Pfizer and BioNTech have announced that their COVID-19 vaccine is safe for use in children aged five to 11 years old.
Results from a Phase II/III trial showed a favourable safety profile and ‘robust’ neutralising antibody response in children aged five- to 11-years-old using a two-dose vaccine regimen, administered 21 days apart. The study tested a smaller dose – 10 µg – in this study compared to the higher dose – 30µg – used for people aged 12 years and older.
According to the companies, the antibody responses in the participants given the smaller dose were comparable to those seen in a previous study in people aged 16- to 25-years-old who were immunised with 30µg doses.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.
“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose,” he added.
Pfizer and BioNTech are planning to submit the data to the US Food and Drug Administration, European Medicines Agency and other regulators ‘as soon as possible’.