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Moderna seeks emergency use authorization for Covid-19 vaccine for children ages 6 months through 5 years

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Moderna seeks emergency use authorization for Covid-19 vaccine for children ages 6 months through 5 years

“We consider mRNA-1273 will be capable of safely defend these youngsters in opposition to SARS-CoV-2, which is so vital in our continued struggle in opposition to COVID-19, and can be particularly welcomed by dad and mom and caregivers,” Stéphane Bancel, chief govt officer of Moderna, mentioned in a information launch.

In late March, Moderna introduced outcomes of a scientific trial that included 2,500 youngsters ages 6 months via 24 months and 4,200 youngsters ages 2 via 5. The corporate mentioned that two 25-microgram doses of its vaccine led to the same immune response in younger youngsters as two 100-microgram doses for adults ages 18 to 25. And it mentioned this could predict safety from Covid-19 and extreme Covid-19 down to six months of age.

In Thursday’s information launch, the corporate mentioned the info confirmed “a sturdy neutralizing antibody response” and “a positive security profile.”

“We prefer to see something above 1,000 items, and what we, in reality, noticed listed here are ranges someplace between 1,400 and 1,800 items,” Dr. Paul Burton, chief medical officer of Moderna, mentioned Wednesday. “In order that’s extraordinarily reassuring.”

Burton additionally mentioned the vaccines had been very protected for this age group. The commonest reactions had been ache on the injection web site and fever. There have been no circumstances of coronary heart irritation, or myocarditis, within the examine. Coronary heart irritation has been a particularly uncommon aspect impact of the mRNA vaccines. Myocarditis is extra frequent after Covid-19 an infection than after vaccination.

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The outcomes introduced in March had been largely collected throughout the Omicron wave, and included dwelling testing for Covid-19. Because of this, the corporate mentioned the vaccines appeared much less efficient for kids than they did for older age teams.

The info introduced by Moderna Thursday restricted the evaluation solely to circumstances confirmed constructive by delicate reverse transcription-polymerase chain response checks. Within the revised evaluation, the vaccines had been 51% efficient at stopping signs in youngsters ages 6 months to beneath 2 years; they had been 37% efficient at stopping signs in youngsters ages 2 via 5. The corporate mentioned these efficacy estimates are just like these amongst adults in opposition to Omicron after two doses.

Pfizer/BioNTech’s Covid-19 vaccine for younger youngsters has additionally stumbled. In scientific trials, two 3-microgram doses did not seem to generate the identical diploma of immunity for kids ages 2 via 4 as that they had for younger adults, prompting the corporate to take a look at giving youngsters ages 6 months via 4 years a 3rd dose. The FDA additionally delayed its evaluation of those photographs till the corporate submits information on a 3rd dose.

Boosters for youthful youngsters?

On Tuesday, Pfizer requested the FDA to green-light a 3rd or booster dose for kids ages 5 via 11. Research have proven that vaccine efficacy has waned considerably on this age group throughout Omicron.
Pfizer requests FDA authorization for Covid-19 booster for kids 5 through 11

Burton mentioned Wednesday that that Moderna was additionally testing boosters, together with variant-specific formulations.

“Our lead candidate now could be one thing in opposition to the unique pressure and Omicron,” he mentioned, predicting that will be the booster formulation for the autumn and winter.

“And I feel for these younger youngsters, what we’ll should do is to proceed to observe the pure historical past and see, what’s the variant? What is going on on with the little youngsters as we get into the autumn? After which the FDA and CDC and regulators all over the world could make suggestions on whether or not they want one other booster later within the yr.”

What’s subsequent for vaccines for youthful youngsters

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No Covid-19 vaccines have been licensed for kids youthful than 5 within the US — about 18 million folks.

Moderna’s mRNA Covid-19 vaccine is allowed for folks 18 and older and Pfizer/BioNTech’s for five and older.

The FDA will consider Moderna’s submission and has mentioned it’s going to convene its Vaccines and Associated Organic Merchandise Advisory Committee to weigh in on vaccine authorization for youthful youngsters.

Nationwide Institute of Allergy and Infectious Illnesses Director Dr. Anthony Fauci has mentioned that the FDA is weighing whether or not to contemplate emergency use authorization for each the Moderna and Pfizer/BioNTech Covid-19 vaccines for younger youngsters on the identical time, slightly than contemplating them individually.

