Because they were insufficiently safety tested.
Please head to the TGA’s Delegate’s Overview and Request for ACV’s Advice from January 11, 2022 regarding the p-fizer/comirnaty product. It took place at The 18th ACV meeting on 15 January 2021.
The clinical data to support this provisional registration are largely from Study C4591001, an ongoing Phase 1/2/3,Page 4 of 53 randomized, observer-blind, placebo-controlled study to assess immunogenicity, efficacy and safety of BNT162b2 [mRNA] vaccine.
This study involved 16 year olds and older, 38,000 individuals with 2 months follow-up with claimed mild or moderate reactogenicity, low incidence of serious adverse events, and no clinically significant safety concerns. Remember that.
Limitations of the current data include: 1. Safety follow up is currently limited to median two months post Dose 2 2. The duration of immune response and vaccine protection is not currently known 3. Vaccine efficacy against asymptomatic infection and viral transmission are not yet known 4. The data in immunocompromised individuals are very limited 5. Lack of data in paediatric subjects, pregnant women, and lactating mothers
It is important to mention that they simply ‘proposed’ that these ‘limitations’ should be addressed.
I also find it interesting that the box in the following screenshot from page 4 is not checked. Doesn’t that mean, that there was a reason to say, at that time, that the application for Comirnaty should not be approved for provisional registration?