EU approves Pfizer shots for children aged 5 to 11 yr
New Delhi/IBNS: The European Union (EU) has cleared Pfizer's Covid-19 vaccine for children aged five to 11 on Thursday, the first shot to get approval for inoculating a population where the virus is spreading rapidly, media reports said.
"I'm glad to tell you that Comirnaty from today has received approval for children five to 11 years of age," said Marco Cavaleri, head of vaccine strategy at the European Medicines Agency (EMA), using the vaccine's brand name, reported AFP.
"This is based on a different dose in the one used in adults, essentially it's a much lower dose," he told an online public meeting.
More than 27 nations have already approved the use of the vaccine in adolescents aged 12 and over.
The children aged five to 11 will be given a reduced dose, equivalent to one-third of the dose that older people receive, with two injections, three weeks apart, the EMA said in a statement.
The vaccine showed 90.7 percent efficacy in nearly 2,000 children of that age, it added.
The EMA "therefore concluded that the benefits of Comirnaty in children aged five to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19."
Side effects like "mild or moderate" lasting a few days, and included pain in the injection site, tiredness, headache, muscle pain and chills.
The company said the vaccine's safety in children will continue to be monitored closely".
Health authorities say children make up an increasing proportion of new cases and hospitalisations in Europe, which is back at the centre of the coronavirus pandemic, the report said.