EU drug watchdog approves Pfizer Covid vaccine for children aged 5-11

By Amanda Morrow with RFI
Europe Frederic J. BROWN AFP/File
NOV 26, 2021 LISTEN
Frederic J. BROWN AFP/File

The EU's drug regulator approved the use of Pfizer-BioNTech's Cocid vaccine for use in children between the ages of 5 and 11 in a decision that comes as Europe struggling with a surge in infections.

The European Medicines Agency (EMA) has already recommended the vaccine for use in teenagers between 12 and 17 years old, to be given as two 10 microgram doses, three weeks apart. 

For children in the 5-11 age bracket, the agency said the lower two-dose regimen should also be given three weeks apart. Adult doses contain 30 micrograms.

Even with the smaller shot, children developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr Bill Gruber, a Pfizer senior vice president, told The Associated Press.

'Benefits outweigh risks'

After evaluating a study of the vaccine in more than 2,000 children, the EMA deemed the vaccine to be about 90 percent effective in preventing symptomatic Covid in young children.

"The benefits of in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19,” the EMA said.

Immunising young people is seen a critical step towards taming the pandemic. In Germany and the Netherlands, children now account for the majority of cases.

While final approval is up to the European Commission, it typically follows EMA recommendations and an EU source told Reuters that a decision would likely come on Friday.

(With wires)

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