US FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
May 31 (Reuters) - The U.S. Food and Drug Administration has approved Moderna's (MRNA.O), opens new tab next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements.
The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement.
The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season.
"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," CEO Stephane Bancel said in the statement.
The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines.
The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness.
The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives.
The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule.
The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots.
FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots.
Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine.
The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older.
The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study.
Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump's goal of dramatically shrinking the federal government. This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines.
The CDC's outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign.
The FDA approved Novavax's COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness.
Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC.
While Moderna's shots, as well as Pfizer-BioNTech's Comirnaty, are mRNA-based, Novavax's vaccine is protein-based and takes longer to manufacture.
Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
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The Independent
39 minutes ago
- The Independent
Trump administration denies wanting war with Iran or regime change after nuclear site bombing raid
Donald Trump's administration 'does not seek war' and is not trying to create regime change, US defense secretary Pete Hegseth has claimed after the president authorised a stunning attack on Iran. With the world reeling over the stealth bomber raids on three nuclear sites - dubbed 'Operation Midnight Hammer' - President Trump claimed he had 'completely obliterated' Iran's chances of obtaining nuclear weapons. UK and others into organising repatriation flights for citizens from Israel, Iran and surrounding countries amid fears of all-out war. Click here for the latest on the ongoing conflict. UK bases in Cyprus are on high alert with the theocratic regime in Tehran vowing revenge on America and her allies. Iran's foreign minister Abbas Araghchi announced he will fly to Moscow for meetings with Vladimir Putin on Monday. Meanwhile, Iran let off another barrage of missiles at Israel while US allies took stock of the latest round of international turmoil. Mr Trump's methods - which appear to have been kept secret from all but a close inner circle - were condemned by UN Secretary General António Guterres. In a statement, he said: 'I am gravely alarmed by the use of force by the United States against Iran today. This is a dangerous escalation in a region already on the edge – and a direct threat to international peace and security.' The attack came despite Mr Trump apparently assuring fellow G7 leaders in Canada last week that he was seeking de-escalation. UK prime minister Keir Starmer held an emergency Cobr meeting with senior members of the government in London but backed the president's sudden move. A similar security meeting took place in France chaired by president Emmanuel Macron. The two also joined German chancellor Friedrich Merz in an E3 joint call between the UK, France and Germany. UK foreign secretary David Lammy called other allies. But Mr Hegseth admitted that knowledge of the attack had been kept to a very small group within the administration and leaders of allies were only told about it when the bombers were on their way home. On a day of drama, the US defense secretary appeared with General Dan Caine, chairman of the joint chiefs of staff, at a press conference in the Pentagon. Seeking to appease anger among isolationists in Mr Trump's rightwing MAGA base, he praised the president's 'brilliant leadership'. "The operation President Trump planned was bold and it was brilliant, showing the world that American deterrence is back. When this President speaks, the world should listen," Mr Hegseth said. He admitted the operation with stealth B-2 bombers 'had been planned for weeks' and spoke of the 'deliberate deception' used to distract from Operation Midnight Hammer. This has led to speculation that Trump apparently agreeing to de-escalation at the G7 summit last week and giving Iran two weeks to get back to negotiations on Friday was in fact part of the deception. The US strikes included 14 bunker-buster bombs, more than two dozen Tomahawk missiles and over 125 military aircraft, in an operation the top U.S. general, General Caine. But despite the surprise attack overnight on Iranian nuclear sites, Mr Hegseth insisted America "does not seek war" and denied there was a desire to force regime change. Hegseth said it was important to note that U.S. strikes did not target Iranian troops or the Iranian people, a veiled effort to indicate to Iran that they don't want retaliation on American targets in the region. The operation pushes the Middle East to the brink of a major new conflagration in a region already aflame for more than 20 months with wars in Gaza and Lebanon and a toppled dictator in Syria. "Iran's nuclear ambitions have been obliterated," Hegseth told reporters in a briefing, adding that said the strikes did not target Iranian troops or people. iframe title="US attacks three of Iran's key nuclear facilities" aria-label="Locator map" id="datawrapper-chart-HBGvY" src=" scrolling="no" frameborder="0" style="width: 0; min-width: 100% !important; border: none;" height="524" data-external="1"> "The operation President Trump planned was bold and it was brilliant, showing the world that American deterrence is back. When this president speaks, the world should listen," Hegseth said. vice president J.D. Vance reiterated the message in a broadcast interview describing it as 'an incredibly