World

Moderna says FDA refuses its application for new mRNA flu vaccine

Published

4 weeks ago

February 10, 2026

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.

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.

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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World

One week into Iran war, the dangers for the US and Trump multiply

Published

16 minutes ago

March 7, 2026

Press Room

One week into Iran war, the dangers for the US and Trump multiply

One week into the U.S.-Israeli war against Iran that has plunged the Middle East into turmoil, President Donald Trump faces a growing list of risks and challenges that raise questions about whether he will be able to translate military successes into a clear geopolitical win.

World

Iran warns European countries will be ‘legitimate targets’ if they join conflict

Published

1 hour ago

March 7, 2026

Press Room

Iran warns European countries will be ‘legitimate targets’ if they join conflict

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An Iranian official warned that any European countries that enter the conflict against Iran will become “legitimate targets” for Tehran’s retaliation.

Iran’s Deputy Foreign Minister Majid Takht-Ravanchi made the remark to France24 as Iranian President Masoud Pezeshkian on Saturday apologized to neighboring countries that have been attacked by the regime.

“We have already informed the Europeans and everybody else that they should be careful not to be involved in this war of aggression against Iran,” Takht-Ravanchi told the network. “If they help, I’m not trying to name any country, but if any country joins in the aggression against Iran, joins America and Israel in the aggression against Iran, definitely they will be also the legitimate targets for Iranian retaliation.”

“This war has imposed on us, and we will continue to defend ourselves to the best of our abilities,” he added. “We have an obligation to defend our people and that is what exactly we are doing.”

Then-Iranian Ambassador to the United Nations Majid Takht-Ravanchi speaks to the media outside Security Council chambers at the U.N. headquarters in New York, on June 24, 2019. (Shannon Stapleton/Reuters)

Takht-Ravanchi also claimed Iran was “negotiating in good faith” in talks with the U.S. about its nuclear program, before America launched Operation Epic Fury and Israel began Operation Roaring Lion on Feb. 28.

“We are sincere. We are sincere in our endeavor to arrive at a peaceful conclusion of this issue,” he told France24.

AFTER THE STRIKES, HOW WOULD THE US SECURE IRAN’S ENRICHED URANIUM?

A group of men inspect the ruins of a police station struck during the U.S.–Israeli military campaign in Tehran, Iran, on Tuesday, March 3, 2026. (Vahid Salemi/AP)

Pezeshkian said Saturday that any future attacks coming out of Iran would only be in response to attacks against the country.

“I should apologize to the neighboring countries that were attacked by Iran, on my own behalf,” he said, according to The Associated Press. “From now on, they should not attack neighboring countries or fire missiles at them, unless we are attacked by those countries. I think we should solve this through diplomacy.”

Damage is seen in Bnei Brak, Israel, on March 3, 2026, following an Iranian missile barrage. (Nir Elias/Reuters)

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Pezeshkian made the apology during a prerecorded televised speech on Saturday after Iran launched repeated strikes on Bahrain, Saudi Arabia, the United Arab Emirates, Qatar and Oman.

Despite the vow, the United Arab Emirates (UAE) Ministry of Defense said on Saturday that the country’s air defense systems intercepted 16 ballistic missiles, 15 of which were destroyed while one fell into the sea.

Fox News Digital’s Elizabeth Pritchett and The Associated Press contributed to this report.

Greg Norman is a reporter at Fox News Digital.

World

Israel kills father, daughter in Gaza as genocide continues amid wider war

Published

3 hours ago

March 7, 2026

Press Room

Israel kills father, daughter in Gaza as genocide continues amid wider war

A father and his daughter have been killed in an Israeli drone attack in central Khan Younis, southern Gaza, as Palestinians continue to suffer amid worldwide attention on the United States-Israeli war on Iran.

The two were killed early on Saturday. In a separate attack later in the day in Khan Younis, another person was killed and a young girl wounded, according to Al Jazeera correspondents on the ground.

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Israeli forces continue carrying out air strikes, artillery shelling, and naval bombardment on Gaza on a daily basis, despite an October 11 “ceasefire” as Israel continues its ongoing genocide.

Suffering in Gaza and the occupied West Bank remains acute as the world focuses on the US-Israeli bombardment of Iran.

In the past 48 hours, two additional people have been wounded, the Palestinian Ministry of Health said.

Israeli army-affiliated militias, meanwhile, have advanced east of Gaza City, with heavy gunfire reported in the area. Initial reports also stated a member of the Palestinian police was abducted.

Israeli warplanes also struck several locations east of the Tuffah neighbourhood, near Gaza City, while the Israeli navy fired heavy machineguns and shells towards the coast of Gaza City, Palestinian news agency Wafa reported.

The Rafah border crossing, meanwhile, remains closed. Israel had shut it amid its attacks on Iran.

The Rafah crossing, located on Gaza’s southern border, had reopened only last month allowing a limited number of Palestinians to leave for the first time in months, including patients in urgent need of medical care. Thousands remain blocked from travelling for treatment.

The Karem Abu Salem crossing, also known to Israelis as Kerem Shalom, is partially open for the entry of humanitarian aid only, under strict restrictions.

Nearly all of Gaza’s population of more than two million people was displaced during Israel’s war on the territory, and the enclave remains heavily dependent on humanitarian assistance.

In a February report, Human Rights Watch said Israeli restrictions had contributed to shortages of medicine, reconstruction materials, food and water inside the Strip.

Since the ceasefire in Gaza, 640 Palestinians have been killed and at least 1,700 wounded, according to the Health Ministry. At least 72,123 Palestinians have been killed since October 2023, while 171,805 people have been injured.

Meanwhile, in the occupied West Bank, the Palestinian Red Crescent Society reported its teams in Hebron are treating a Palestinian injured by live fire near the illegal Karmei Tzur settlement, built on Palestinian land north of Hebron.

Three Palestinians were also injured on Saturday after being physically assaulted by Israeli settlers in the Ras al-Ahmar area, south of Tubas, Wafa reported. Medical sources at the Palestinian Red Crescent Society said their teams responded to three people with injuries.

Israeli forces also conducted raids in the towns of Qaffin and Kafr al-Labad, north of Tulkarem, early on Saturday, Wafa said.

A Palestinian man was also injured after being assaulted by Israeli soldiers near the village of Azmut, east of the occupied West Bank city of Nablus.

Palestinians have faced a wave of intensified Israeli military and settler violence across the West Bank since the war on Gaza began in October 2023.

At least 1,094 Palestinians have been killed by Israeli troops and settlers in the West Bank since October 2023, according to the latest United Nations figures.