Pfizer/BioNTech have officially asked the FDA to authorize their vaccine for children aged 5-11.
According to the Wall Street Journal, the application could be processed in a matter of weeks — potentially teeing up an OK before November.
In September, the companies said that data from a late-stage study of the vaccine in the 5-11 age group showed that it was generally safe and generated as many antibodies as it did for people aged 16-25. However, the companies said that they are still working to determine the exact efficacy level for children aged 5-11 because not enough participants in the control group got sick to compare rates between the two cohorts.
Positive topline results released in March from the companies suggested that the vaccine was 100% effective in the 12-15-year-old adolescent group.
Researchers said that more information about the specific rate of efficacy for the 5-11 group will be determined as the study goes on. But because the trial met its endpoint for antibody generation, the companies feel ready to submit data to the FDA.
