Moderna Says Infant Covid Vaccine Succeeded in Trial

Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators for its Covid vaccine in children aged six months to six years Joseph Prezioso AFP/File
Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators for its Covid vaccine in children aged six months to six years Joseph Prezioso AFP/File
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Moderna Says Infant Covid Vaccine Succeeded in Trial

Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators for its Covid vaccine in children aged six months to six years Joseph Prezioso AFP/File
Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators for its Covid vaccine in children aged six months to six years Joseph Prezioso AFP/File

US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its Covid vaccine in children under six years old after the two-shot regimen was found to be safe and produced a strong immune response.

Specifically, two doses of 25 micrograms given to babies, toddlers and preschoolers generated similar levels of antibodies to two doses of 100 micrograms given to young people aged 18-25, indicating there would be similar levels of protection, AFP said.

Children under six are the only age group that has yet to gain access to a Covid-19 vaccine in the United States.

Based on the data, Moderna said it would submit authorization requests to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the coming weeks.

The results "are good news for parents of children under six years of age," said CEO Stephane Bancel in a statement.

"We now have clinical data on the performance of our vaccine from infants six months of age through older adults."

The company did however find relatively low vaccine efficacy against infection, with its trial taking place during the Omicron wave.

Vaccine efficacy in children six months up to age two was 43.7 percent, and efficacy was 37.5 percent in the two to five years age group.

The majority of these cases were mild and the two doses still provided very strong protection against severe outcomes. There were no hospitalizations or deaths.

Moderna said this was consistent with what had been observed among adults, and the company was evaluating a third dose as a booster, to increase efficacy against Omicron infection.

The trial included 4,200 aged two to six years and 2,500 aged six months to two years.

Side effects were generally mild and consistent with those seen in older age groups.

Rates of fever greater than 38 degrees Celsius (100.4 Fahrenheit) were around the same as commonly used and recommended pediatric vaccines: 17 percent in the six months to two years group, and 15 percent in the two years to six years group.

The company added that, after consulting with the FDA, it is also applying to be authorized among children six to 11 for two doses of 50 micrograms, and updating its application for authorization in kids aged 12 through 17.

The EMA and other regulators have already authorized the Moderna vaccine in these age groups.

Last month, the FDA postponed a meeting of a panel to consider the Pfizer-BioNTech Covid vaccine for children younger than five, saying it required additional data on third doses. The companies said they expected that data to be ready by April.



FBI Says Trump Was Indeed Struck by Bullet during Assassination Attempt

Republican presidential nominee and former US President Donald Trump speaks at Turning Point Action's The Believers Summit 2024 in West Palm Beach, Florida, US, July 26, 2024. (Reuters)
Republican presidential nominee and former US President Donald Trump speaks at Turning Point Action's The Believers Summit 2024 in West Palm Beach, Florida, US, July 26, 2024. (Reuters)
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FBI Says Trump Was Indeed Struck by Bullet during Assassination Attempt

Republican presidential nominee and former US President Donald Trump speaks at Turning Point Action's The Believers Summit 2024 in West Palm Beach, Florida, US, July 26, 2024. (Reuters)
Republican presidential nominee and former US President Donald Trump speaks at Turning Point Action's The Believers Summit 2024 in West Palm Beach, Florida, US, July 26, 2024. (Reuters)

Nearly two weeks after Donald Trump’s near assassination, the FBI confirmed Friday that it was indeed a bullet that struck the former president’s ear, moving to clear up conflicting accounts about what caused the former president’s injuries after a gunman opened fire at a Pennsylvania rally.

"What struck former President Trump in the ear was a bullet, whether whole or fragmented into smaller pieces, fired from the deceased subject’s rifle," the agency said in a statement.

The one-sentence statement from the FBI marked the most definitive law enforcement account of Trump’s injuries and followed ambiguous comments earlier in the week from Director Christopher Wray that appeared to cast doubt on whether Trump had actually been hit by a bullet.

The comment drew fury from Trump and his allies and further stoked conspiracy theories that have flourished on both sides of the political aisle amid a dearth of information following the July 13 attack.

Up until now, federal law enforcement agents involved in the investigation, including the FBI and Secret Service, had refused to provide information about what caused Trump’s injuries. Trump’s campaign has also declined to release medical records from the hospital where he was first treated or to make the doctors there available for questions.

Updates have instead come either from Trump himself or from Trump’s former White House doctor, Ronny Jackson, a staunch ally who now represents Texas in Congress. Though Jackson has been treating Trump since the night of the attack, he has come under considerable scrutiny and is not Trump’s primary care physician.

The FBI’s apparent reluctance to immediately vouch for the former president’s version of events has also raised fresh tension between the Republican nominee and the nation’s premier federal law enforcement agency, which he could soon exert control over once again. Trump and his supporters have for years accused federal law enforcement of being weaponized against him, something Wray has consistently denied.

Speaking at an event later Friday in West Palm Beach Florida, Trump drew boos from the crowd when he described the suggestion that he may have been struck by glass or shrapnel instead of a bullet.

"Did you see the FBI today apologized?" he asked. "It just never ends with these people. ... We accept their apology."

Trump appeared Friday for the first time without a bandage on his right ear. Photographs and video showed no sign of continued bleeding, and no distinct holes or gashes.

