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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

Five laboratories investigated in Spain over possible African Swine Fever leak

Catalan authorities announced this Saturday that a total of five laboratories are under investigation over a possible leak of the African swine fever virus, which is currently affecting Spain and has put Europe’s largest pork producer on alert.

“We have commissioned an audit of all facilities, of all centers within the 20-kilometer risk zone that are working with the African swine fever virus,” said Salvador Illa, president of the Catalonia regional government, during a press conference. Catalonia is the only Spanish region affected so far. “There are only a few centers, no more than five,” Illa added, one day after the first laboratory was announced as a potential source of the outbreak.

Illa also reported that the 80,000 pigs located on the 55 farms within the risk zone are healthy and “can be made available for human consumption following the established protocols.” Therefore, he said, “they may be safely marketed on the Spanish market.”

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International

María Corina Machado says Venezuela’s political transition “must take place”

Venezuelan opposition leader María Corina Machado said this Thursday, during a virtual appearance at an event hosted by the Venezuelan-American Association of the U.S. (VAAUS) in New York, that Venezuela’s political transition “must take place” and that the opposition is now “more organized than ever.”

Machado, who is set to receive the Nobel Peace Prize on December 10 in Oslo, Norway — although it is not yet known whether she will attend — stressed that the opposition is currently focused on defining “what comes next” to ensure that the transition is “orderly and effective.”

“We have legitimate leadership and a clear mandate from the people,” she said, adding that the international community supports this position.

Her remarks come amid a hardening of U.S. policy toward the government of Nicolás Maduro, with new economic sanctions and what has been described as the “full closure” of airspace over and around Venezuela — a measure aimed at airlines, pilots, and alleged traffickers — increasing pressure on Caracas and further complicating both air mobility and international commercial operations.

During her speech, Machado highlighted the resilience of the Venezuelan people, who “have suffered, but refuse to surrender,” and said the opposition is facing repression with “dignity and moral strength,” including “exiles and political prisoners who have been separated from their families and have given everything for the democratic cause.”

She also thanked U.S. President Donald Trump for recognizing that Venezuela’s transition is “a priority” and for his role as a “key figure in international pressure against the Maduro regime.”

“Is change coming? Absolutely yes,” Machado said, before concluding that “Venezuela will be free.”

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International

Catalonia’s president calls for greater ambition in defending democracy

The President of the Generalitat of Catalonia, Salvador Illa, on Thursday called for being “more ambitious” in defending democracy, which he warned is being threatened “from within” by inequality, extremism, and hate speech driven by what he described as a “politics of intimidation,” on the final day of his visit to Mexico.

“The greatest threat to democracies is born within themselves. It is inequality and the winds of extremism. Both need each other and feed off one another,” Illa said during a speech at the National Autonomous University of Mexico (UNAM) in Mexico City.

In his address, Illa stated that in the face of extremism, society can adopt “two attitudes: hope or fear,” and warned that hate-driven rhetoric seeks to weaken citizens’ resolve. “We must be aware that hate speech, the politics of intimidation, and threats in the form of tariffs, the persecution of migrants, drones flying over Europe, or even war like the invasion of Ukraine, or walls at the border, all pursue the same goal: to make citizens give up and renounce who they want to be,” he added.

Despite these challenges, he urged people “not to lose hope,” emphasizing that there is a “better alternative,” which he summarized as “dialogue, institutional cooperation, peace, and human values.”

“I sincerely believe that we must be more ambitious in our defense of democracy, and that we must remember, demonstrate, and put into practice everything we are capable of doing. Never before has humanity accumulated so much knowledge, so much capacity, and so much power to shape the future,” Illa stressed.

For that reason, he called for a daily defense of the democratic system “at all levels and by each person according to their responsibility,” warning that democracy is currently facing an “existential threat.”

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