BERLIN — BioNTech expects results by September from trials testing the COVID-19 vaccine that it and Pfizer have developed in babies as young as six months old, German magazine Spiegel cited the company’s CEO as saying.
“In July, the first results could be available for the five to 12 year olds, in September for the younger children,” BioNTech Chief Executive Ugur Sahin told Spiegel. He added it takes about four to six weeks to evaluate the data.
“If all goes well, as soon as the data is evaluated, we will be able to submit the application for approval of the vaccine for all children in the respective age group in different countries,” he said.
A spokeswoman for BioNTech confirmed the expected timeline for the trial results in younger children.
BioNTech and Pfizer asked U.S. regulators this month to approve emergency use of their vaccine for adolescents aged 12 to 15.
Sahin was quoted by Spiegel as saying the company was “in the final stages before submission” to European regulators for children aged 12 and older. The spokeswoman declined to comment on the timing of that submission, however.
A trial published at the end of March found the companies’ COVID-19 vaccine was safe, effective and produces robust antibody responses in adolescents.
The Pfizer/BioNTech two-shot vaccine is already authorized for use in those aged 16 and above.
Young people are less likely to suffer severe cases of COVID-19 and more likely to have asymptomatic infection, allowing them to unwittingly transmit COVID-19 to others.