Pfizer/BioNTech apply for full FDA approval of COVID-19 vaccine

WASHINGTON DC (WKZO AM/FM) – Pfizer and BioNTech have applied to the Food and Drug Administration for full approval for their coronavirus vaccine.

The FDA provided an Emergency Use Authorization for the two-shot vaccine in December of 2020, which granted the companies permission to distribute it under the provision that its benefits outweighed any risks.

Full approval would mean the FDA has full confidence in the vaccine, given additional data provided by Pfizer and BioNTech.

The companies are hoping to get FDA guidance next week on providing the vaccine to children 12 years old and up.