The FDA Really Did Have to Take This Long
After months of anticipation, Americans have a fully licensed COVID-19 vaccine. Today, the FDA announced the approval of Pfizer-BioNTech’s shot for people 16 and older—the first complete thumbs-up among the three vaccines available in the U.S.
The pervasive mood has been: Finally. Pfizer’s shot was given its emergency use authorization—the vaccine’s training wheels—back in December, and the company submitted its application for full approval in May. While America’s emergency-use vaccination rollout has saved an untold number of lives, many institutions, including some universities and hospitals, have been waiting for formal approval to mandate vaccinations. Health officials have expressed hope that approval will help persuade people who are vaccine-hesitant to get a shot.
Especially as COVID-19 cases skyrocket and hospitals strain under the Delta variant, the FDA has to stop “dragging its feet” on vaccine approvals, many people have argued. Lives are at stake. The urgency, the medical scientist Eric Topol recently wrote in The New York Times, “cannot be overstated.”
Except this hasn’t been the only mood. While the approval timeline for Pfizer has felt like forever to many, less than four months from application to full FDA approval is much faster than usual for a completely new type of drug—even a priority vaccine up to eight. The timeline has been so fast, in fact, that a group of scientists recently called for the agency to in the name of safety. “If the FDA listens to us, they won’t give serious consideration to approving a covid-19 vaccine until 2022,” the group .
