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Tuesday, May 11, 2021

Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine in adolescents

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.

By: Reuters |
April 10, 2021 10:16:59 am
Pfizer vaccine, COVID-19 vaccineIn a study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given dummy shots, Pfizer reported.

Pfizer Inc and its German partner BioNTech SE said on Friday they have requested the US 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.

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