Up First from NPR

The Munich Security Conference; FDA Rejects Flu Vaccine; The Fall of The Quad God

16 min
Feb 14, 20262 months ago
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Summary

This episode covers Secretary of State Marco Rubio's speech at the Munich Security Conference emphasizing U.S.-Europe unity and a new geopolitical era, the FDA's rejection of Moderna's mRNA flu vaccine citing insufficient study design, and Olympic figure skater Ilya Malinin's unexpected failure to medal despite being the heavy favorite.

Insights
  • The FDA's rejection of Moderna's flu vaccine application signals potential regulatory inconsistency under the new administration, creating uncertainty for biotech companies investing billions in clinical trials
  • mRNA vaccine development is shifting away from the U.S. to other countries due to regulatory risk and reduced government funding, potentially disadvantaging American biotech competitiveness
  • Secretary Rubio's Munich speech attempted to reassure European allies about U.S. commitment to transatlantic unity while addressing concerns about the 'old world order' ending
  • Regulatory risk—distinct from scientific or market risk—is becoming a significant factor deterring pharmaceutical companies from pursuing vaccine development in the U.S.
  • The Trump administration's skepticism toward mRNA vaccines, signaled through funding cuts and advisory board changes, is influencing corporate investment decisions in vaccine research
Trends
Regulatory inconsistency in FDA vaccine approval processes deterring biotech investment in the United StatesmRNA vaccine research migration from U.S. to international markets due to policy uncertaintyShift in U.S. foreign policy messaging toward European allies emphasizing renewal over traditional transatlantic frameworksReduced government funding for mRNA vaccine research under new administration prioritiesBiotech companies reassessing risk-benefit calculations for vaccine development amid changing regulatory environmentEuropean geopolitical realignment and increased emphasis on strategic autonomy from U.S. leadershipConcerns about regulatory predictability affecting long-term pharmaceutical R&D investment decisions
Companies
Moderna
FDA rejected its mRNA flu vaccine application aimed at adults 50+, citing insufficient study design despite prior app...
Pfizer-BioNTech
Referenced as co-developer of mRNA COVID-19 vaccine technology that Moderna sought to apply to flu vaccine development
People
Marco Rubio
U.S. Secretary of State who delivered keynote speech at Munich Security Conference on U.S.-Europe relations and new g...
J.D. Vance
Vice President whose previous Munich Security Conference speech focused on free speech and migration, contrasted with...
Ilya Malinin
U.S. Olympic figure skater who failed to medal despite being heavy favorite, falling twice and downgrading planned qu...
Robert F. Kennedy Jr.
Health Secretary who cut $500 million in mRNA vaccine research funding and fired vaccine advisory committee members
Friedrich Merz
Germany Chancellor who met with Secretary Rubio and discussed the end of the previous world order
Emmanuel Macron
French President who called for Europe to become a geopolitical leader and stand up to Russian aggression in Ukraine
Alexandria Ocasio-Cortez
New York Congresswoman who attended Munich Security Conference and criticized Trump administration for undermining de...
Helen Chu
Professor of medicine and epidemiology at University of Washington who explained mRNA vaccine technology and FDA reje...
Mikhail Shidurov
Kazakhstani figure skater who unexpectedly won gold medal in men's event after other top competitors fell
Quotes
"The old world is gone, frankly. the world I grew up in, and we live in a new era in geopolitics, and it's going to require all of us to sort of re-examine what that looks like and what our role is going to be."
Secretary of State Marco RubioMunich Security Conference speech
"So in a time of headlines heralding the end of the transatlantic era, let it be known and clear to all that this is neither our goal nor our wish. Because for us Americans, our home may be in the Western Hemisphere, but we will always be a child of Europe."
Secretary of State Marco RubioMunich Security Conference speech
"Companies simply cannot afford to conduct clinical trials, and then when they try to submit them to the regulator, have the regulator say, well, changed our mind. We're not going to accept your clinical trial."
Dr. Lindsay McNairFDA vaccine rejection discussion
"he said a lot of negative thoughts came flooding in as soon as he hit his starting pose."
