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Pfizer And BioNTech To Amend Study Evaluating COVID-19 Vaccine in Children 6 months to Under 5 Years of Age

Published: 12/17/2021 13:53 GMT
BioNTech SE - ADR (BNTX) - Pfizer and Biontech Provide Update on Ongoing Studies of Covid-19 Vaccine.
Biontech Se - Co, Pfizer to Amend Clinical Study Evaluating Safety, Tolerability, Immunogenicity of Their Covid-19 Vaccine in Children 6 Months to Under 5 Years of Age.
Biontech Se - Study Will Now Include Evaluating a Third Dose of 3 Microgram at Least Two Months After the Second Dose.
Biontech - Initiated Low Dose Sub-study of a Third Dose of 10 Microgram Or 30 Microgram in About 600 Adolescents Aged 12- to 17.
Biontech Se - Changes Have Been Endorsed by and Agreed Upon With the U.S. Food and Drug Administration and the European Medicines Agency.
Biontech - If Three-dose Study is Successful, Sees Submitting Data to Regulators to Support Eua for Children 6 Months to Under 5 Yrs of Age in H1 2022.
Biontech Se - Also Plan to Evaluate a Third Dose of 10 Microgram Formulation in Children 5 to Under 12 Years of Age.
Biontech Se - a Pre-specified Immunogenicity Analysis Was Conducted on a Subset of the Study Population One Month Following the Second Dose.
Biontech Se - Compared to 16- to 25-year-old Population in Which High Efficacy Was Demonstrated, Non-inferiority Was Met for 6- to 24-month-old Population in the Analysis.
Biontech Se - Compared to 16- to 25-year-old Population in Which High Efficacy Was Demonstrated, Non-inferiority Was Not Met for 2- to Under 5-year-old Population.