FDA authorised new mRNA formula for kids without a clinical trial

By Maryanne Demasi, PhD

In October 2021, Pfizer requested the permission of the US Food and Drug Administration (FDA) to amend the formulation of its covid-19 vaccine for children aged 5-11 yrs. 

Pfizer wanted to switch the “phosphate- buffered saline” used in previous adult formulations, to “tromethamine (Tris) buffer” and to exclude both sodium chloride…