Zachary Stieber

U.S. drug regulators acknowledged deviating from the normal vaccine approval process when dealing with Pfizer’s COVID-19 shot, according to newly disclosed documents.

Weeks after Pfizer and its partner BioNTech announced they started a rolling submission of documents for approval of their COVID-19 vaccine, a U.S. Food and Drug Administration (FDA) official penned a memorandum authorizing the release of a Biologics License Application (BLA) number for the shot even as regulators weighed whether to approve the BLA, one of the documents shows.

… A separate document made public this week showed that the license number was given to Pfizer even though no approval decision had been made after Pfizer requested it.

… The FDA, which has never rejected an EUA or BLA request from Moderna or Pfizer related to their COVID-19 vaccines, and the Centers for Disease Control and Prevention, made a trend of bypassing the advisory panels during the pandemic, including when they authorized and recommended boosters in the fall of 2022 without any clinical data.