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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

Erin brings strong winds and storm surge despite weakening offshore

Hurricane Erin weakened to a Category 2 storm on Tuesday but continues to pose a threat to parts of the U.S. East Coast with potentially dangerous flooding, according to meteorologists.

Although the hurricane’s eye is expected to remain offshore, experts are concerned about Erin’s size, as strong winds extend hundreds of kilometers beyond the storm’s center.

In its 18:00 GMT bulletin, the U.S. National Hurricane Center (NHC) lifted tropical storm warnings for the Bahamasand Turks and Caicos Islands, but kept them in effect for parts of North Carolina.

Erin was located several hundred kilometers southeast of North Carolina and was moving northwestward.

“This means there is a risk of potentially life-threatening flooding of 60 to 120 centimeters above ground level,” said NHC Director Michael Brennan.

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He also warned of the possibility of destructive waves, combined with storm surge, that could cause severe damage to beaches and coastal areas, making roads impassable.

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International

Three U.S. Warships deploy near Venezuela to combat drug trafficking

Three U.S. naval vessels are moving toward the coasts of Venezuela, according to international media reports on Tuesday, after White House spokesperson Karoline Leavitt confirmed that President Donald Trump is ready to combat and curb international drug trafficking.

Reports indicate that the ships will reach Venezuelan waters within the next 36 hours as part of a recent U.S. deployment aimed at countering international narcotics operations.

The announcement coincides with Leavitt’s statement that Trump is prepared to “use the full extent of his power” to halt drug flows into the United States. The naval deployment involves approximately 4,000 military personnel.

“The President has been clear and consistent. He is ready to use every element of U.S. power to prevent drugs from flooding our country and to bring those responsible to justice. The Maduro regime is not the legitimate government of Venezuela—it is a narco-terror cartel,” the spokesperson said during a press conference.

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International

Cuban authorities free salvadoran convicted in 1997 hotel bombing

Salvadoran national Otto René Rodríguez Llerena was released after serving a 30-year prison sentence for his involvement in a terrorist attack at a hotel in Cuba in 1997, the Cuban Ministry of Foreign Affairs reported.

During his trial, Rodríguez Llerena admitted to placing an explosive device at the Meliá Cohiba Hotel under the orders of anti-Castro exile leaders. He was arrested the following year when he returned to Havana with another load of explosives that failed to detonate.

“The Cuban government reiterates its commitment to combating terrorism, respecting human rights, and the need for the international community to hold accountable those who promote such acts,” the statement read.

He was released on August 15 and is the second Salvadoran to complete his sentence. In December of last year, another Salvadoran, Ernesto Cruz León, was released after planting bombs at tourist centers, one of which killed an Italian tourist identified as Fabio Di Celmo.

A third Salvadoran, Francisco Chávez Abarca, also received a 30-year sentence from Cuban courts in 2010 after being extradited from Venezuela through Interpol for actions against Cuba.

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Rodríguez Llerena had requested conditional release in 2016, arguing that his actions had not caused any direct fatalities, but no further information was released about his situation until now.

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