FDA Begins Releasing Pfizer COVID Vax Documents

The FDA turned over thousands of documents related to its review of Pfizer-BioNTech’s COVID-19 vaccine last week, marking the first of several releases mandated by a court in Texas earlier this year.

The agency released 55,000 pages of COVID-19 vaccine review documents last Tuesday, following a loss in court months earlier that forced it to expedite its process to make the information available to the public. In a January court order, U.S. District Judge Mark Pittman of the Northern District of Texas required the FDA to release around 12,000 documents immediately, and then 55,000 pages a month until all documents are released — totaling more than 300,000 pages.

The nonprofit that won the case, Public Health and Medical Professionals for Transparency, sued the FDA last September, claiming that the agency denied its request to expedite the release of COVID-19 vaccine review documents via the Freedom of Information Act (FOIA). In a November joint status report, the FDA proposed releasing around 500 pages of the documents each month — which would fulfill the organization’s FOIA request in about 55 to 75 years.

The agency must redact confidential business and trade secret information from Pfizer and BioNTech, as well as any private information on patients in the clinical trial. In its proposal for a 55-year timeline, the FDA noted that the branch that would handle the request has only 10 employees, and is currently processing around 400 other FOIA requests.

Read Full Story
MedPage Today Rating

Share this:

Leave a Reply

%d bloggers like this: