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EU approves first Covid jab for kids aged 5-11

AFP

The EU cleared Pfizer’s Covid-19 vaccine for use in children aged five to 11 on Thursday, the first jab to be approved in a cohort where the virus is rapidly spreading.

Only a small handful of countries had previously given the nod for coronavirus vaccinations in younger children, including the United States, Israel and Canada.

“I’m glad to tell you that Comirnaty from today has received approval for children five to 11 years of age,” said Marco Cavaleri, head of vaccine strategy at the European Medicines Agency (EMA), using the vaccine’s brand name.

“This is based on a different dose in the one used in adults, essentially it’s a much lower dose,” he told an online public meeting.

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The vaccine was already cleared for use in people aged 12 and over in the 27-nation EU.

Children aged five to 11 will be given one third of the dose that older people receive, with two injections, three weeks apart, the EMA said in a statement.

The vaccine was 90.7 percent effective in a study of nearly 2,000 children of that age, it added. 

Side effects were usually “mild or moderate” lasting a few days, and included pain in the injection site, tiredness, headache, muscle pain and chills.

The EMA “therefore concluded that the benefits of Comirnaty in children aged five to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19.”

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But the Pfizer jab’s safety in children “will continue to be monitored closely”.

– ‘Rare in children’ –

Health authorities say children make up an increasing proportion of new cases and hospitalisations in Europe, which is back at the centre of the coronavirus pandemic.

Children are also considered key drivers of infections even when they themselves do not come down with symptoms.

In the Netherlands, where the EMA is based, authorities said earlier this week that the largest increase in cases was among children up to the age of 12. 

“We know that severe Covid-19 and death remain quite rare in children, however disease of all severity occurs in all the paediatric ages,” Cavaleri said.

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“Moreover, high transmission results in increased hospitalisation in children of all ages.”

While children with underlying health conditions were more likely to become ill, the majority of children in hospital with Covid were otherwise healthy, said Cavaleri.

They were also at risk of so-called “long Covid” symptoms dragging on for months after infection, and multisystem inflammatory syndrome, he added. 

The EMA is separately reviewing Moderna’s coronavirus vaccine for children aged 6-11 and expects to reach a decision in January.

The regulator has so far approved four vaccines for use for adults in the EU: Pfizer and Moderna, which use messenger RNA technology, and AstraZeneca and Johnson & Johnson, which use viral vector technology.

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International

Suspect Armed With Shotgun and Knives Detained at White House Correspondents Dinner

U.S. authorities confirmed Saturday that the suspect who stormed into the White House Correspondents’ Association Dinner while President Donald Trump was attending acted alone, adding that there is no ongoing threat to the public following the incident, which left one Secret Service agent injured.

Acting Metropolitan Police Department chief Jeff Carroll said during a press conference that the suspect was carrying “a shotgun, a handgun, and multiple knives” when he attempted to pass through a Secret Service security checkpoint inside the hotel lobby at approximately 8:36 p.m. local time.

“At this point, everything indicates that this was a lone actor, a lone gunman,” Carroll stated, adding that investigators have found no preliminary evidence suggesting the involvement of additional suspects.

During the exchange of gunfire inside the hotel corridors, the suspect was not struck by bullets but was subdued by law enforcement officers and later transported to a hospital for medical evaluation.

A member of the United States Secret Service Uniformed Division was shot during the incident, though the bullet was stopped by the officer’s ballistic vest, preventing serious injuries. The agent was taken to a hospital and is reportedly “in good spirits,” according to Carroll.

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The shooting prompted the immediate evacuation of President Trump, Melania Trump, and several senior officials attending the event after multiple gunshots were heard outside the hotel’s main ballroom.

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International

U.S. allows Venezuela to fund Maduro and Cilia Flores’ legal defense

Until now, the U.S. administration had blocked the Venezuelan government from covering the legal fees of Nicolás Maduro and his wife, Cilia Flores, who is also jailed and facing drug trafficking charges, due to international sanctions imposed on Venezuela.

The couple’s legal team had relied on that argument in an attempt to have the indictment dismissed, claiming that preventing a defendant from accessing counsel of their choice violates rights guaranteed under the Sixth Amendment of the U.S. Constitution.

However, the U.S. Treasury Department will now allow “defense attorneys to receive payments from the Government of Venezuela under certain conditions,” New York prosecutor Jay Clayton wrote in a letter dated Friday to Judge Alvin Hellerstein, who is overseeing the case.

According to the letter, the funds must have become available after March 5, 2026, and cannot come from Venezuelan oil sales regulated in the United States.

Since Maduro’s removal from power in early January, former Vice President Delcy Rodríguez has served as Venezuela’s interim leader.

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The United States effectively controls Venezuelan crude exports, with revenues deposited into special accounts supervised by Washington.

Court documents filed on Friday show that the defense acknowledged the sanctions exemption and, for now, withdrew its motion seeking dismissal of the charges.

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International

U.S. Sanctions Network Linked to Fentanyl Trafficking Across India, Guatemala and Mexico

The United States Department of State announced sanctions on Thursday against 23 individuals and companies allegedly linked to an international fentanyl production and smuggling network operating in India, Guatemala and Mexico.

According to the State Department, the network supplied precursor chemicals to the Sinaloa Cartel, which the United States has designated as a Foreign Terrorist Organization.

Washington declared fentanyl, a powerful synthetic opioid, a weapon of mass destruction last year due to its role in the ongoing overdose crisis in the United States.

“By targeting the entire supply chain — from chemical suppliers in Asia to logistical intermediaries in Central America and cartel-linked networks in Mexico — the Trump Administration is dismantling networks that destabilize governance across our hemisphere and threaten U.S. security,” the State Department said.

In a separate statement, the Office of Foreign Assets Control detailed sanctions against three Indian chemical and pharmaceutical companies: Sutaria, Agrat and SR Chemicals, along with a sales executive accused of supplying precursor chemicals to contacts in Guatemala and Mexico.

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In Guatemala, authorities sanctioned J and C Import and Central Logística de Servicios, as well as intermediary Jaime Augusto Barrientos.

The OFAC also designated several intermediaries and import companies operating in the Mexican state of Sinaloa.

As part of the investigation, U.S. authorities identified Ramiro Baltazar Félix as a member of Los Mayos, a faction of the Sinaloa Cartel, and Alejandro Reynoso, accused of operating clandestine drug laboratories in Guadalajara.

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