FDA Begins Releasing Pfizer COVID Vax Documents

— Court-ordered release runs risk of "cherry picking and taking things out of context"

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 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.

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.

"This will literally include every scrap of paper that was submitted to FDA for the entirety of the pandemic," Zalewski told ishonest. "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.

Amanda D'Ambrosio is a reporter on ishonest’s enterprise & investigative team. She covers obstetrics-gynecology and other clinical news, and writes features about the U.S. healthcare system. Follow

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