On October 12, 2021, the TGA, part of the Department of Health, granted a provisional determination to Pfizer Australia Pty Ltd in relation to its Covid-19 vaccine, Comirnaty.
Comirnaty is currently provisionally approved for use in individuals 12 years of age and older. The granting of this determination means Pfizer is now eligible to apply to vary the provisional approval for the vaccine to include children between the ages of 5 and 11.
This provisional determination is the first step in the process and does not mean that a request for variation has been submitted by the sponsor or that such variation will be provisionally approved by the TGA.
In making the decision to grant Pfizer an interim determination for use in individuals ages 5 to 11, the TGA considered eligibility criteria, including factors such as evidence of a plan to submit complete clinical data in relation to use in this age group – and the severity of the current Covid-19 pandemic.
[ https://www.theguardian.com/australia-news/live/2021/oct/13/australia-covid-news-new-south-wales-victoria-coalition-climate-cop26-environment-act-victoria-lockdown-vaccination-barnaby-morrison- https://d26toa8f6ahusa.cloudfront.net/wp-content/uploads/2021/07/30214746/a-quiet-place-part-2-bigs-16.pdf