Pfizer and BioNTech file for Comirnaty booster jab appro with EMA

6 September 2021

US pharma giant Pfizer (NYSE: PFE) and German partner BioNTech (Nasdaq: BNTX) today announced that they have submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of Comirnaty (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.

The same data had been submitted to the US Food and Drug Administration and will be filed with other regulatory authorities in the upcoming weeks.

The submitted variation includes data from a Phase III clinical trial of 306 participants 18-55 years of age who received a booster (third) dose of Comirnaty, between 4.8 and 8 months after completing the two-dose primary regimen, with a median follow-up time of 2.6 months post-booster.

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