Ilya MalininPost-competition interview
Full Transcript
And happy Valentine's Day, Scott. Happy Valentine's Day to you, Aisha. I was a very busy man getting everything ready for two daughters and my wife. I did it on Wednesday. So all the kids, so I got everybody flowers and told them they were loved. Because I want them to know they don't have to wait on some romantic love, right? Like that they can be celebrated. God bless you. Secretary of State Marco Rubio spoke at the Munich Security Conference today and outlined the U.S.-Europe relationship. We'll tell you how that speech was received. I'm Scott Simon. And I'm Aisha Roscoe. And this is Up First from NPR News. On his way to Munich, Secretary Rubio said the old world order is no more. The world is changing very fast right in front of us. The old world is gone, frankly. the world I grew up in, and we live in a new era in geopolitics, and it's going to require all of us to sort of re-examine what that looks like and what our role is going to be. But what does that mean for transatlantic unity? And the FDA has rejected a new flu shot. We'll look at how that could change clinical trials. Plus, the quad god has fallen. We'll have more on Ilya Malinan's heartbreak. So please stay with us. We've got the news you need to start your weekend. On NPR's Wildcard podcast, Oscar nominee Wagner Mora on keeping his values on his path to success. There were moments where I was like, oh, I really need that money. You know, but I'm like, I can't do this. I can't do that because otherwise I'll be miserable. Watch or listen to that Wildcard conversation on the NPR app or on YouTube at NPR Wildcard. I'm Jesse Thorne. On Bullseye, Yahya Abdul-Mateen II, and the most surprising thing he learned after receiving one of the highest honors in acting. I'm so grateful that it happened at that time because it did not make me happy at all. We'll get into that and his many roles playing various superheroes and villains. That's Bullseye. Find us in the NPR app at MaximumFun.org or wherever you get your podcasts. Secretary of State Marco Rubio told European allies at the Munich Security Conference today that it's time for a period of renewal as the old world order is ending. His speech at times highlighted unity, and it was different in tone from Vice President J.D. Vance's speech at the conference last year, which focused on free speech and migration. NPR's Michelle Kellerman was in Munich for the speech. Michelle, thanks for being with us. Nice to be here, Scott. What was Secretary Rubio's main message today? Well, he said that the U.S. and Europe made a lot of mistakes in recent years, focusing on what he called the climate cult and also allowing supply chains to become too dependent on rivals like China. He also spent a lot of time talking about Christian values and fears of civilizational erasure because of mass migration. Those were, you know, a big focus of Vance's speech last year. But Rubio couched it a bit differently. Take a listen. So in a time of headlines heralding the end of the transatlantic era, let it be known and clear to all that this is neither our goal nor our wish. Because for us Americans, our home may be in the Western Hemisphere, but we will always be a child of Europe. I hear applause there, Michelle. How did the speech go over? Yeah, I mean, the host of the conference, Wolfgang Ischinger, said there was a sigh of relief in the room. And he said he saw the speech as a message of reassurance. But, you know, I heard California Governor Gavin Newsom telling a group of reporters yesterday that Vice President Vance set the bar so low with last year's speech. And Germany Chancellor Friedrich Merz who met Rubio yesterday also talked about the world order as we know it is in the past But he told the U that the U isn strong enough to go it alone French President Emmanuel Macron who also here told the gathering that Europe needs to become a geopolitical leader and needs to really stand up to Russia's aggression in Ukraine. You mentioned Governor Newsom. There are other Democrats there as well, aren't there? Yeah. New York Congresswoman Alexandria Ocasio-Cortez made her debut here, And she's blaming the Trump administration of ripping up democratic norms and turning the world into what she calls an age of authoritarians who are carving up the world. Where Donald Trump can command the Western Hemisphere and Latin America as his personal sandbox, where Putin can saber rattle around Europe and for essentially authoritarians to have their own geographic domains. And she says she was here with other Democrats offering a different way forward. Russia's war in Ukraine is obviously a big concern for Europe. What did Secretary Rubio say about that? Yeah, I mean, Europeans are really alarmed by Russia's continued strikes on Ukraine's energy grid during this cold spell. They say Russia is trying to play for time, trying to win territory in talks with Trump's envoys that it hasn't been able to capture on the battlefield. Rubio would only say that he's not really sure if the Russians are serious about ending the war and whether there are any terms that can be negotiated