Pfizer and its German partner said in a joint statement on Monday. “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 BioNTech CEO Dr Ugur Sahin. “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." The Pfizer-BioNTech combine plans to submit its data to regulatory bodies in the European Union, the United States and around the world “as soon as possible".
The trial results are the first of their kind for children under 12, with a Moderna trial for six-11 year olds still ongoing.