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The biggest FDA approval of the third quarter was for a product that has already been used in more than 130 countries. August saw the full approval of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for those aged 16 and over, 8 months after it was initially granted emergency use authorization. Comirnaty has already become the fastest selling new product in pharma history — 2021 sales are forecast to exceed US$30 billion, and with booster programmes being rolled out, revenues will continue to accrue in 2022.