Pfizer and BioNTech Apply for FDA Emergency Use Authorization of Omicron Booster in Children

Pfizer and BioNTech have applied for emergency use authorization from the US Food and Drug Administration for their Omicron-targeted bivalent COVID-19 vaccine in children 4 and under (to 6 months). The application specifically is for the vaccine as a second booster, or fourth dose, as it is already approved for young children as a third dose.

According to Emily Kimber, “Pfizer and BioNTech also said that, in addition to their US application, they plan on making submissions to the European Medicines Agency and other regulatory authorities worldwide for use of the bivalent vaccine as a booster dose for children under five.”

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(Source: PM Live, March 2^nd, 2023)