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Pfizer submits data for COVID vaccine in younger children

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eMediNexus    29 September 2021

Pfizer Inc and BioNTech SE have submitted preliminary trial data for their COVID-19 vaccine in children aged between 5 and 11 years and intend to seek emergency use authorization from the U.S. regulators in the coming weeks.

The U.S. Food and Drug Administration had stated earlier that it would look to finalize the data review for this age group soon, possibly in a few weeks rather than months. This could indicate that an authorization for the vaccine in children may be received by the end of October.

The vaccine is already authorized for use in the 12-15years age group and is fully approved for those aged 16 and above. The vaccine was shown to induce a strong immune response in the 5-11-year-olds in a trial with 2,268participants, the companies had reported on September 20… (Reuters, September 29, 2021)

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