In an unexpect4ed move on Friday, Pfizer, one of three main vaccine makers has decided to pull their emergency use request for the vaccine on children younger than five years old.
Pfizer and BioNTech announced Friday that they are postponing their application to the Food and Drug Administration for the companies’ COVID-19 vaccine for children between the ages of six months and four years old.
The big picture: The companies said they “will wait for the three-dose data” because they “believe it may provide a higher level of protection in this age group.”
Data on a third dose is expected to become available in early April.
Details: “The trial in children 6 months through 4 years of age is ongoing and data on the first two … doses in this age group are being shared with the FDA on an ongoing basis,” Pfizer said in a statement.“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,” the company added.
“The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion.”