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Moderna COVID-19 vaccine for children ages 5-11 being evaluated by EU drug regulator

Nov 10, 2021

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The European Union's drug regulator said Wednesday that it was evaluating whether to authorize Moderna's COVID-19 vaccine shot for children ages 5-11. 

The European Medicines Agency (EMA) is already evaluating the Pfizer-BioNTech vaccine for use in the same age group. 

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Amsterdam-based EMA said in a statement that it expects to make a recommendation about Moderna's vaccine in approximately two months, barring the need for more data and analysis.

In Europe, both the Moderna and Pfizer/BioNTech vaccines have been cleared for use in children ages 12-17. 

Moderna said in October that a low dose of its COVID-19 vaccine is safe and appears to be effective in 6-11 year-olds, though its vaccine is still pending emergency authorization for use in the U.S.

In this May 10, 2021 file photo, woman lights a candle to commemorate victims of the COVD-19 pandemic at the Prague Castle in Prague, Czech Republic. (AP Photo/Petr David Josek, file)

At the beginning of the month, the U.S. Centers for Disease Control and Prevention gave the OK for children ages 5-11 to receive kid-sized doses of the Pfizer/BioNTech vaccine, opening up eligibility to millions. 

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However, while COVID-19 cases in the U.S. have been declining as vaccinations continue, Europe has seen a surge in infections over the past six weeks. 

The number of cases recorded in the World Health Organization's (WHO) 61-country Europe region made up about two-thirds of the more than 3 million new infections reportedly globally in the past week.

The organization said Wednesday that coronavirus deaths rose by 10% there in the past week, while the number of weekly COVID-19 deaths fell by about 4% worldwide – declining in every region but Europe.

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Moderna Chairman Noubar Afeyan stresses that ‘boosting gives us the antibodies that are the first line of defense in our body to either preventing or counteracting the virus getting into the body.’

WHO’s Europe director, Dr. Hans Kluge, said last week that Europe was "back at the epicenter of the pandemic." 

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Kluge warned that if more actions were not taken to stop the spread of the virus, the region could see another 500,000 deaths by February.

The U.S., Russia, Britain, Turkey and Germany were the countries with the most new cases, according to the WHO. Ukraine also ranks within the top five, according to the Johns Hopkins Coronavirus Resource Center.

The Associated Press contributed to this report

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