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Initial results from the trial indicate it was well-tolerated and promoted a good immune response.
A COVID-19 vaccine for children aged 5 to 11 years is 1 step closer to reality with the release of topline data from Pfizer/BioNTech for their vaccine, named COMIRNATY following the US Food and Drug Administration (FDA) approval of the vaccine for people aged 16 and older.1 The results from the Phase 2/3 trial showed the vaccine was safe, well tolerated, and promoted a robust response.
The trial had 2268 patients aged 5 to 11 years. They were given a 10 µg dose, which is smaller than the dose given to people aged 12 and old, in a 2-dose regimen. Following the second dose, the geometric mean titers taken showed strong immune responses a month after receiving both doses. The geometric mean titers also compared well to those seen in participants aged 16 to 25 years who had been used as the control group for the analysis. Overall, the side effects were comparable to those seen in the control group participants.
Pfizer/BioNTech plan to share these results with the FDA and other regulatory bodies around the world in the immediate future. Topline data from the 2 to 5 years of age and 6 months to 2 years of age cohorts are expected to be released at some point in the fourth quarter.
1. Pfizer. Pfizer and BioNTech announce positive topline results from pivotal trial of COVID-19 vaccine in children 5 to 11 years. Published September 20, 2021. Accessed September 20, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results