The Phase 2/3 trial used a two-dose regimen of 10 µg (in contrast to the 30 µg used in individuals 12+) administered 21 days apart. The antibody responses in the participants given 10 µg doses were comparable to in people 16 to 25 years of age with 30 µg doses.
Pfizer CEO Albert Bourla says it will submit the results to the US FDA as soon as possible, as well as to other regulators around the globe, with a view of extending authorization for the vaccine to this age group.
“Since July, pediatric cases of COVID-19 have risen by about 240% in the US – underscoring the public health need for vaccination,” he said.
The data comes from 2,268 participants aged 5 to 11 years old. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose.
This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) 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 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.
Topline readouts for the other two age cohorts from the trial – children aged 2-5 years and younger children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year.