Explained: What FDA full approval to Pfizer-BioNTech vaccine means

The research to develop a safe and effective Covid-19 vaccine was accelerated in 2020

The US Food and Drug Admin­istration (USFDA) has given full approval to the Pfizer-BioNTech Covid-19 vaccine for people aged 16 and above. The vaccine, which will now be marketed as Comirnaty, continues to be avai­l­able under emergency use aut­h­orisation (EUA), including for individuals aged 12 to 15 and for administering a third dose to certain immunocompromised individuals. Let’s find out what chan­ges with this marketing approval.

How are EUA and full mark­et­ing authorisation different?

EUA is when in an emergency a regulator gives marketing authorisation to an unapproved medical product or unapproved uses of an approved medical product to diagnose,