Pfizer Announces Positive Topline Results of COVID-19 Vaccine in Children 5 to 11
Pfizer and BioNTech issued a press release suggesting that their Phase 2/3 trial in kids 5 to 11 years old showed a “favorable safety profile and robust neutralizing antibody response” in children 5 to 11 years of age. Their trial used a two-dose regimen of 10 µg administered 21 days apart (1/3 of the dose that’s in the adult vaccine).
Because their vaccine already demonstrated clinical effectiveness in the first trial, they did the study a little differently- focusing on the antibody titer that the vaccine stimulated (rather than comparing the number of persons that contracted COVID-19 in the vaccine and placebo groups).
They say that the antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age that got the 30 µg doses.
There were 2,268 participants 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.”
The company has submitted the data for peer review and will be asking FDA for EUA shortly. If they do submit the data quickly as promised, the FDA could make that EUA by mid-October, giving parents of elementary school kids an opportunity to vaccinate their progeny before Halloween.
