and BioNTech SE said on Monday their COVID-19 vaccine induced a robust immune response in 5 to 11 year olds, and they plan to ask for regulatory authorization as soon as possible to use the shot in children in that age range in the United States, Europe and elsewhere.
"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," Bourla added. FDA acting Commissioner Janet Woodcock said that once the agency receives the application, its process for determining if the vaccine is safe and effective for children in the younger age group includes verifying the manufacturing processes for the lower concentrations of the shots and any study of its safety.
In addition, the companies said they expect data on how well the vaccine works in children ages 2-to-5 years and children ages 6 months-to-2 years as soon as the fourth quarter of this year. A Pfizer spokesperson said the companies may later disclose vaccine efficacy from the trial but there have not been enough cases of COVID-19 yet among the participants to make that determination.
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