Comirnaty® effective in children aged five to 11 years

Positive results from pivotal trial show that the COVID-19 vaccine Comirnaty is safe and effective in children aged five to 11 years old.

Child receiving vaccine

Pfizer and BioNTech have announced positive topline results from a Phase II/III trial showing a favourable safety profile and robust neutralising antibody responses for COVID-19 vaccine Comirnaty® in children five to 11 years old.  The vaccine was found to be safe, well tolerated and showed robust neutralising antibody responses.

The trial involved a two-dose regimen of 10µg administered 21 days apart, a smaller dose than the 30µg dose used for people 12 and older. The antibody responses in the participants given 10µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunised with 30µg doses. The 10µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children five to 11 years of age.

The data summarised from this Phase II/III study, which is enrolling children six months to 11 years of age, was for 2,268 participants who were five to 11 years of age and received a 10µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralising antibody geometric mean titer (GMT) was 1,197.6 (95 percent confidence interval [CI]), demonstrating strong immune response in this cohort of children one month after the second dose.

This was non-inferior to the GMT of 1146.5 (95 percent CI) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

“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,” commented Dr Ugur Sahin, Chief Executive Officer and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged five 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.”

Pfizer and BioNTech plan to share these data with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children two to five years of age and children six months to two years of age – are expected as soon as the fourth quarter of this year.