EU regulator approves Pfizer’s COVID vaccine for children 5-11

HAAG, The Netherlands – The European Union’s Medicines Agency on Thursday approved Pfizer’s coronavirus vaccine for use in children aged 5 to 11, paving the way for shots fired at millions of primary school students amid a new wave of infections sweeping across the country. continent.

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

The agency said it “recommended providing an extension of the indication for the COVID-19 vaccine Comirnaty 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 that the vaccine was about 90% effective in preventing symptomatic COVID-19 in young children and said that the most common side effects were injection site pain, headache, muscle aches. pain and chills.

The agency said the two-dose regimen should be given to children three weeks apart.

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

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

Earlier this week, German Health Minister Jens Spahn said shipping of vaccines to younger children in the EU would begin on December 20.

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

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

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