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The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.
Pfizer and BioNTech announced on Sept. 20, 2021 that topline data from their Phase II/III COVID-19 vaccine in children aged 5 to 11 demonstrated positive results. According to a Pfizer press release, the results demonstrated that the vaccine was safe, well-tolerated, and showed robust neutralizing antibody responses.
In the trial, participants were given a two-dose regimen of 10 µg administered 21 days apart. This is a smaller dose than the 30 µg dose used for people 12 and older, but was selected for this demographic because of concerns surrounding safety, tolerability, and immunogenicity.
The antibody responses were comparable to those in a previous study in people aged 16-25 who were immunized with 30 µg doses. The SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) in this trial was 1197.6 one month after the second dose. This was non-inferior to the GMT of 1146.5 from participants ages 16 to 25 years old, used as the control group for this analysis. Additionally, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 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, in the press release. “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.”