On Sept. 6, 2021, Pfizer and BioNTech announced that they had 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 FDA and was to be filed with other regulatory authorities.