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April 9 (Reuters) - Pfizer Inc and its German partner BioNTech SE said on Friday they have requested the U.S. Food and Drug Administration to expand the emergency use of their COVID-19 vaccine in adolescents aged 12 to 15.
In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.
Whether COVID-19 vaccines work and are safe to use on children is one of the big questions drugmakers are trying to answer. Inoculating children and young people is considered a critical step toward reaching "herd immunity" and taming the pandemic, according to experts.
The companies plan to request similar rulings by other regulatory authorities globally in the coming days.
The Pfizer/BioNTech two-shot vaccine is already authorized for use in people as young as 16.
(Reporting by Mrinalika Roy in Bengaluru; Editing by
Ramakrishnan M.)
((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;)
April 9 (Reuters) - Pfizer Inc and its German partner BioNTech SE said on Friday they have requested the U.S. Food and Drug Administration to expand the emergency use of their COVID-19 vaccine in adolescents aged 12 to 15.
In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.
Whether COVID-19 vaccines work and are safe to use on children is one of the big questions drugmakers are trying to answer. Inoculating children and young people is considered a critical step toward reaching "herd immunity" and taming the pandemic, according to experts.
The companies plan to request similar rulings by other regulatory authorities globally in the coming days.
The Pfizer/BioNTech two-shot vaccine is already authorized for use in people as young as 16.
(Reporting by Mrinalika Roy in Bengaluru; Editing by
Ramakrishnan M.)
((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;)