Why Was Pfizer Allowed to Skip a COVID Vaccine Study?

Calley Means says continued approval of Pfizer's COVID vaccine was conditioned on a new study and that the FDA subsequently removed the requirement. He credits Marty Makary and Vinay Prasad with seeking the study and describes its cancellation as a lost opportunity to obtain evidence.

He distinguishes his account of the requirement from his inference about how it was dropped. When Joe Rogan asks how the reversal happened, Means says he has no personal insight, then argues that such a change would require direction from above. He also speculates that Pfizer did not want the results released. Neither inference is presented here as a documented instruction or proof of what the study would have found. Means describes Kennedy as asking for studies rather than dictating their outcome.