targeted attack' but admitted it is 'an incredibly delicate moment.' He added that Iran responding by attacking US troops would be 'the stupidest thing in the world' which would be 'met with overwhelming force.' Offering Tehran advice he added: 'If the Iranians are smart they are going to have to look in the mirror and say 'maybe we are not so good at this war thing, let's give peace a chance, let's drop our nuclear weapons program and start to make some smart decisions.'' Earlier, Iran's regime vowed revenge and accused America of breaching international law. Iranian President Masoud Pezeshkian said: "This aggression showed that the United States is the primary instigator of the Zionist regime's hostile actions against the Islamic Republic of Iran. "Although they initially tried to deny their role, after our armed forces' decisive and deterrent response and the Zionist regime's clear incapacity, they were inevitably forced to enter the field themselves." Foreign Minister Mr Araghchi announced he would seek aid from Russia in person. "We enjoy a strategic partnership and we always consult with each other and coordinate our positions," he said, referring to Russia. The attack delighted Israel's prime minister Benjamin Netanyahu who had initiated military action against Iran more than a week ago claiming it was days away from having nuclear weapons. 'Congratulations, President Trump,' he said. 'Your bold decision to target Iran's nuclear facilities with the awesome and righteous might of the United States will change history... History will record that President Trump acted to deny the world's most dangerous regime the world's most dangerous weapons." An Israeli official has suggested that Iran had enough uranium for nine nuclear bombs and could have turned it to weapons grade level 'in a matter of days.' Former UK security minister Tom Tugendhat pointed out that if Iran had been successful it could have hit London with nuclear armed ballistic missiles. But leftwing MPs in the UK including independent former Labour MP Zara Sultana accused the US of 'warmongering' and the UK of 'acting like an American poodle'. Sir Keir gave his support for the raid saying Iran should 'never be allowed nuclear weapons'. In a statement the prime minister said: 'Iran's nuclear programme is a grave threat to international security. Iran can never be allowed to develop a nuclear weapon and the US has taken action to alleviate that threat. 'The situation in the Middle East remains volatile and stability in the region is a priority. We call on Iran to return to the negotiating table and reach a diplomatic solution to end this crisis'.
Reuters
43 minutes ago
- Reuters
US bombing of Iran started with a fake-out
WASHINGTON, June 22 (Reuters) - As Operation "Midnight Hammer" got underway on Saturday, a group of B-2 bombers took off from their base in Missouri and were noticed heading out toward the Pacific island of Guam, in what experts saw as possible pre-positioning for any U.S. decision to strike Iran. But they were a decoy. The real group of seven bat-winged, B-2 stealth bombers flew east undetected for 18 hours, keeping communications to a minimum, refueling in mid-air, the U.S. military revealed on Sunday. As the bombers neared Iranian airspace, a U.S. submarine launched more than two dozen Tomahawk land attack cruise missiles. U.S. fighter jets flew as decoys in front of the bombers to sweep for any Iranian fighter jets and missiles. The attack on Iran's three main nuclear sites was the largest operational strike ever by B-2 stealth bombers, and the second-longest B-2 operation ever flown, surpassed only by those following the September 11, 2001, attacks on the United States by al Qaeda. The B-2 bombers dropped 14 bunker-busting GBU-57 Massive Ordnance Penetrators, each weighing 30,000 pounds. The operation involved over 125 U.S. military aircraft, according to the Pentagon. From the U.S. military's perspective, the operation was a resounding tactical success. The Iranians were unable to get off a single round at the American aircraft and were caught completely flat-footed, General Dan Caine, the chairman of the Joint Chiefs of Staff, told reporters at the Pentagon on Sunday. "Iran's fighters did not fly, and it appears that Iran's surface to air missile systems did not see us throughout the mission," Caine said. "We retained the element of surprise." Caine said initial battle damage assessments indicated that all three sites targeted sustained extremely severe damage and destruction, but he declined to speculate whether any Iranian nuclear capabilities might still be intact. U.S. Defense Secretary Pete Hegseth was more confident. "It was clear we devastated the Iranian nuclear program," he said, standing alongside Caine in the Pentagon briefing room. Midnight Hammer was highly classified, Caine said, "with very few people in Washington knowing the timing or nature of the plan." Many senior officials in the United States only learned of it on Saturday night from President Donald Trump's first post on social media. Hegseth said it took months of preparations to ensure the U.S. military would be ready if Trump ordered the strikes. Caine said the mission itself, however, came together in just a matter of weeks. What happens next is unclear. Gulf states, home to multiple U.S. military bases, were on high alert on Sunday as they weighed the risks of a widening conflict in the region. Guarding against blowback, the U.S. military also dispersed U.S. military assets in the Middle East and heightened force protection for U.S. troops. Hegseth said the U.S. military was positioned to defend itself in the Middle East, but also to respond against Iran if it goes through with longstanding threats to retaliate. The Trump administration said it is not looking for a wider war with Iran, with Hegseth saying private messages had been sent to Tehran encouraging them to negotiate. But Trump has also warned Iran that the U.S. is prepared to hit additional targets if needed, using far greater force. "Iran would be smart to heed those words. He said it before, and he means it," Hegseth said.