Pfizer has mentioned the info on a 3rd dose of the vaccine can be out there this month. Pfizer CEO Albert Bourla mentioned the vaccine for youthful youngsters may very well be out there in June, If the FDA authorizes it.

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CNN’s Jamie Gumbrecht contributed to this report.

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This year will likely be the last major D-Day anniversary with living veterans, so organizers are all-out | CNN

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This year will likely be the last major D-Day anniversary with living veterans, so organizers are all-out | CNN

Editor’s Note: As the 80th anniversary of D-Day nears, the global fight for democracy continues. CNN Anchor and Chief Washington Correspondent Jake Tapper speaks with World War II veterans and military generals about the worldwide erosion of democratic institutions. “D-Day: Why We Still Fight for Democracy” premieres Sunday, June 2 at 8 p.m. ET/PT on CNN.


Caen, France
CNN
 — 

At 99 years old, Jack Foy is considered the youngster among his group of friends that fought in World War II.

But their advanced age isn’t going to stop them from making the transatlantic journey to honor their fallen comrades on the 80th anniversary of D-Day.

On June 6, Foy – a survivor of the Battle of the Bulge – and his fellow American veterans will join dignitaries and heads of state from around the world to commemorate the approximately 160,000 Allied troops who, eight decades ago, carried out the largest seaborne invasion in human history.

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Foy told CNN that he has been to several memorials in France since 2014. The emotional resonance of each trip grows stronger year after year, he said, because these veterans know each trip could be their last.

“We realize we’re getting to the end of our time,” Foy said.

They are not alone.

With major commemorations held every five years, organizers and government officials concede that this year’s event could be the last to involve living veterans, whose stories of the horrors of war have become particularly poignant given that Russia’s invasion of Ukraine has brought a large-scale ground war back to Europe for the first time since 1945.

“We are perfectly aware that for these centenarians, this is maybe the last chance to return to the beaches where they landed, where they fought and where their brothers-in-arms fell,” said Gen. Michel Delion, the CEO of the French government agency in charge of the French commemoration efforts, Mission Liberation.

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The various countries putting together the event are now planning what is expected to be the most extensive D-Day commemoration in history – both in terms of size and, crucially for elderly veterans, logistics.

Approximately 150 American veterans are expected to travel to Normandy – about two dozen of whom actually fought on D-Day – said Charles Djou, the secretary of the American Battle Monuments Commission (ABMC), the independent agency responsible for managing US military cemeteries and monuments overseas. The youngest is 96.

Fifteen Canadian veterans, including three or four that fought on D-Day, are traveling with the Canadian delegation, according to John Desrosiers, the director of international operations for Veterans Affairs Canada. Desrosiers said the youngest traveling with the group is 98 and the eldest are 104.

The British defense ministry said it expects more than 40 WWII veterans at the various events in Normandy.

US D-Day veterans attend an event at the Normandy American Cemetery and Memorial as part of the 79th anniversary D-Day celebrations on June 6, 2023.

Those vets will be joined by about 25 heads of state and government, including US President Joe Biden, British Prime Minister Rishi Sunak and Canadian Prime Minister Justin Trudeau. Russian President Vladimir Putin was not extended an invitation due to the war in Ukraine, while Ukrainian President Volodymyr Zelensky is planning on attending, according to a French presidential source.

With so many heads of state in town, the security measures in place are intense. A massive contingent of 12,000 security personnel will be deployed on June 6, the French Interior Ministry said.

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Heavy travel restrictions put in place by French authorities will also effectively cut off the Norman coastline and the normally sleepy towns that dot it from the rest of the country.

Yet June 6 typically sees these elderly men criss-cross the region to hit a full day’s itinerary, including national ceremonies held at the American, British and Canadian cemeteries; the big international commemoration put on by France; and then, if they have the energy, more local events.

Most veterans also travel with an entire phalanx of medical personnel. The charity that organized Foy’s trip, the US-based Best Defense Foundation, is bringing three doctors and 10 nurses to accompany the 50 veterans they are flying over from the United States. Each veteran will travel with a personal caregiver – typically a family member or a friend.

