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

The EU's drug regulator  has approved this week 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 struggles with a surge in infections.

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. Frederic J. BROWN AFP/File

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.

‼️ EMA recommends approval of BioNTech/Pfizer’s #COVID19vaccine, Comirnaty, for children aged 5 to 11.

In this population, the dose of #Comirnaty will be lower than that used in people aged 12 and above.

Read the full press release: https://t.co/uqqBAklVvl pic.twitter.com/NZQhli4SDl

— EU Medicines Agency (@EMA_News) November 25, 2021

'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.

• Rampant Covid cases in Europe provoke dire warning from WHO

Immunising young people is seen as 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)