Pfizer and BioNTech announced their results from a COVID-19 vaccine trial, which shows a “favourable safety profile” and robust immune response in children five to 11 years of age, according to a statement released on Monday. The trial included 2 268 participants.
The companies said they plan to ask for authorisation to use the vaccine in children in that age range in the US, Europe and elsewhere as soon as possible.
The participants were given “a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older”.
Chairman and Chief Executive Officer of Pfizer, Albert Bourla said: “We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.”
Pfizer and BioNTech also plans to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators, the statement read.
“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,” Dr. Ugur Sahin, CEO and co-founder of BioNTech said.