The evaluation of the Comirnaty vaccine was significantly expedited without compromising the TGA’s strict standards of safety, quality and efficacy. This was facilitated through rolling data submission, and through collaboration with international regulators. The provisional determination for the Pfizer-BioNTech COVID-19 vaccine, BNT162b2 (mRNA) was granted by TGA on 14 October 2020.
Facial paralysis: there were 4 reports of facial paralysis (Bell’s palsy) in the vaccine group with none in the placebo group.
42 pages.Australian Public Assessment Report
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