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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

Brazil offers to mediate Colombia-Ecuador tensions, calls for restraint

The government of Brazil has offered to mediate in the ongoing tensions between Colombia and Ecuador, while calling on both nations to exercise restraint.

In a statement released Wednesday, Brazil’s Ministry of Foreign Affairs urged the parties involved to act with moderation and seek a peaceful resolution to the dispute.

“Brazil encourages all sides to act with moderation in order to find a peaceful solution to the controversy. It stands ready to support dialogue efforts aimed at preserving peace and security in the region,” the statement said.

Brazil also expressed “serious concern” over reports of deaths in the border area between Colombia and Ecuador, noting that the circumstances surrounding the incidents have not yet been clarified.

The diplomatic move comes amid rising tensions between the neighboring countries, increasing regional concern over stability and security along their shared border.

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International

U.S. lowers travel advisory for much of Venezuela but keeps high-risk zones under warning

The U.S. Department of State announced on Thursday that it has lowered its travel advisory for much of Venezuela to Level 3 (“Reconsider Travel”), reflecting what it described as improved security conditions in parts of the country.

However, the agency will maintain the highest Level 4 warning (“Do Not Travel”) for several regions, including the states of Táchira, Amazonas, Apure, Aragua and Guárico, as well as rural areas of Bolívar, citing ongoing risks such as crime, kidnapping and terrorism.

The updated advisory marks a shift from December, when the United States raised the alert for Venezuela to Level 4 nationwide, warning of severe security threats.

Despite the partial downgrade, U.S. authorities continue to urge caution, emphasizing that conditions remain volatile in certain areas and that travelers should carefully assess risks before planning any trips to the country.

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International

EU lawmakers move to ban AI tools that generate non-consensual nude images

Members of the European Parliament are pushing to ban across the bloc artificial intelligence services that allow users to digitally “undress” people without their consent.

The proposal, adopted on Wednesday at committee level, aims to prohibit applications that generate non-consensual explicit images. Irish lawmaker Michael McNamara, one of the sponsors, said the measure seeks to stop tools that “have caused significant harm for the benefit of a few.”

Dutch MEP Kim van Sparrentak welcomed the move, calling it “a major victory, especially for women and children in Europe.”

The amendment, part of broader EU legislation on artificial intelligence, was approved by the Parliament’s civil liberties and internal market committees. It specifically targets systems that use AI to create or manipulate sexually explicit or intimate images resembling identifiable individuals without their consent.

The proposal will be put to a full vote in the European Parliament on March 26. If adopted, lawmakers and European Union member states will need to agree on a final version before it can take effect.

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Separately, representatives of the 27 EU countries recently backed a Franco-Spanish amendment seeking to ban AI services used to generate non-consensual sexual images or child sexual abuse material.

The initiative follows controversy surrounding a feature introduced in Grok, developed by xAI, which allowed users to create simulated nude images from real photos. The tool sparked widespread criticism and prompted an EU investigation.

In response, xAI restricted image generation features in mid-January to paying subscribers and stated it blocks the creation of sexualized images in jurisdictions where such content is illegal.

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