The US Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology.

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 criticised 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 on Tuesday.

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 $US500 million ($A707 million) in contracts and funding for the development of vaccines using mRNA.

A police boss has apologised to Muslim leaders after his officers dragged away men who were praying during a rally opposing the Israeli head of state’s visit.

Police were seen beating, pushing and pepper-spraying people at a protest in Sydney after Israeli President Isaac Herzog arrived in Australia on Monday.

Muslim men who were filmed kneeling and praying before being pushed and dragged away by police were not angry but instead “scared”, Australia’s special envoy to combat Islamophobia Aftab Malik said. 

The force’s actions were “disgraceful” and “appalling”, Mr Malik said.

NSW Premier Chris Minns has repeatedly defended police, saying they faced “incredibly difficult” circumstances.

But Mr Malik said he was brought to tears when the premier failed to call out a controversial line of questioning in a television interview that suggested the men had been “baiting” police when praying.

“The premier should have pushed back and said … ‘I don’t agree with that characterisation’, and had he said that, things would have been different,” he told the Senate on Tuesday night.

“But unfortunately, he responded the way he did, and this is part of the normalisation in which day-by-day, Muslims are being degraded  … it’s the ordinariness of Islamophobia destroying the dignity of Muslims who are legitimate citizens like anybody else.”

NSW Police Commissioner Mal Lanyon said he had apologised to senior members of the Muslim community for any offence caused.

But he also continued to defend the actions of police, who had been instructed to clear protesters from Sydney Town Hall.

Police could face legal action over their treatment of protesters. Footage of their behaviour has been widely circulating online and could cause reputational damage, one expert said.

“Civilians see this kind of violence so rarely in Australia, but when we do, it’s shocking,” University of Newcastle criminologist Justin Ellis told AAP.

“Police are going to have to deal with any reputational fallout.”

A message about safety, rather than officer tactics, could help reassure the public going forward, Dr Ellis said.

But the damage may already have been done.

Greens MP Abigail Boyd is considering legal action after she was struck by police.

Others could also take the police to court or make formal complaints, with video posted to social media showing a man with raised hands being punched repeatedly in the stomach by officers.

Former Greens candidate Hannah Thomas, who suffered a serious eye injury when she was arrested at a protest in 2025, had charges of resisting police dropped and an assault charge was laid against the constable who allegedly maimed her.

Lawyer Josh Bornstein said an independent probe into the protest policing was required.

“It’s difficult when police are the usual source of investigating criminal acts of violence, but we need some sort of independent investigation in this situation,” he told ABC TV.

Officers arrested 27 people on Monday and later charged nine with offences including behaving in an offensive manner in a public place and resisting police.

Five members of the public were hospitalised.

The violence has not deterred protesters in other parts of the nation from taking to the streets as Mr Herzog continues his Australian tour through Melbourne and Canberra.

Australia’s largest biopharmaceutical company has posted a massive slump in interim profit less than a day after the sudden retirement of its chief executive.

CSL’s first-half net profit fell 81 per cent to $US401 million, after government policy changes, one-off restructuring costs and impairments severely impacted its bottom line.

The healthcare giant’s underlying result, excluding those impacts, was down seven per cent to $US1.9 billion for the six months ended December 31.

“We are clearly not satisfied with our performance and have implemented a number of initiatives to drive stronger growth going forward,” CSL’s chief financial officer Ken Lim said in a statement on Wednesday.

“In the second half, we have an ambitious growth plan, driven by immunoglobulin, albumin and our newly launched products.”

The Australia-based CSL maintained its guidance for full-year revenue growth of between two to three pre cent and a four to seven per cent rise in underlying net profit.

Just as the Australian stock market was closing on Tuesday, CSL – which makes vaccines and blood plasma-derived therapies – suddenly announced chief executive Paul McKenzie was stepping down.

“When the board sat down recently and looked at our business and where we need to go in the future, we, in discussion with Paul, recognised he didn’t have the skills that we wanted for the future,” chairman Brian McNamee told analysts.

“We discussed this question of him therefore retiring.

“We need new and broader skills to improve performance commercially and also broaden our pipeline activities.”

Former CSL senior executive Gordon Naylor, a non-executive director of the company, has been appointed interim CEO and managing director.

CSL in October downgraded its 2025/26 earnings guidance due to falling US vaccination rates and reduced demand from China for the blood protein albumin.

Its shares were dumped in the final minute of trading after the Tuesday announcement, falling five per cent to $171.39, representing a 36.6 per cent drop over the past 12 months.

The shares had dipped in late September after President Donald Trump threatened to impose 100 per cent tariffs on pharmaceutical imports unless companies built manufacturing plants in the United States.

Ireland has rolled out a permanent basic income ‍scheme for the arts, pledging to pay 2000 creative workers more than $A500 per week following ​a trial that participants say eased financial strain and allowed them to spend more time ⁠on projects.

