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Pfizer, BioNTech Seek COVID Biologic Emergency Use Authorization for Infants as Young as Six Months Old

by Natasha Hobley


Pfizer and BioNTech have requested emergency use authorization (EUA) for doctors to administer two doses of their mRNA COVID-19 biologic to infants as young as six months old. A statement from Pfizer states that the “rolling submission” application was submitted on Feb. 1, 2022 at the request of the U.S. Food and Drug Administration (FDA) “in response to the urgent public health need in this population.”1 Ten days later the company withdrew the request to gather more data on the vaccine’s effectiveness, which was suboptimal in two to four year olds, and provide evidence for a three dose primary series, rather than two doses.2


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