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Moderna says FDA refuses its application for new mRNA flu vaccine

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Moderna says FDA refuses its application for new mRNA flu vaccine

WASHINGTON (AP) — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.

The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation’s top health official.

Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. That trial concluded the new vaccine was somewhat more effective in adults 50 and older than that standard shot.

The letter from FDA vaccine director Dr. Vinay Prasad said the agency doesn’t consider the application to contain an “adequate and well-controlled trial” because it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.” Prasad’s letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn’t follow.

According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company had chosen — but that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study. Still, Moderna said, the FDA did agree to let the study proceed as originally planned.

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The company said it also had shared with FDA additional data from a separate trial comparing the new vaccine against a licensed high-dose shot used for seniors.

The FDA “did not identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stephane Bancel said in a statement.

It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions.

Moderna has requested an urgent meeting with FDA, and noted that it has applied for the vaccine’s approval in Europe, Canada and Australia.

In the last year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccines — which are made with mRNA technology — and removed critics of the administration’s approach from an FDA advisory panel.

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Kennedy announced last year that his department would cancel more than $500 million in contracts and funding for the development of vaccines using mRNA.

FDA for decades has allowed vaccine makers to quickly update their annual flu shots to target the latest strains by showing that they trigger an immune response in patients. That’s a far more efficient approach than running long-term studies tracking whether patients get the flu and how they fare. In an internal memo last year, Prasad wrote that the streamlined method would no longer be permitted – leading more than a dozen former FDA commissioners to pen an editorial condemning the statements.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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Where King Charles' brother Andrew shows up in the Epstein files

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Where King Charles' brother Andrew shows up in the Epstein files
King Charles’ younger brother Andrew Mountbatten-Windsor was arrested on Thursday on suspicion of misconduct in public office over allegations that he sent confidential government documents to the late sex offender Jeffrey Epstein. He was released later in the day and has not been charged with a crime.
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Iran rebuilding nuclear program despite Trump talks, opposition figure claims

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Iran rebuilding nuclear program despite Trump talks, opposition figure claims

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Iran is rebuilding nuclear sites damaged in previous U.S. strikes and “preparing for war,” despite engaging in talks with the Trump administration, according to a prominent Iranian opposition figure.

Alireza Jafarzadeh, deputy director of the Washington office of the National Council of Resistance of Iran (NCRI), said newly released satellite images also prove the regime has accelerated its efforts to restore its “$2 trillion” uranium enrichment capabilities.

“The regime has clearly stepped up efforts to rebuild its uranium enrichment capabilities,” Jafarzadeh told Fox News Digital. “It is preparing itself for a possible war by trying to preserve its nuclear weapons program and ensure its protection.”

IRAN SAYS US MUST ‘PROVE THEY WANT TO DO A DEAL’ ON NUCLEAR TALKS IN GENEVA

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Reconstruction activity appears to be underway at Iran’s Isfahan nuclear complex. (Planet Labs PBC/Handout via Reuters)

“That said, the ongoing rebuilding of Iran’s uranium enrichment capabilities is particularly alarming as the regime is now engaged in nuclear talks with the United States,” he added.

New satellite images released by Earth intelligence monitor Planet Labs show reconstruction activity appears to be underway at the Isfahan complex.

Isfahan is one of three Iranian uranium enrichment plants targeted in the U.S. military operation known as “Midnight Hammer.”

The June 22 operation involved coordinated Air Force and Navy strikes on the Fordow, Natanz and Isfahan facilities.

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US POSITIONS AIRCRAFT CARRIERS, STRIKE PLATFORMS ACROSS MIDDLE EAST AS IRAN TALKS SHIFT TO OMAN

A satellite image shows tunnel entrances covered with soil at Isfahan nuclear complex. (Vantor/Handout via Reuters)

Despite the damage, the satellite images show Iran has buried entrances to a tunnel complex at the site, according to Reuters.

Similar steps were reportedly taken at the Natanz facility, which houses two additional enrichment plants.

“These efforts in Isfahan involve rebuilding its centrifuge program and other activities related to uranium enrichment,” Jafarzadeh said.

