Positive topline results were announced from a phase 2/3 trial (ClinicalTrials.gov Identifier: NCT04816643) evaluating the efficacy, safety, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age.

Participants (n=2268) received a 2-dose regimen of 10mcg administered 21 days apart. “The 10mcg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer stated in a press release. Currently, the approved vaccine, Comirnaty, is only available as a 30mcg dose for individuals 12 years of age and older.

Results showed that the 10mcg dose level vaccine elicited strong neutralizing antibody responses, similar to those observed in individuals 16 to 25 years of age who received a 2-dose regimen of 30mcg (SARS-CoV-2 neutralizing antibody geometric mean titer: 1197.6 [95% CI, 1106.1-1296.6] vs 1146.5 [95% CI, 1045.5-1257.2], respectively). The vaccine safety profile was reported to be comparable to that observed in individuals 16 to 25 years of age.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the US – underscoring the public health need for vaccination,” said Albert Bourla, Chairman and CEO, Pfizer. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”


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Study results in children under 5 years of age are expected later this year. A 2-dose series of 3mcg each is being investigated for this age group.

Reference

Pfizer and BioNTech announce positive topline results from pivotal trial of COVID-19 vaccine in children 5 to 11 years. News release. Pfizer and BioNTech SE. Accessed September 20, 2021. https://www.businesswire.com/news/home/20210920005452/en/Pfizer-and-BioNTech-Announce-Positive-Topline-Results-From-Pivotal-Trial-of-COVID-19-Vaccine-in-Children-5-to-11-Years