Pfizer and its partner BioNTech say their data support authorization of their COVID-19 vaccine in kids 5 to 11.
The Food and Drug Administration released the companies' briefing document this morning in a prelude to a meeting of expert advisers to the agency scheduled for Tuesday.
The companies studied a 10 microgram vaccine dose in children 5 to 11, a third of the dose used for adults and older children. The lower dose was chosen to minimize side effects and because it still prompts a strong immune response, the companies said.
In the main clinical trial conducted by the companies, the vaccine appeared to be more than 90% effective against symptomatic COVID-19
No new safety problems were identified in the companies' studies. No cases of heart inflammation were observed in the main study, but only a few thousand children were included in the research so that sort of rare problem wouldn't necessarily be detected.
The antibody response to the vaccine was comparable to the one seen in people 16 to 25 years old.
The FDA is preparing its own analysis, which is likely to be released later Friday.
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