White House and HHS are increasing pressure on FDA Commissioner Hahn to clear Pfizer and Moderna’s COVID-19 vaccines as soon as possible – potentially skirting the advisory committee process. The move is leaving a last-minute political stain on a regulatory process the FDA fought hard to keep science-based and could foster a new wave of vaccine hesitancy amongst the American public.

Two physicians experienced in agency affairs and operations, former commissioner David Kessler and former principal deputy commissioner Joshua Sharfstein, are reportedly finalists to head Biden’s FDA.

Operation Warp Speed will hold back initial shipments to ensure two-dose regimens can be completed; 15 December is ‘chalk’ target date for emergency authorization of Pfizer vaccine, OWS’ Gustave Perna says, calling it only a projection that does not impinge on FDA authority. Sending only half shipments also eases burden on cold shortage capacity at state and local level, he says.