Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request From U.S. FDA

With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group to address the urgent public health need Companies plan to submit additional data on a third 3 µg dose in this age group in the coming months If authorization is granted, the Pfizer-BioNTech vaccine would be the first COVID-19 vaccine available for pediatric populations under 5 years of age Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that following a request from the U.S. Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to

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