TGA, Australia's drug regulator, has issued a 2-year provisional approval for Tozinameran (BNT/Pfizer vaccine) from age 16, & released its 42-page assessment report tga.gov.au/auspar/auspar-… ...1/n
...One of the conditions is TGA approval of at least 20 vials from each batch before release...2/n
..Study of reproductive safety in rats has been completed & found no signs of concern related to pregnancy. This wasn't completed when the FDA reported. No data is in this report though. Otherwise it's the same data basis...3/n 
...Known & unknown safety risks judged within acceptable range. Identified anaphylaxis as a risk, & potential for vaccine-associated enhanced respiratory disease listed. Here's TGA's list of safety unknowns needing more clinical data...4/n
...Lists pharmacovigilance studies internationally. Incl safety/immunogenicity in 150 immunosuppressed people, flu vax co-administered, & people hospitalized with possible Covid-19. See EU: ema.europa.eu/en/documents/r… No Aust studies planned tho no data for Aust indigenous people. /5
• • •
Missing some Tweet in this thread? You can try to
force a refresh
