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.
Although the court recognized the "unduly burdensome challenges" that this request imposed on the FDA, it concluded that the release of these documents is of "paramount public importance," stating that expediting the process is "not only practicable, but necessary." Both the FDA and the nonprofit will submit a joint status report by April 1 detailing the progress of the request.
After the FDA distributed the first batch of the documents last week, Public Health and Medical Professionals for Transparency posted the files on its own website. The content of the documents ranges widely, with no real explanation of what the files entail. One listed de-identified data on clinical trial patient demographics and medical history, while another detailed the FDA's response to Pfizer's request for fast track review. One included postmarketing safety data based on voluntarily reported adverse events.
Zach Zalewski, PhD, JD, a regulatory strategy consultant at Avalere Health, said that many of the documents that will be released were submitted to the FDA up through the vaccine's emergency use authorization and full approval, and may not be material to an overall analysis of the vaccine's safety and efficacy. The FDA already published a drug approval package for Pfizer-BioNTech's COVID-19 vaccine, which consists of summaries of the FDA-reviewed data. The documents that the agency is required to release will likely comprise the unabridged version of this report, Zalewski said.
"This will literally include every scrap of paper that was submitted to FDA for the entirety of the pandemic," Zalewski told MedPage Today. "If transparency is what they want, transparency is what they'll get."
Anti-vaccine advocates have already capitalized on the release of these documents to further call COVID-19 vaccines into question. Children's Health Defense, a nonprofit that has taken a stance against the use of COVID vaccines in kids, highlighted a list of adverse events reported in the documents -- a list that includes any adverse events that occurred in people who participated in the clinical trial, even those who received placebo, and is misleading, experts have said.
"There's a risk of cherry picking and taking things out of context," Zalewski said. "Just because you will have all the data in front of you, that doesn't mean you'll reach any different conclusions."
Public Health and Medical Professionals for Transparency includes several physicians known for spreading false or misleading information during the pandemic, including Aaron Kheriaty, MD, Harvey Risch, MD, PhD, and Peter McCullough, MD.