Officials say they are going to incredible lengths to treat veterans like royalty – as they are feted by actual royals. King Charles III will be there on June 6 – his first overseas trip since being diagnosed with cancer – alongside Queen Camilla and Prince William, Buckingham Palace said. Representatives from the royal families of Belgium, Monaco, the Netherlands and Norway are also expected to attend.

Delion’s team has been holding rehearsals and timing wheelchair runs for the French-led international ceremony. They are also considering having veterans enter at the same time as heads of states and other dignitaries to reduce their waiting time.

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American and Canadian organizers told CNN that they will seat veterans last at their respective national ceremonies to keep them comfortable. The general public at the American event, for example, may need to be seated about an hour in advance due to security precautions.

“We take care of the veterans who served and made the enormous sacrifices that they did in the Second World War,” said Djou.

British D-Day veteran Tom Schaffer (left), and companion John Pinkerton study the names on the British Normandy Memorial at Ver-sur-Mer in France ahead of the 79th anniversary of the D-Day landings in June 2023. Schaffer passed away in March 2024, at the age of 97.

After being postponed 24 hours due to bad weather, D-Day began shortly after midnight on June 6, 1944, when paratroopers dropped into German-occupied France to lay the groundwork for the incoming invasion. Allied planes and warships began their bombardment at about 6:30 a.m., with troops hitting the beaches shortly after. They landed on a stretch of coastline 50 miles long organized into five beaches codenamed Gold, Juno, Omaha, Sword and Utah. The Americans were responsible for Omaha and Utah. The British led the assault on Gold and Sword, while the Canadians handled Juno.

Though 4,414 Allied troops died that day and it would take more than a month to achieve one of D-Day’s main objectives – liberating the strategically important city of Caen – the landings were considered a success. Allied troops had successfully made it onshore in France; it was the beginning of the end for Hitler and Nazi Germany.

American troops march up from Omaha Beach on June 18, 1944.

The sheer drama of the event has, for decades, captured the American public imagination, because of both the magnitude of the invasion and the fact that it was a “digestible” turning point in the war, according to Ben Brands, a military historian at the ABMC.

“World War II, especially in Europe, becomes this ongoing battle from basically the moment troops land on the beaches of D-Day until Germany ultimately surrenders. The human mind needs to cut that up into digestible stories, and D-Day is a really powerful, discrete event that is so critical for everything that comes after,” Brands said. “There’s just so many powerful stories that come out of D-Day.”

US military personnel place US and French flags next to the graves of fallen soldiers at the Normandy American Cemetery on June 5, 2023 in Colleville-sur-Mer, France.

As time has passed, veterans have played a crucial role in passing down the stories of D-Day. Their gripping, visceral first-hand accounts are better teachers of history than any textbook.

But just a fraction of the soldiers who lived through D-Day are still alive.

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Of the 16.4 million Americans who served in the military during WWII, fewer than 100,000 are expected to still be alive by the end of the year, according to statistics from the US Department of Veterans Affairs. In Canada, there were just 9,297 living Canadian veterans who had served in either WWII or the Korean War as of March 31, 2023, according to the most recent statistics available from Veterans Affairs Canada. The British defense ministry said it does not keep veteran numbers on hand.

It’s unclear what the average age of a WWII veteran is. Given that the median age for an American WWII veteran in June 2020 was 93, according to US Census figures at the time, most surviving vets from Allied forces are likely to now be at least in their late-nineties. By the 85th anniversary in 2029, those who are still living will almost certainly be in triple digits.

“People are realizing this generation is passing and they’re passing rapidly now, and it’s important to keep their stories alive, to keep the memories of those who died and are buried at Normandy, but also those who fought and survived because they can no longer be with us for that much longer to tell these stories,” Brands said.

“The 80th will be a very powerful event.”

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Ministers threaten to bring down Israeli government over ‘reckless’ Gaza ceasefire plan

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Ministers threaten to bring down Israeli government over ‘reckless’ Gaza ceasefire plan

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Right-wing allies of Benjamin Netanyahu have rejected a US-brokered ceasefire proposal to end the war in Gaza as “total surrender” to Hamas, threatening to bring down the Israeli government if it is enacted.

US President Joe Biden unveiled the contours of a deal on Friday in which the fighting would be halted and Israeli hostages held in Gaza released. The ultimate goal, Biden said, would be an end to the conflict.

