Pfizer and BioNTech say they have submitted relevant data to the US Food and Drug Administration for the highly anticipated authorization of their Covid-19 vaccine in children aged five to 11.
This comes as more children have been become infected in the latest wave driven by the Covid 19 Delta variant.
To keeping schools open, medical experts in the United States are advocating inoculating this age group to fight the deadly variant.
“These data have been shared with the FDA for the Agency’s initial review,” the companies said in a statement.
“A formal submission to request Emergency Use Authorization (EUA) of the companies Covid-19 vaccine in children 5 to <12 years of age is expected to follow in the coming weeks,” they added, with submissions to the European Medicines Agency and others also planned.
The news comes a week after the companies announced positive results from a global clinical trial showing the vaccines were safe and evoked a robust response of neutralizing antibodies, which stop the coronavirus from entering cells.
Children in the 5-11 age group received a two-dose regimen of 10 micrograms in the trial, compared with 30 micrograms for older age groups. The shots were given 21 days apart.