that are acceptable to Ukraine. But he said the U.S. is going to continue to try. And that's been the goal. NPR's Michelle Kellerman from Munich. Thanks so much. Thank you. The Food and Drug Administration this week dealt a surprising setback to Moderna, one of the main biotech companies that created an mRNA vaccine against COVID-19. The agency rejected Moderna's new flu shot, which was aimed at adults age 50 and older. We're joined now by NPR's Sydney Lupkin, who has been following this story. Good morning, Sydney. Hi. Can you walk us through what happened with the Moderna shot? Yeah, so this was a first-of-its-kind flu shot that uses the mRNA technology just like the COVID shots from Moderna and Pfizer-BioNTech. Dr. Helen Chu, a professor of medicine and epidemiology at the University of Washington, says the mRNA technology is the reason those companies were able to respond to the COVID pandemic so quickly. And that's important because you need to scale up vaccine manufacturing at quite a clip to be able to make the number of doses that you need to be able to respond to a pandemic. So Moderna wants to use that technology again to tackle the flu. The traditional flu shot takes around six months to manufacture because it has to be grown in chicken eggs. So companies have to start making it really early, and by the time it's ready, the flu could have mutated. mRNA could make that process faster and more flexible. But on Tuesday, the FDA said it would not review Moderna's application, effectively rejecting it. It said the agency isn't satisfied with a Moderna study comparing its experimental mRNA flu vaccine to a standard dose flu vaccine already on the market. A high-potency vaccine is recommended for people 65 and older, and that's what a statement from the Department of Health and Human Services said the FDA was looking for in that age group. HHS said the FDA had communicated that preference before. So how unusual is this for the FDA to decide not to even review a new vaccine? So Chu told me it's unusual to hear from the FDA that a study isn't acceptable so late in the process because companies are talking with the agency before a study even begins to make sure it's okay. But she also told me she was surprised Moderna filed the application. That's because the Trump administration had already been signaling that it wasn't friendly toward mRNA vaccines. Health Secretary Robert F. Kennedy Jr. announced in August that he was cutting a half billion dollars in funding for mRNA vaccine research. He also fired 17 members of an influential vaccine advisory committee That included Chu And then the new hand committee recommended making the COVID shots less routine I should add that the government also reduced the number of vaccines recommended for children beyond just COVID What does Moderna say about what happened? It says the rejection doesn't line up with what the FDA was saying before, and that the agency okayed this trial design 18 months ago. And by the way, Moderna says it cost a lot of money to do this research, more than a billion dollars all told. Companies making that kind of investment are looking for regulatory consistency. Dr. Lindsay McNair is a consultant at Equipoise and advises companies on clinical trials. She says this isn't the first time in recent months the FDA has done this, and the biotech community is concerned. Companies simply cannot afford to conduct clinical trials, and then when they try to submit them to the regulator, have the regulator say, well, changed our mind. We're not going to accept your clinical trial. So what does this mean for the big picture in terms of flu vaccines, but also companies developing other kinds of vaccines? Yeah, so I'm told that when it comes to mRNA vaccines, that work is moving forward, but in other countries. So it's really the United States that could be at a disadvantage here. There's a lot of risk involved in developing a new vaccine, Risk the company will do the study and it won't work, or there won't be a market for it, and risk that the regulatory agency won't approve it. Those first two are kind of built into the calculus of being a pharmaceutical company, but regulatory risk isn't as much. Historically, in the U.S., the FDA has been pretty consistent. The FDA saying no to a study design it had previously agreed to is risk that's harder to navigate, and it could lead companies to think twice. That was NPR Pharmaceuticals Correspondent, Sydney Lepkin. Thank you, Sydney. You bet. Well, Aisha, looks like even gods can fall. That's right, Scott. And anyone watching U.S. Olympic figure skater Ilya Malinan compete in the men's gold event yesterday saw that happen in real time. More than once. He was widely expected to win gold in the event. Turned out it didn't even medal. So what went wrong? NPR's Rachel Triesman was watching. From the Milano Ice Skating Arena. Rachel, thanks for being with us. Thanks for having me. He is a global phenomenon, just 21. Hadn't lost a major competition since 2023. What was the mood like when he took the ice? I'll try to paint a picture. So Malin was the very last skater of the entire night, and there was just