BRIEF—FDA slammed for 'Operation Turtle Speed' over COVID-19 vaccine approval

7 December 2020

In an op-ed for The Dispatch, Johns Hopkins Professor Marty Makary slammed the US Food and Drug Administration for "holding up COVID-19 vaccine approval" and dubbed the agency's progress "Operation Turtle Speed."

Pfizer submitted data detailing the safety and effectiveness of its BNT162b2 vaccine on November 22. But rather than immediately convening experts, the FDA scheduled a review meeting on December 10, almost three weeks later.

“As Pfizer’s application sits on the shelf at the FDA awaiting authorization, about 27,000 Americans will have died. So what is the FDA doing for three weeks? he asks

"As a Johns Hopkins scientist who has conducted more than 100 clinical studies and reviewed thousands more from the scientific community at large, I can assure you that the agency's review can be done within 24 to 48 hours without cutting any corners. They just need to work harder," Prof Makary argues.

A posting on the Seeking Alpha blog noted that Bahrain became the second country to grant emergency-use authorization to Pfizer and BioNTech's vaccine on Friday, while the UK became the first this past Wednesday.

Companies featured in this story

More ones to watch >