that would explain why so many people have been confused about the approval.
in Australia, those who noted the name - Comirnaty - knew that it was on offer Down Under.
27 Aug: Australian Govt: Therapeutic Goods Association (TGA): COVID-19 vaccine: Pfizer Australia - COMIRNATY BNT162b2 (mRNA) - approved for use in individuals 12 years and older
On 22 July 2021 the Therapeutic Goods Administration (TGA) granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, in individuals aged 12 years and older.
This decision follows the provisional approval granted by the TGA to COMIRNATY on 25 January 2021 for used in individuals aged 16 years and older. Pfizer subsequently made an application to the TGA to vary the original approval to include children between 12 and 15 years of age...
Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment...
Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard...
The provisional approval pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data...
https://www.tga.gov.au/covid-19-vaccine-pfizer-australia-comirnaty-bnt162b2-mrna-approved-use-individuals-12-years-and-older
it’s shocking how many Australians believe the TGA independently assesses these vaccines, when they do nothing of the sort.
there is, at present, some concern building about the push to vaccinate 12-15 year olds.
meant to emphasise the following bit:
“Provisional approval of this vaccine is valid for two years”
for me, this “provisional” aspect should be mentioned by those in the media, especially, who push these vaccines 24/7. I would think “provisional” is different from “full approval”??