The Independent
an hour ago
- The Independent
After Trump rebuked her on Iran, Tulsi Gabbard left out of Situation Room photos of Midnight Hammer strikes
Photos of President Donald Trump's Situation Room released by the White House in the hours since he authorized a U.S. strike on Iranian nuclear facilities, appear to hide the participation of one key member of his military and intelligence apparatus. The photos show Trump in a red MAGA cap watching the proceedings while surrounded by his top officials. Vice President JD Vance, Secretary of State Marco Rubio, and Defense Secretary Pete Hegseth were all shown taking part. But U.S. Director of National Intelligence Tulsi Gabbard was nowhere to be found in the images. It seems unlikely that Gabbard's absence from the situation room photo release is a coincidence, considering the president has repeatedly tossed her under bus on the very issue of Iran the past week. According to a New York Times report, Gabbard has been in trouble with Trump since the start of the month. Earlier in June, Gabbard posted a video on social media talking about a trip she took to Hiroshima, Japan and sharing a warning against war in an age when nuclear weapons threaten global annihilation. 'As we stand here today, closer to the brink of nuclear annihilation than ever before,' she says in the video. The clip continues, with Gabbard warning that "political elites and warmongers are carelessly fomenting fear and tension between nuclear powers." Trump reportedly had a problem with her comments. According to sources who spoke to the Times, Trump took Gabbard's video as a sign she was only using her time in his White House as a stepping stone. He reportedly told her if she wanted to run for president then she shouldn't be in his administration. His issues with Gabbard — who according to CBS was among the officials in the Situation Room Saturday — became more obvious after Trump was forced to respond to testimony she gave in March in which she said Iran was not pursuing nuclear weapons through its refinement efforts. "She's wrong," Trump told reporters on Friday after he landed in New Jersey. It wasn't the first time he dismissed her commentary either; Trump told another reporter on Monday during an Air Force One flight that "I don't care what she says" after he was asked about Gabbard's testimony. During his Friday comments, Trump made clear any action the U.S. took would be under the pretense of stopping Iran from creating a nuclear weapon. 'It looks like I'm right about the material that they've gathered already. It's a tremendous amount of material. And I think within a matter of weeks, or certainly within a matter of months, they were going to be able to have a nuclear weapon," Trump said. "We can't let that happen.' After the strike, Hegseth told reporters that Trump had looked at the intelligence he reportedly had received about Iran's nuclear ambitions and acted. "I would just simply say that the president's made it very clear he's looked at all of this, all of the intelligence, all the information, and come to the conclusion that the Iranian nuclear Program is a threat," Hegseth told reporters on Sunday. "He looked at all of it, understood the nature of the threat, and took bold action." On Friday — the same day Trump threw her under the bus — Gabbard broadly pointed to unspecific 'intelligence' justify why she was flipping from her own testimony in March in order to back Trump's Iran agenda. On X, she claimed that the "dishonest media" was "intentionally taking my testimony out of context and spreading fake news as a way to manufacture division." She also insisted — despite saying Iran was not pursuing nuclear weapons in March — that the U..S. had intelligence saying that Iran "can produce a nuclear weapon within weeks to months, if they decide to finalize the assembly." "President Trump has been clear that can't happen, and I agree," Gabbard wrote. Unfortunately for Gabbard, it seems like she started playing Trump ball a little too late to get invited to the situation room on Saturday night.