After the end of the Sabbath on Saturday night, two senior far-right ministers in Netanyahu’s ruling coalition warned the long-serving premier against accepting the “reckless” deal and urged him to continue the war until the “complete elimination” of Hamas.

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The proposal would be “a victory for terrorism and a security danger to the State of Israel,” National Security Minister Itamar Ben-Gvir said in a statement.

“Agreeing to such a deal is not total victory — but total defeat,” he added, threatening to “dissolve the government”.

Bezalel Smotrich, finance minister, said he would not be part of a government that agreed to “end the war without destroying Hamas and returning all the hostages”. He criticised proposals to withdraw the Israeli military from Gaza, release Palestinian prisoners held in Israeli jails, and return displaced Gazans to their homes in the north of the shattered enclave.

“We demand the continuation of the fighting until the destruction of Hamas and the return of all the hostages,” he said.

The US, along with Egypt and Qatar, issued a joint statement on Saturday calling on both Hamas and Israel to finalise the terms of the deal as Biden had outlined. All three states have for months attempted to broker an agreement that would halt the fighting in Gaza, but talks have stalled over fundamental gaps between the two warring parties — in particular over whether any ceasefire would be permanent.

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In their statement, the three countries added that the proposal “will bring immediate relief both to the long-suffering people of Gaza as well as the long-suffering hostages and their families. This deal offers a road map for a permanent ceasefire and ending the crisis.”

According to Biden, the three-phase agreement would begin with a “full and complete ceasefire” over six weeks, including the withdrawal of Israeli forces from “densely populated” areas of Gaza, and the return of some hostages, including Americans, alongside the release of some Palestinian prisoners.

A second phase would involve the release of all hostages and a “permanent cessation of hostilities” combined with a full withdrawal of Israeli troops from Gaza.

The third phase would relate to the “reconstruction” of Gaza, designed to lead to broader stabilisation in the Middle East.

Netanyahu’s office have issued two non-committal statements, saying that “Israel’s conditions for ending the war have not changed: the destruction of Hamas’s military and governing capabilities, the freeing of all hostages and ensuring that Gaza no longer poses a threat to Israel.”

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Netanyahu’s office added that it would “insist these conditions are met before a permanent ceasefire is put in place. The notion that Israel will agree to a permanent ceasefire before these conditions are fulfilled is a non-starter.”

Hamas said in a statement that it “positively views” Biden’s speech and that it was ready to deal “in a constructive manner with any proposal that is based on a permanent ceasefire and the full withdrawal [of Israeli forces] from the Gaza Strip, the reconstruction [of Gaza], and the return of displaced people to their homes, along with the completion of a genuine prisoner swap deal”, as long as Israel “clearly announces commitment to such a deal”.

With pressure mounting within Netanyahu’s own coalition and right-wing base against the ceasefire proposal, opposition leader Yair Lapid on Saturday again offered to provide a “safety net” to the ruling coalition in the event that Ben-Gvir and Smotrich pulled out their parties.

“The Israeli government cannot ignore President Biden’s significant speech. There is a deal on the table and it needs to be done,” Lapid wrote on X.

Tens of thousands of Israelis converged in central Tel Aviv on Saturday night in the weekly demonstration for the release of the Israeli hostages seized by Hamas during its October 7 attack that triggered the war. Some 125 are still being held, with about a third believed by Israeli officials to be dead.

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“Yes to the Netanyahu Deal! Bring them home now!” they yelled.

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Chad Daybell is sentenced to death in Idaho 'zombie murder' trial

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Chad Daybell is sentenced to death in Idaho 'zombie murder' trial

Chad Daybell sits at the defense table after the jury’s verdict in his murder trial was read at the Ada County Courthouse in Boise, Idaho, on Thursday.

Kyle Green, Pool/AP


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Kyle Green, Pool/AP

A jury in Boise, Idaho, sentenced Chad Daybell to death on Saturday for the murders of his former wife and his second wife’s two youngest children.

As the judge handed down the death penalty, Daybell stayed still and showed no emotion.

The sentencing came two days after Daybell was found guilty of first-degree murder in the 2019 death of his former wife, Tammy Daybell, 49. He was also found guilty of conspiracy charges in the deaths of his second wife, Lori Vallow Daybell’s two youngest children, Tylee Ryan and Joshua Jaxon “JJ” Vallow.

