Pfizer: data submitted for Covid vaccine in children
(CercleFinance.com) - Following the announcement of positive study results on 20 September, Pfizer and BioNTech report that they have submitted data to the US FDA from the Phase 2/3 trial of their Covid-19 vaccine in children aged five to 12 years old.
In the trial, which included 2,268 participants in this age group, the vaccine demonstrated a favourable safety profile and elicited robust neutralising antibody responses using a two-dose regimen of 10 μg.
A formal application for emergency use of the vaccine in this age group is expected to follow in the coming weeks. Applications to the European Medicines Agency and other regulatory authorities are also planned.
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In the trial, which included 2,268 participants in this age group, the vaccine demonstrated a favourable safety profile and elicited robust neutralising antibody responses using a two-dose regimen of 10 μg.
A formal application for emergency use of the vaccine in this age group is expected to follow in the coming weeks. Applications to the European Medicines Agency and other regulatory authorities are also planned.
Copyright (c) 2021 CercleFinance.com. All rights reserved.