Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11.
The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA.
The companies last week announced that the vaccine had favorable immunogenicity and tolerability in children 5 to 11.
Vaccine recipients in the clinical trial received a 10-μg dose of mRNA, which is one-third of the amount the company had studied in 16 to 25 year-olds.
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