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.
9:59Liz Essley Whyte:Here's Prasad in a video posted to his YouTube channel. 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 we'll be just...
10:12Jessica Mendoza: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.
10:21Liz Essley Whyte: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.
10:29Jessica Mendoza:He became kind of this COVID firebrand who was always on Substack or Axe and saying, you know, we had gone about the pandemic totally incorrectly.
10:40Liz Essley Whyte:The only way for public health had credibility is to be almost 100 percent correct in their proclamations and to use mandates only when they really know for sure. And I think they've abused that power.
10:51Jessica Mendoza: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.
11:15Liz Essley Whyte: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.
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13:08Liz Essley Whyte:Vinay Prasad's tenure at the FDA has been rocky.
Read the full transcript
13:15Jessica Mendoza: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.
13:28Liz Essley Whyte:The whole dust-up led to Prasad being pushed out of the FDA last July. But two weeks later, he was rehired.
13:35Jessica Mendoza: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.
13:56Liz Essley Whyte: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?
14:22Jessica Mendoza: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. Persaud and FDA Commissioner Marty McHary 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.
15:07Liz Essley Whyte:One of those companies was Pierre Fabra Pharmaceuticals, which was testing a treatment for a rare but life-threatening disease that can follow an organ transplant.
15:18Jessica Mendoza: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.
15:50Liz Essley Whyte: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.
15:59Jessica Mendoza:What's weird is they get this rejection, and a couple days later, Dr. Prasad is at a health care 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.
16:17Liz Essley Whyte:A spokesperson for Pierre Fabra 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?
16:47Jessica Mendoza: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.
17:00Liz Essley Whyte: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?
17:11Jessica Mendoza:Yeah, actually, the new flu shot, you know, it could be available for this upcoming 2026 to 2027 flu season, which is great news for Moderna, possibly good news for people who want a new and improved flu shot. And we'll have to see if the agency approves it. Marty McHary, 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.
17:49Liz Essley Whyte:What does this moment tell you about what the process could look like for new drugs going forward under this FDA?
17:54Jessica Mendoza: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 in turmoil.
18:33Jessica Mendoza: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, you know, millions in clinical trials and drug development, they don't want to have the rug pulled out from under them.
18:51Liz Essley Whyte:An FDA spokesperson called the agency's reforms successful and broadly popular.
18:56Jessica Mendoza:There are people who don't think we need to be so worried about the FDA. They think it's OK. 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. Then they're worried about what is going on at the FDA. So there is a mixture of opinion there.
19:34Liz Essley Whyte: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 Loftus.
19:49Liz Essley Whyte:Thanks for listening. See you tomorrow.
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From the publisher
The Food and Drug Administration agreed to begin a review of biotech company Moderna’s application to make a new seasonal flu shot available. The decision comes after the FDA initially refused to review the company's application. It's a back and forth that reveals increased turmoil within the agency. WSJ’s Liz Essley Whyte takes us inside the FDA’s unexpected reversals and explores what’s next for the mRNA flu vaccine. Jessica Mendoza hosts.
Further Listening:
- The FDA Commissioner on Vaccines and Public Trust
- Breakfast Battle: The Cereal Industry vs MAHA
Sign up for WSJ’s free What’s News newsletter.
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