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The renewed movements come as Iran participated in talks with the U.S. in Geneva.

On Thursday, President Donald Trump warned that “bad things” would happen if Iran did not make a deal.

While the talks were aimed at curbing Iran’s nuclear program in exchange for sanctions relief, Jafarzadeh argues that for the regime, talks would be nothing more than a tactical delay.

TRUMP SAYS IRAN ALREADY HAS US TERMS AS MILITARY STRIKE CLOCK TICKS

Iran Supreme Leader Ayatollah Ali Khamenei “agreed to the nuclear talks as it would give the regime crucial time to avoid or limit the consequences of confrontation with the West,” according to Jafarzadeh. ( Office of the Supreme Leader of Iran via Getty Images)

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“Supreme Leader Ali Khamenei agreed to the nuclear talks as it would give the regime crucial time to avoid or limit the consequences of confrontation with the West,” he said.

Jafarzadeh also described the regime spending at least “$2 trillion” on nuclear capabilities, which he said “is higher than the entire oil revenue generated since the regime came to power in Iran in 1979.” 

“Tehran is trying to salvage whatever has remained of its nuclear weapons program and quickly rebuild it,” he said. “It has heavily invested in the nuclear weapons program as a key tool for the survival of the regime.”

IRANIAN OFFICIAL SAYS NUCLEAR TALKS WILL CONTINUE AFTER US, TEHRAN NEGOTIATIONS HAD ‘A GOOD START’ IN OMAN

Satellite imagery taken on January 30, 2026, shows a new roof over a previously destroyed building at the Natanz nuclear site. (2026 PLANET LABS PBC/Handout via Reuters)

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Jafarzadeh is best known for publicly revealing the existence of Iran’s Natanz nuclear site in 2002, which led to inspections by the International Atomic Energy Agency and intensified global scrutiny of Tehran’s nuclear ambitions.

“The insistence of the Iranian regime during the nuclear talks on maintaining its uranium enrichment capabilities, while rebuilding its damaged sites, is a clear indication that Supreme Leader Ali Khamenei has no plans to abandon its nuclear weapons program,” he said.

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The National Council of Resistance of Iran, led by Maryam Rajavi, exposed for the first time the nuclear sites in Natanz, Arak, Fordow and more than 100 other sites and projects, Jafarzadeh said, “despite a massive crackdown by the regime on this movement.”

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Tucker Carlson says passport seized, staff interrogated at Israeli airport

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Tucker Carlson says passport seized, staff interrogated at Israeli airport

Israeli officials deny detaining the right-wing figure, calling the questioning routine and conducted to ensure privacy.

Conservative United States podcaster Tucker Carlson has claimed Israeli authorities briefly took his passport and interrogated one of his crew members at the airport after the presenter conducted an interview with US ambassador Mike Huckabee, according to media reports.

In The Daily Mail and The New York Post, published on Wednesday, Carlson said that shortly after the interview with the diplomat, Israeli officials confiscated his passport and took one of his colleagues off to an interrogation room.

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“Men who identified themselves as airport security took our passports, hauled our executive producer into a side room and then demanded to know what we spoke to Ambassador Huckabee about,” Carlson reportedly said.

Israel rejected the reports. Oren Marmorstein, Israel’s Foreign Ministry spokesperson, said that the former Fox News host was “politely asked a few routine questions, in accordance with standard procedures applied to many travellers”.

“The conversation took place in a separate room within the VIP lounge solely to protect their privacy and to avoid conducting such a discussion in public,” he added.

Carlson travelled to Israel and conducted the interview at Ben Gurion International Airport without exiting the complex before returning to the US, Israeli media reported.

There were no comments or statements on the podcaster’s website or social media accounts.

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The interview was organised following a public spat between the two about an episode published by Carlson on the treatment of Christians in Israel. Huckabee responded by inviting the presenter to go to Israel and talk to him directly.

The podcaster, one of the most influential voices of the MAGA movement, has grown increasingly critical of Israel. His criticism has created a rift within the Republican party, which has for decades held unified and unequivocal support for Israel.

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