FDA grants full approval to Covid-19 vaccine developed by Pfizer, BioNTech

The Food and Drug Administration on Monday granted full approval to the Covid-19 vaccine developed by Pfizer and its partner BioNTech, a long-awaited development that public health officials hope will persuade some people who remain hesitant about the vaccine to get the shot.

The vaccine is the first of the pandemic vaccines used in the United States to transition from emergency use status to full licensure, a major victory for a partnership that decided to forgo funding through the government’s Operation Warp Speed program on the belief that the development project could move faster without being part of the government fast-tracking program.

The FDA said the vaccine was now approved for use in people ages 16 and up, the only group for which Pfizer now has the required six months of followup safety data. Study of the vaccine in 12- to 15-year-olds began later, and the six-month followup is still underway. Until it can be submitted to the FDA and an extension of the license can be issued, the vaccine will continue to be used in 12- to 15-year-olds under the emergency use authorization.

Pfizer and BioNTech are still conducting a clinical trial to support the vaccine’s use in children 11 and younger.