TGA paves the way for under-fives COVID-19 vax
Pfizer has been given the green light to submit an application to extend use to the under-fives
The TGA has given approval for Pfizer to take the first step towards extending the use of its COVID-19 vaccine to children under five years of age.
The medical regulator has granted a provisional determination to Pfizer, which would allow the pharmaceutical company to apply to extend vaccine use to the younger cohort.
Pfizer’s mRNA vaccine Comirnaty is already approved for those aged five and over in Australia, but US regulators recently approved its use in younger children.
“The TGA considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data and the seriousness of the COVID-19 pandemic,” a TGA spokesperson said.
