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Friday, February 11, 2022

Pfizer, BioNTech to delay FDA request for vaccines for children under 5

 Pfizer and BioNTech on Friday said they are delaying their request for the Food and Drug Administration to authorize the vaccine for children under five years old, because there's not enough data on the efficacy of a third dose.

An FDA advisory panel meeting scheduled for next week has been postponed, the agency said.

"Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge," Pfizer said in a statement. 

https://thehill.com/policy/healthcare/593897-pfizer-biontech-to-delay-fda-request-for-vaccines-for-children-under-5

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