Questions about the extent and nature of Trump’s wound began immediately after the attack, as his campaign and law enforcement officials declined to answer questions about his condition or the treatment he received after Trump narrowly escaped death in an attempted assassination by a gunman with a high-powered rifle.

Those questions have persisted despite photographs showing the trace of a projectile speeding past Trump’s head as well as Trump’s teleprompter glass intact after the shooting, and the account Trump himself gave in a Truth Social post within hours of the shooting that he had been "shot with a bullet that pierced the upper part of my right ear."

"I knew immediately that something was wrong in that I heard a whizzing sound, shots, and immediately felt the bullet ripping through the skin," he wrote.

Days later, in a speech accepting the nomination at the Republican National Convention in Milwaukee, Trump recounted the scene in detail, while wearing a large gauze bandage over his right ear.

"I heard a loud whizzing sound and felt something hit me really, really hard, on my right ear. I said to myself, ‘Wow, what was that? It can only be a bullet,’" he said.

"If I had not moved my head at that very last instant," Trump said, "the assassin’s bullet would have perfectly hit its mark, and I would not be here tonight."

But the first medical account of Trump’s condition didn’t come until a full week after the shooting, when Jackson released his first letter last Saturday evening. In it, he said the bullet that struck Trump had "produced a 2 cm wide wound that extended down to the cartilaginous surface of the ear." He also revealed Trump had received a CT scan at the hospital.

Federal law enforcement involved in the investigation, including the FBI and Secret Service, had declined to confirm that account. And Wray’s testimony offered apparently conflicting answers on the issue.

"There’s some question about whether or not it’s a bullet or shrapnel that hit his ear," Wray said, before he seemed to suggest it was indeed a bullet.

"I don’t know whether that bullet, in addition to causing the grazing, could have also landed somewhere else," he said.

On Thursday, the FBI sought to clarify matters with a statement affirming that the shooting was an "attempted assassination of former President Trump which resulted in his injury, as well as the death of a heroic father and the injuries of several other victims." The FBI also said Thursday that its Shooting Reconstruction Team continues to examine bullet fragments and other evidence from the scene.

Jackson, who has been treating the former president since the night of the July 13 shooting, told The Associated Press on Thursday that any suggestion Trump’s ear was bloodied by anything other than a bullet was reckless.

"It was a bullet wound," said Jackson. "You can’t make statements like that. It leads to all these conspiracy theories."

In his letter Friday, Jackson insisted "there is absolutely no evidence" Trump was struck by anything other than a bullet and said it was "wrong and inappropriate to suggest anything else."

He wrote that at Butler Memorial Hospital, where the GOP nominee was rushed after the shooting, he was evaluated and treated for a "Gunshot Wound to the Right Ear."

"Having served as an Emergency Medicine physician for over 20 years in the United States Navy, including as a combat physician on the battlefield in Iraq," he wrote, "I have treated many gunshot wounds in my career. Based on my direct observations of the injury, my relevant clinical background, and my significant experience evaluating and treating patients with similar wounds, I completely concur with the initial assessment and treatment provided by the doctors at nurses at Butler Memorial Hospital on the day of the shooting."

The FBI declined to comment on the Jackson letters.

Asked if the campaign would release those hospital records, or allow the doctors who treated him there to speak, Trump campaign spokesperson Steven Cheung blasted the media for asking.

"The media has no shame in engaging in disgusting conspiracy theories," he said. "The facts are the facts, and to question an abhorrent assassination attempt that ultimately cost a life and injured two others is beyond the pale."

In emails last week, he told the AP that "medical readouts" had already been provided.

"It’s sad some people still don’t believe a shooting happened," Cheung said, "even after one person was killed and others were injured."

Anyone who believes the conspiracies, he added, "is either mentally deficient or willfully peddling falsehoods for political reasons."

Sen. Lindsey Graham, R-S.C., a close Trump ally, also urged Wray to correct his testimony in a letter Friday, saying the fact Trump had been hit by a bullet "was made clear in briefings my office received and should not be a point of contention."

"As head of the FBI, you should not be creating confusion about such matters, as it further undercuts the agency’s credibility with millions of Americans," he wrote.

Trump also lashed out at Wray in a post on his Truth Social network, saying it was "No wonder the once storied FBI has lost the confidence of America!"

"No, it was, unfortunately, a bullet that hit my ear, and hit it hard. There was no glass, there was no shrapnel," he wrote.

On Friday, he called Wray’s comments "so damaging to the Great People that work in the FBI."

Jackson has encountered significant scrutiny over the years.

After administering a physical to Trump in 2018, he drew headlines for suggesting that "if he had a healthier diet over the last 20 years, he might live to be 200 years old."

He was reportedly demoted by the Navy after the Department of Defense inspector general released a scathing report on his conduct as a top White House physician that found Jackson had made "sexual and denigrating" comments about a female subordinates and took prescription-strength sleeping medication that prompted worries from his colleagues about his ability to provide proper medical care.

Trump appointed Wray as FBI director in 2017 to replace the fired James Comey. But the then-president swiftly soured on his hire as the bureau continued its investigation into the Russian election interference.

Trump flirted openly with the idea of firing Wray as his term drew to a close, and he lashed out anew after the FBI executed a search warrant at his Mar-a-Lago estate in Florida to recover boxes of classified documents from his presidency.