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Tuesday, December 7, 2021

Pfizer/BioNTech asks EMA to authorise vaccine for 5 to 11-year-olds

Pfizer/BioNTech has requested that the European Medicines Agency (EMA) approve its vaccine for use in those aged 5 to 11 years old.

This follows a similar step that was taken in the United States after the pharmaceutical company announced last month that trial results had shown the jab was safe for the age cohort.


Data was submitted to the EMA in relation to the vaccine, which includes results from an ongoing clinical study.

Pfizer/BioNTech stated that the data is from a study that involved 2,268 children aged five to 11 years old and that it has been sent to the EMA with a view to securing “Conditional Marketing Authorisation in the European Union”.

Chair of Ireland’s Covid-19 taskforce Professor Brian MacCraith described the study as a “significant development”.


The pharmaceutical company revealed that “The same data have been submitted to the US Food and Drug Administration and will be filed with other regulatory authorities in the coming weeks.”

A meeting has been scheduled for the 26th of October with the US Food and Drug Administration to review the data before making a decision on the vaccine’s authorisation in the age cohort.

Pfizer/BioNTech is also trialling its vaccine on infants aged six months to two years old, and on children aged two to five.

The data for these two age cohorts could be released by the end of the year.

IMAGE – “201214-D-BN624-0811” (CC BY 2.0) by U.S. Secretary of Defense


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