The US Food and Drug Administration (FDA) on Monday gave full approval to the Pfizer-BioNTech Covid-19 vaccine. It is the first Covid-19 vaccine to receive full approval, and will now be marketed as Comirnaty, the regulator said in a statement. It will be used for the prevention of Covid-19 disease in individuals 16 years of age and older. At the same time, the two-shot mRNA- based vaccine will continue to be available under emergency use authorisation (EUA), including for individuals 12 through 15 years of age.

It will also be used for the administration of a third dose in certain immunocompromised individuals, FDA said. "The FDA's approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic," Acting FDA Commissioner Janet Woodcock said in the statement. "While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorisation, as the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," she added.