Pfizer jab approved for 12 year olds and above: Based on what evidence?

On 22 July 2021, the Therapeutic Goods Administration (Australia) granted provisional approval for the Covid Pfizer vaccine, COMIRNATY, to be used in children as young as 12 years old.

Firstly, it essential to point out that all Covid vaccines in Australia only have 'provisional' approval, not full approval. See: TGA Provisional registrations.

As for the available safety evidence, let's take a closer look at the official Product Information from Pfizer:

“In an analysis of Study C4591001, based on data up to the cutoff date of 13 March 2021, 2,260 adolescents (1,131 COMIRNATY; 1,129 placebo) were 12 to 15 years of age. Of these, 1,308 adolescents (660 COMIRNATY and 648 placebo) have been followed for at least 2 months after the second dose of COMIRNATY. The safety evaluation in Study C4591001 is ongoing.” (Sect. 4.8, p. 9)

It is rather astonishing that a government would give any kind of approval for a vaccine to be administered to 12-15 year olds, on the basis of such a tiny data set. Moreover, parents may be shocked to learn that the safety evaluation “is ongoing” (i.e. safety has not been properly established).