Ireland began the three-year trial in 2022 to help artists recover from COVID-19 shutdowns.

While similar pilots have been tried in San Francisco and New York, Ireland’s Culture Minister Patrick O’Donovan said the scheme was the first permanent one of its kind in the ‌world.

The move will “set ​Ireland apart from other countries with regard to how we value culture ‍and creativity,” O’Donovan said, launching the scheme in the James Joyce Room at Bewley’s Cafe, a Dublin cultural institution which hosts lunch-time theatre performances.

“This is a gigantic step forward that other countries are not doing.”

The randomly selected applicants will receive payments of 325 euros ($A550) a week for three years, after which they ​would not be eligible for the next three-year ‌cycle. 

O’Donovan said he would like to increase the number of recipients over time.

More than 8000 applicants applied for the ​2000 places in the pilot scheme.

A report on the trial concluded it lowered ‍the likelihood of artists experiencing enforced deprivation and reduced their levels of anxiety and reliance on supplementary income.

It also recouped more than the trial’s net cost of ​72 million ​euros through increases in ​arts-related expenditure, productivity gains and reduced reliance on ​other social welfare payments, according to a government-commissioned cost-benefit analysis.

“The scheme was a real-world test of what happens when people are given stability instead of precarity,” said composer and designer Peter Power, a member of the National Campaign for the Arts group.

“Artists on the scheme spent more time creating and less time trapped in unrelated jobs just to survive, and many became better able to ‍sustain themselves through their work alone.”

Liberal leadership aspirant Angus Taylor is expected to resign from the opposition frontbench to launch a spill against the party’s first female leader as pressure builds for a change at the top. 

Opposition Leader Sussan Ley escaped a challenge at Tuesday morning’s routine Liberal party room meeting but Mr Taylor will likely announce his intention to run for leadership as soon as Wednesday. 

A series of opinion polls revealing the coalition’s support hitting historic lows, including the most recent Newspoll on Monday, has prompted some Liberal MPs to privately push for a change. 

But Ms Ley’s backers, including moderate Liberal MP Maria Kovacic, have urged colleagues to publicly put their name to a petition calling for a spill so the party can move on. 

“We’ve had enough of what’s been going on over the past couple of months, it has spiralled out of control in the last few days,” she told ABC TV.

“Enough is enough. If you want this, put your name to it and get it over with.”

She said the ongoing turmoil was damaging the party’s credibility and ability to hold the Labor government to account.

“I don’t think (Australians) give a toss who the next leader is, because we haven’t actually showed them what we are going to do to make their lives better, and that is a failure,” Ms Kovacic said.

Liberal rules require anybody in a leadership position or in the shadow ministry to resign if they are part of a challenge. 

MPs can also request the leader call a special party room meeting to consider a leadership spill. 

If Ms Ley refuses to hold a meeting, Mr Taylor would need a petition endorsed by the majority of Liberal MPs and senators to force her hand.

In 2018, a petition was circulated to call for a party room meeting to resolve the leadership, which led to former Liberal prime minister Malcolm Turnbull being toppled by Scott Morrison.  

A special party room meeting is likely to be held on Thursday or Friday, once senators have finished with parliamentary committee hearings for the week.

Mr Taylor is confident he has the numbers to win a spill.

Mr Turnbull joined the calls for the conservative aspirant to “stand up and be counted”.

“This is a place where we vote in public right?” Mr Turnbull told reporters at Parliament House on Tuesday. 

“If Angus wants to be leader of the Liberal Party, he should stand up and say so and say why.”

Australia’s spy chief says his agency will own any mistakes following Bondi’s anti-Semitic terrorist attack as he revealed an external investigation cleared ASIO’s review of one of the gunmen in 2019. 

Naveed Akram and his father, Sajid, killed 15 innocent people and wounded dozens more during a shooting massacre at Bondi Beach in December during a Jewish Hanukkah festival.

Law enforcement alleges they were inspired by Islamic State ideology.

The father was shot dead by police at the time while the son faces terrorism and murder charges.

ASIO director general Mike Burgess said while ASIO and law enforcement partners had disrupted 28 major terrorism plots since September 2014, Australia’s intelligence agencies couldn’t catch everything.

He said the attack weighed heavily on him and his officers but this didn’t mean intelligence was ignored or people made mistakes. 

“The grim reality is, as I’ve said many times, ASIO is not all-seeing and all-knowing, we cannot stop every terrorist, just as we cannot catch every spy,” Mr Burgess told a parliamentary hearing on Tuesday night.

“It appears the alleged terrorists demonstrated a high level of security awareness to hide their plot. In simple terms, they went dark to stay off the radar.

“If ASIO is found to have made mistakes, we will own them, and we will learn from them.”