this sense in the room that he would be the grand finale. He got the loudest applause of anyone just by skating out to do his warm-ups. All eyes were on him. The stands were super packed. There were Olympic greats in the room like Nathan Chen and Simone Biles. And the question people around me were asking wasn't whether Malin would win, but how would he do it? How many quad jumps would he do? And of course, would he attempt and land the quad axle, which would be the first on Olympic ice? When did it all start going wrong? Pretty much immediately. Malanin's second planned jump out of seven was the quad axle, but he downgraded it midair to just a single axle. And it got harder to watch from there. He bailed on a couple other jumps and fully fell twice. One of the jumps he did manage to land was a backflip. But of course, that doesn't get you any points. Just a lot of love from the crowd. And what was the reaction of the crowd? Well, the crowd started off so energized for his performance, and once he got started, it just totally felt like the wind had been knocked out of everyone. Some people around me had their phones out to film what was supposed to be this historic jump and then pretty quickly put their phones away. I feel like it took a moment for people to realize what they were seeing, and then when they did, the crowd suddenly got loud again, as if people in the stands were trying to boost Malin and up with their own energy their own nervous energy in particular But it didn work And at the end of the four minutes Malanin just looked anguished as he walked off the ice And what did this extraordinary young man say about what went wrong Well, a lot of us asked him. So athletes typically talk to the press right after they skate. And just a few minutes later, I was standing in this crush of journalists, all eager to hear from him. And Malinan clearly hadn't had a second to process what had just happened. He was clearly still trying to understand. But he did blame the pressure he'd been under as the heavy favorite. and he said a lot of negative thoughts came flooding in as soon as he hit his starting pose. We should ask who won. So two Japanese skaters ended up on the podium. Yuma Kagiyama repeated his silver from 2022, and Shun Sato won bronze. But the real shocker was the first place finisher, Mikhail Shidurov of Kazakhstan. He wasn't expected to medal at all, though he was clearly a fan favorite. He landed a really clean skate with five quad jumps that put him in first place. There were still a handful of top-ranked skaters to follow him, including Malinin. So I don't think Shidorov was expecting to stay on the top of the scoreboard, but all of the skaters after him fell. So we could see him watching in real time as he processed that he had won bronze, then silver, and then somehow gold. And after Malinin got his score, he walked over to hug Shidorov, who was just standing there in total shock with his hands on his face. Medals for women's figure skating and pairs figure skating are still ahead. more competitions this week, but this was Ilya Malin's last chance at a medal this year, wasn't it? That's right. And it's important to note he will still leave these Olympics with a gold medal from last weekend's team event, which, I mean, ironically, his free skate helped the U.S. win. But yeah, yesterday was his last chance at an individual medal. We may see him skate again at an exhibition event next weekend, but we'll have to see him in a future Olympic cycle if he wants to earn his individual medal. NPR's Rachel Treisman in Milan. Rachel, thanks so much for being with us. Of course. Thank you. And Rachel is writing a daily newsletter about what it's like to be at the games in person. It's called Rachel Goes to the Games. You can subscribe to it at npr.org slash wintergames. And you can check out Up First Winter Games, a new video podcast from the team that brings you Up First. Find it every afternoon at youtube.com slash npr. And that's up first for Saturday, February 14, 2026. I'm Scott Simon. And I'm Aisha Roscoe. Elena Twarick produced today's podcast with help from Dave Mistich and Jordan Marie Smith. Our editor is Dee Parvaz. She had help from Nick Spicer, Miguel Macias, Eric Whitney, Martin Patience, Jacob Finston, and Diana Douglas. Michael Radcliffe is our director. Our technical director is David Greenberg with engineering support from Simon Laszlo Jansen and Zoe Vangenhoven. Our senior supervising editor is Shannon Rhodes. Evie Stone is our executive producer and Jim Kane is our deputy managing editor. Tomorrow on the Sunday story, in 2024, a woman took the stand in an unprecedented mass rape trial in France. Among the over 50 perpetrators was her husband. Now Giselle Pellico has written a memoir of survival titled A Hymn to Life. Shame has to change sides. Our colleague Michelle Martin interviewed Giselle Pelico about the shocking case, her decision to hold an open trial, and so much more. And of course, we have all the latest news, music, movies, sports, and so much more. You can just tune into NPR and find your local station at stations.npr.org. Thank you for listening. Thank you.