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.

Police clashed with anti-Israel demonstrators in Sydney during protests against Israeli President Isaac Herzog’s visit to Australia, prompting national leaders to urge calm and call for demonstrations to remain peaceful. 

Police said 27 people were arrested, including 10 for allegedly assaulting officers, after violence broke out Monday evening when authorities moved to clear thousands of protesters gathered near Sydney’s Town Hall.

The unrest unfolded as Herzog arrived in Australia for a visit centered on solidarity with the Jewish community after the Dec. 14 terror attack at a Hanukkah event in Bondi Beach that killed 15 people.

FORMER AUSTRALIAN MINISTER SAYS ‘RADICAL ISLAM PULLED THE TRIGGER’ IN AUSTRALIA’S WORST TERROR ATTACK

Herzog traveled to Bondi during the trip, where he met bereaved families and participated in memorial events honoring the victims. In a post on X, he wrote, “Together with Prime Minister Anthony Albanese and the community’s leader, Rabbi Yehoram Ulman, bereaved families, and members of the Jewish community, we united in memory of the 15 victims of the Bondi terror attacks. The terrorists sought to instill fear in the Jewish people—and we respond with renewed Jewish pride, by choosing life and hope.”

Herzog also warned of rising antisemitism during the visit, calling it a global emergency and defending Israel’s actions in Gaza when asked about the protests.

Demonstrations opposing Israel’s war in Gaza and Herzog’s presence erupted across Australia, with the largest confrontation unfolding in Sydney. Authorities imposed restrictions on protest routes and used pepper spray to disperse crowds after tensions escalated.

Police said officers were met with violence and acted to maintain order, while protesters and some politicians accused authorities of excessive force.

Talking to Sky News Australia, former Australian Jewish Association president David Adler called the violence “a disgraceful display,” noting that Australia has a system of law and order and that a court decision establishing an exclusion zone for the protests was ignored by the “radical activists,” which “left the police with an impossible situation.”

Commenting on Sydney police actions against the agitators, Adler said there was some “rejoicing in our community to finally see a bit of pushback from the New South Wales police, because, for two years and a half, almost, there’s been a lack of law enforcement when it comes to the incitement, the antisemitism and we’ve seen the emboldenment and the dreadful incidents which have occurred right across the country culminating (on Dec. 14) with the massacre at Bondi Beach. So maybe we’ve seen a little bit of a flicker of pushback in law enforcement, which we certainly welcome,” he said.

AUSTRALIA BANS PRO-ISRAEL INFLUENCER WEEKS AFTER BONDI BEACH TERROR ATTACK

Andrew Wallace, a member of parliament said, “Australians who live in a democracy have a right to protest peacefully and lawfully,” Wallace told Sky News, “What we saw last night was not peaceful, and it certainly was not in accordance with directions given by police.”

Australian leaders called for restraint and warned against importing overseas conflict into domestic streets.

A timeline compiled by the American Jewish Committee notes that the December Bondi Beach attack came after a sustained rise in anti-Jewish threats and violence across Australia, including vandalism of synagogues and Jewish schools, arson attacks and public harassment since Oct. 2023. The Executive Council of Australian Jewry documented more than 1,600 anti-Jewish incidents between Oct. 2024 and Sept. 2025, following more than 2,000 incidents the previous year.

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Israeli leaders have pointed to the Bondi attack as evidence of growing risks facing Jewish communities abroad and have criticized Australian authorities for failing to prevent the terrorist attack.

Published on
11/02/2026 – 7:00 GMT+1

Political groups of the European Parliament reached an agreement on Tuesday on the EU-US trade deal, which was struck in July 2025 by US President Donald Trump and European Commission President Ursula von der Leyen and still needs to be ratified.

The agreement sets US tariffs at 15% on EU exports, while the EU committed to cutting its tariffs on US goods to zero, but its approval has proven controversial in recent weeks due to Trump’s threats to take control of Greenland.

The Parliament froze the approval process in January after Trump said on social media that he would impose a 10% tariff from February on eight European countries for having taken part in a military mission in the Arctic.

Works resumed a few weeks later, with representatives of the Parliament’s political groups fine-tuning the details of the legislation needed to implement the deal.

The final compromise they have reached will be formally voted on by the International Partnership Committee on February 24 and by a Plenary session as early as March.

It includes a “sunset clause”, which would see EU tariff relief expire at the end of March 2028, unless explicitly renewed, and a “suspension clause”, which would be activated in the event the US violates the deal’s rules.

“After the Greenland issue, we introduced a clear criterion for the territorial sovereignty of the European Union, to the set of criteria for a possible suspension”, said Socialist MEP Bernd Lange, lead negotiator on the file.

The Parliament’s version of the trade deal will also feature a safeguard mechanism to address the impact the reduction of tariffs for US goods could have on the EU market.

It also includes an automatic reintroduction of tariffs if the US does not reducing its own tariffs to 15% for a list of more than 400 steel-related products, which was agreed last July but which has not yet happened.

After the final vote in the plenary session, the Parliament will have to negotiate the terms of the agreement with the EU countries, and some of the conditions may change.