The director general said an external investigator had “unfettered and unfiltered access” to the agency to review whether there were any intelligence shortcomings.

It follows the younger Akram having come across ASIO’s radar in 2019 due to his association with others, but the then-teenager wasn’t deemed to present any ongoing threat.

Mr Burgess said the highly classified review into his agency following the Bondi attack reaffirmed ASIO’s actions in 2019.

“I can say that we stand by our 2019 assessment the Akrams did not adhere to or intend to engage in violent extremism at that time,” he said.

“In other words, many of the claims and criticisms being made about ASIO’s handling of the case are baseless.”

His public comments following an ABC Four Corners program aired on Monday, during which a former ASIO agent claimed he shared intelligence about Naveed’s radicalisation with the agency in 2019.

ASIO said it investigated the information but couldn’t substantiate it.

The intelligence agency further denied accusations that it failed to act on the former agent’s intelligence, saying his comments to the ABC were untrue, as he had attributed things to Naveed that were said and done by another person.

Mr Burgess also cautioned against applying hindsight.

“Things that might appear obvious in retrospect may not have been obvious at the time, and when individuals made decisions in one context, it may not be fair to judge them in a different context,” he told senators in the Tuesday hearing.

“In the days and weeks after the Bondi attack, assumptions, assertions, hypotheticals and opinions quickly became accepted as facts by some.

“They were recycled and exaggerated in the following weeks. This resulted in calls for action that were not supported by any fact.”

Police could face legal action after punching and pepper-spraying protesters during a rally against the Israeli president’s visit to Australia.

Officers were seen beating, pushing and deploying pepper spray at a Monday demonstration held after Israeli head of state Isaac Herzog arrived in the harbour city.

NSW Premier Chris Minns defended the actions of police and said they faced “incredibly difficult” circumstances.

But videos of officers from Monday night could embroil the force in a storm of reputational and legal trouble.

“Civilians see this kind of violence so rarely in Australia, but when we do, it’s shocking,” University of Newcastle criminologist Justin Ellis told AAP.

“Police are going to have to deal with any reputational fallout.”

A message about safety, rather than officer tactics, could help reassure the public going forward, Dr Ellis said.

But the damage may already have been done.

Greens MP Abigail Boyd is considering all of her options, including legal action, after she was shoved by police.

Others could also take the police to court or make formal complaints, with videos posted to social media showing a man with raised hands being punched repeatedly in the stomach by officers, while another depicted a group of Muslim men praying before being ripped from their knees and taken away by police.

The justice system can move in favour of protesters.

Former Greens candidate Hannah Thomas, who suffered a serious eye injury when she was arrested at a protest in 2025, had charges of resisting police dropped and an assault charge was laid against the constable who allegedly maimed her.

Officers arrested 27 people that night and later charged nine with offences including behaving in an offensive manner in a public place and resisting police.

Five members of the public were hospitalised.

The violence has not deterred protesters in other parts of the country from taking to the streets in coming days as Mr Herzog continues his Australian tour through Melbourne and Canberra.

During his two-day visit in Sydney, he met victims of the Bondi terrorist attack, students from Jewish schools and attended a ceremony at the Chabad of Bondi with Prime Minister Anthony Albanese.

Demonstrators will gather at the lawns of Parliament House in the nation’s capital on Wednesday to speak out against Israel’s offensive in Gaza.

ACT chief police officer Scott Lee said the territory’s force was trained to peacefully manage protests when questioned about the violent scenes in Sydney.

“Absolutely, I can provide you with that assurance,” he told a parliamentary hearing on Tuesday regarding the prospect of police violence.

Australia’s largest bank is set to report its financial results, six months after a similar earnings announcement sent its shares tumbling.

Commonwealth Bank will hand down its results for the six months to December 31 on Wednesday morning, an announcement that will be watched closely for what it says about its finances as well as the health of the banking sector and national economy.

Consensus estimates are for CBA’s revenue to grow 5.05 per cent year-on-year to $14.81 billion, while earnings per share are expected to rise 1.11 per cent year-on-year to $3.10.

After CBA posted its results for 2024/25 on August 13, its shares fell 5.4 per cent to $169.12, from $178.80. 

They have since remained under that level, changing hands on Tuesday afternoon at $159.17, down 0.45 per cent from Monday and down 10.9 per cent for the past six months.

That underperformance follows a period of stellar returns.

CBA shares hit a record high of $192 in June after changing hands around the $100 level from mid-2021 until late 2024.

IG analyst Tony Sycamore said the August 2025 sell-off came even as the bank posted solid numbers, including growing its full-year profit by 4.0 per cent to $10.25 billion and holding its net interest margin steady at 2.08 per cent.

“When you are priced for perfection, a result that is merely in line with expectations without a shiny earnings upgrade often feels like a letdown,” Mr Sycamore said.

