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European Union regulator approves Pfizer vaccine for five-year-olds

THE HAGUE, Netherlands (AP) – The European Union’s medicines regulator on Thursday cleared Pfizer’s coronavirus vaccine for children aged 5 to 11, paving the way for administration of vaccines to millions of elementary school students amid a new wave of infections sweeping the continent.

This is the first time that the European Medicines Agency has authorized a vaccine against COVID-19 for use in young children.

The agency said it “recommends granting an indication extension for the COVID-19 Comirnaty vaccine to include use in children aged 5 to 11.”

After evaluating a study of the vaccine in more than 2,000 children, the EMA estimated the vaccine to be around 90% effective in preventing symptomatic COVID-19 in young children and said the most common side effects were pain at the injection site, headache, muscle pain and chills. The agency said the two-dose regimen should be given to children three weeks apart.

At least one country facing spikes in infections did not wait for EMA approval. Authorities in the Austrian capital, Vienna, have already started vaccinating the 5-11 year old age group. Europe is currently at the epicenter of the pandemic and the World Health Organization has warned the continent could see the death toll exceed 2 million by spring, unless urgent action is taken .

The EMA’s green light for the vaccine developed by Pfizer and German company BioNTech must be approved by the EU’s executive branch, the European Commission, before health authorities in member states can start administering vaccines.

Earlier this week, German Health Minister Jens Spahn said the shipment of vaccines for young children to the EU would begin on December 20.

The United States approved Pfizer’s children’s photos earlier this month, followed by other countries including Canada.

Pfizer has tested a dose that is one-third of the amount given to adults for children of elementary school age. Even with the smallest injection, children aged 5 to 11 developed levels of anti-coronavirus antibodies just as strong as teens and young adults receiving the regular-strength injections, the Associated Press told the Dr Bill Gruber, senior vice president of Pfizer. in September.

But studies of Pfizer’s vaccine in children were not large enough to detect rare side effects from the second dose, such as chest and heart inflammation seen in most older adolescents and young people. adults.

U.S. officials noted that COVID-19 caused more deaths in children ages 5 to 11 than some other diseases, such as chickenpox, before children were routinely immunized.

Earlier this month, the EMA said it had started evaluating the use of Moderna Inc.’s COVID-19 vaccine for children aged 6 to 11; he estimated that a decision would be made within two months.

Although most children only show mild symptoms of COVID-19, some public health experts believe their immunization should be a priority to reduce the continued spread of the virus, which could theoretically lead to the emergence of a dangerous new variant.

Researchers disagree on the influence of children on the course of the pandemic. Early research suggested they had not contributed much to the viral spread. But some experts say children have played a significant role this year in the spread of contagious variants such as alpha and delta.

In a statement released this week, the WHO said that because children and adolescents tend to have milder COVID-19 disease than adults, “there is less urgency to vaccinate them than the elderly, the chronically ill people and health workers “.

He called on rich countries to stop immunizing children and asked them to donate their doses immediately to poor countries that have yet to administer a first dose of vaccine to their health workers and vulnerable populations.

Yet the WHO has recognized that immunizing children and adolescents has benefits that go beyond the immediate health benefits.

“Vaccination that decreases transmission of COVID in this age group can reduce transmission from children and adolescents to the elderly and may help reduce the need for mitigation measures in schools,” the WHO said.

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