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Tylee was nearly 17 when she and JJ, 7, were last seen alive in September 2019 — the same month they had moved with their mother from Chandler, Ariz., to Rexburg, Idaho.

Prosecutors had said they were seeking the death penalty for Daybell if he was convicted. In such cases, the jury hears from the two sides about any aggravating and mitigating circumstances, before deciding whether a death sentence is appropriate.

Prosecutors said Daybell concocted wild, religion-tinged fantasies about people becoming zombies to justify grisly crimes — with the goal, they said, of starting a new life with his second wife, Vallow Daybell, after having an affair with her. They also accused Daybell of insurance fraud in his former wife’s death.

Prosecutor said texts show Tammy was “in the way”

Tammy Daybell, Chad’s then-wife, was found dead in her home in October 2019. The librarian and educator was 49. A coroner did not initially perform an autopsy, saying a heart attack was the apparent cause of death. But suspicions later led Tammy’s body to be exhumed, and the cause of death was changed to homicide: asphyxiation by suffocation.

In her closing argument this week, Fremont County Prosecutor Lindsey Blake said Chad Daybell influenced the coroner’s initial ruling by fabricating details about Tammy’s medical condition. It was all part of a plan, Blake said, for Chad to eliminate his wife so he could be with Lori Vallow. Months earlier, Vallow’s brother had shot and killed her husband, Charles.

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“A little over 24 hours from reporting his wife’s death,” Blake said in her closing argument, “Chad messages Lori: ‘I know exactly how you feel. I’m feeling sad, but it isn’t for the reason everyone thinks!’”

At the time, Vallow was on a trip to Hawaii. Blake said Vallow had grown frustrated with Daybell, sending him a text saying they couldn’t be together until things changed.

“What needs to change?” the prosecutor asked the jurors. “Tammy’s in the way.”

Daybell responded to Vallow’s message, Blake added, by saying that being with Vallow was the only thing that mattered to him.

“Lori manipulates Chad with sex,” Blake said. “From the minute he met her, he wanted to be with her — and she knew it.”

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Two children were found buried on Daybell’s property

Blake also described how Vallow began asking Daybell about possible plans involving Tylee and JJ.

“About a month after Charles’ passing, Lori’s asking Chad, ‘Do you think there is a perfectly orchestrated plan to take the children?’” Blake said, displaying an image of Vallow’s text message to Daybell in court.

“There is a plan being orchestrated for the children,” Daybell replied in the exchange of messages. “I was shown last night how it fit together again.”

The children’s bodies were found in June 2020 and buried on property in Rexburg owned by Daybell. Horrific and heart-wrenching photos from the scene were shown to the jury early in the trial.

“Tylee’s DNA was found on a pickax and a shovel that were in the defendant’s garage,” Blake told the jury as she reviewed the evidence in her closing argument on Wednesday.

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Blake said Daybell used a numerical system to rate members of his and Vallow Daybell’s family, with higher numbers reserved for people whom he assessed as being overtaken by dark forces.

“Chad said if someone’s a zombie, the body has to die,” Blake told the jury.

Chad Daybell also was charged with two counts of insurance fraud. Prosecutors say he maxed out Tammy’s life insurance policy the month before she died, with himself as a beneficiary. Less than a month after Tammy’s death, he married Lori Vallow in Hawaii.

Couple was driven by odd beliefs, witnesses said

Chad Daybell and Lori Vallow Daybell were indicted together on the murder charges in May 2021; their cases were split at Daybell’s request.

Vallow Daybell was sentenced to multiple life terms in prison last year for the three deaths in Idaho.

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Melanie Gibb, a confidante of Vallow Daybell’s, testified last year that she saw her friend become increasingly involved with Chad Daybell, with the pair telling her that they had been married in a previous life. They spoke of being joined for eternity and leading 144,000 people in the end times, as described in the Book of Revelation, Gibb said.

Gibb said the couple also shared beliefs about people being overtaken by dark, evil energy. The criminal indictment cites text messages between the pair “regarding death percentages for Tammy” Daybell, as well as messages about her being in limbo, and Tammy “being possessed by a spirit named Viola.”

In addition to the charges in Idaho, Vallow Daybell has been extradited to Arizona to face chargesrelated to her former husband’s death in July 2019 and an attempt on the life of her niece’s ex-husband.

NPR’s Juliana Kim contributed reporting.

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