There were also concerns about compression of its profit margin because of fierce competition for deposits, he said.

CBA’s first-quarter trading update on November 11 only added to investors’ worries despite the bank’s profit rising 2.0 per cent to $2.6 billion, Mr Sycamore said.

Its core earnings of $3.9 billion missed consensus by about two per cent, mostly because of unexpected costs, while its net interest margin was reported as slightly lower.

Net interest margin is used to gauge the profitability of banks, measuring the difference between the income generated from loans and the interest expenses paid to depositors.

Even with the roughly 20 per cent drop in CBA’s shares, it was still expensive, Morningstar market strategist Lochlan Halloway noted.

CBA was trading Tuesday at a price-to-earnings ratio of 26.7, making it the most expensive bank in the developed world according to market capitalisation.

Its Australian peers trade at a PE ratio in the teens, as does US banking giants such as Morgan Stanley and Bank of America.

Mr Sycamore said the market would look for reassurance that the sector remained healthy, with solid credit volumes, low bad debts and a robust capital position.

 “As the only big-four bank reporting in this cycle, CBA is the bellwether,” he said.

In analysing CBA’s earnings, Mr Halloway said Morningstar would focus on margin trade-offs used to support loan growth, progress in growing loans outside broker channels, and its deposit mix, particularly the low-cost transaction accounts that provided a funding advantage.

Struggling brand Gucci has dragged down luxury goods company Kering, with a decline in revenue in the final quarter of 10 per cent compared to the same period of the previous year, the company says.

The result came even though the brand’s revenue fell less on a comparable basis at the end of the year than in the third quarter.

Kering’s chief executive Luca de Meo, who has been in the job for only a few months, now wants to lead a turnaround in the business.

“The performance in 2025 does not reflect the Group’s true potential,” the former Renault chief executive said in a press release issued on Tuesday.

Measures have already been initiated in the second half of the year to strengthen the group’s financial position and reduce costs.

“On April 16, during our Capital Markets Day, we will present a clear roadmap to boost the desirability of our Luxury Houses and reignite growth, with well-defined brand strategies, a more effective organisation and strong financial discipline,” de Meo said.

The French company, which also owns brands like Yves Saint Laurent and Balenciaga, has lagged behind competitors in recent years.

It suffered from a decline in the popularity of Gucci products amid a general slowdown in luxury consumption, especially in China.

In 2025 alone, sales of Gucci products fell by more than a fifth to just under 6 billion euro ($A10 billion).

The group’s revenue dropped by 13 per cent to 14.7 billion euro.

The adjusted operating profit plummeted by a third to just over 1.6 billion euro.

The net profit attributable to shareholders shrank to 72 million euro, after generating a surplus of more than 1.1 billion euro the previous year.

Honda has reported a 42 per cent drop in profit for the nine months through December, compared with a year earlier, as US President Donald Trump’s tariffs hurt the Japanese auto maker’s earnings.

Tokyo-based Honda Motor Co’s profit over the three quarters totalled 465.4 billion yen ($A4.2 billion), down from 805.2 billion yen.

That marked the second straight year that profit declined during the period at Honda, the maker of the Accord sedan, Civic compact and Odyssey minivan.

Sales for the three quarters dipped 2.2 per cent to 15.98 trillion yen from the previous year. 

Honda stuck to its full fiscal year profit forecast at 300 billion yen. 

The slowdown in electric vehicles in the US market was one negative factor, according to Honda, while the relatively healthy performance in its motorcycle division worked as a plus. 

Honda lowered its global EV sales ratio projection for 2030 to 20 per cent from its previous target of 30 per cent. 

It also said it cancelled the development of some EV models, because the EV market was changing. 

The Trump administration, which has favoured the oil and gas industry, has back-pedalled on prior programs supporting the proliferation of EVs, dismantling programs that kicked in during the Biden administration, which had encouraged environmentally cleaner cars and trucks. 

In 2025, Trump lowered the tariffs on automobiles and auto parts to 15 per cent from an earlier 25 per cent that he had initially announced. 

Japan promised to invest $US550 billion ($A778 billion) in US projects.

Tariffs are a major blow to Japan’s export-reliant economy, including the auto makers. 

Last week, Japan’s top auto maker Toyota Motor Corp reported a decline in recent profit, and announced that its chief financial officer, Kenta Kon, would become its new chief executive and president.

Prime Minister Sanae Takaichi, who took office in October as Japan’s first female leader, scored a landslide parliamentary election victory for the governing party at the weekend. 

That is expected to make it easier for her Liberal Democratic Party to push forward on its policies, including bolstering growth by boosting government spending, especially in technology and defence.

Honda stock jumped 2.1 per cent in Tuesday’s trading. 

The Nikkei 225 benchmark finished 2.3 per cent higher, renewing a record high for the second day straight, in a rally set off, in part, by Takaichi’s popularity.