Pfizer and BioNTech said on Friday they had submitted data to the European Union’s drugs watchdog for approval of their coronavirus vaccine for children aged 5 to 11, following a similar move in the United States.
Vaccine makers announced last month that test results showed their jab was safe and caused a “strong” immune response in that age group.
US pharma giant Pfizer and German partner BioNTech said they had submitted data from their study involving 2,268 children aged five to 11 years with the aim of securing “conditional marketing authorization in the European Union” to the European Medicines Agency (EMA).
“The same data has been submitted to the US Food and Drug Administration and will be filed with other regulatory authorities in the coming weeks,” he said.
Although children are thought to be at low risk from severe COVID-19, they can still become ill and transmit the virus to the wider population.
Vaccinating young children is seen as a key to keeping schools open and helping to end the pandemic.
Pfizer and BioNTech formally requested emergency use authorization for their vaccines in 5-11-year-olds in the US last week.
The FDA has scheduled an October 26 meeting to review the data, before giving its opinion on whether authorization should be granted.
Children ages 5-11 in the Pfizer trial received a two-dose dose of 10 micrograms, compared to 30 micrograms for the older age groups. The shots were given 21 days apart.
The Pfizer vaccine is already being offered to adolescents over the age of 12 in several countries, as well as adults around the world.
Pfizer and BioNTech are also testing their vaccines on infants between the ages of six months and two years and children between the ages of two and five.
Preliminary figures for these groups could come before the end of the year.
Israel has already given special authorization to vaccinate children aged 5-11 years “at significant risk of serious illness or death” from COVID, using the Pfizer jab at low doses.
The Pfizer vaccine is based on the same novel mRNA technology as its US rival Moderna.
Moderna’s trial on children aged 6 to 11 is still going on.
(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)