FDA asks for 55 years to review its Pfizer-BioNTech data before releasing to public

In response to a Freedom of Information Act request (FOIA) filed over three months ago, in August of 2021, the U.S. Food and Drug Administration (FDA) has asked a federal judge for 55 years to review its data before releasing it to the public in its entirety. The data refers to the FDA’s decision to license what is now known as the Comirnaty vaccine against Covid-19, produced by Pfizer in collaboration with BioNTech. Back in November of 2020, when considering Pfizer-BioNTech’s request for emergency use authorization (EUA) of its product, the FDA promised that: “In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee … will meet to discuss the totality and safety and effectiveness data provided … The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data … so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves.” In September of 2021, when amending its EUA to include booster doses, the FDA reiterated its commitment to transparency, writing: “As we learn more about the safety and effectiveness of COVID-19 vaccines … we will continue to evaluate the rapidly changing science and keep the public informed…” The FDA noted at the time that it was studying data provided not only by Pfizer-BioNTech, but also from the “Israeli Ministry of Health, the University of Bristol, U.K. and the Centers for Disease Control and Prevention [CDC].” Meanwhile, a group of over 30 academics, professors, and scientists had submitted a request for the data the FDA had pledged to provide for public perusal. The group, known as the Public Health and Medical Professionals for Transparency (PHMPT) includes reputed professionals such as Professor Harvey Risch, an epidemiologist at Yale School of Public Health and others affiliated with Harvard, UCLA, and Brown. When a month passed without a response from the FDA, Siri & Glimstad LLP filed a lawsuit on behalf of PHMPT against the FDA requesting that the “Court enter an order requiring the FDA to produce all documents and data submitted by Pfizer … 108 days from today,” noting that, “This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s Covid-19 vaccine.” They added that, “To require less is to render FOIA meaningless, the FDA’s promise of transparency a lie, and to send a signal to every American that while the federal executive branch is shielding Pfizer from any liability for injuries from its product and requiring employers, schools, hospitals and the military to expel those that don’t receive this product, it is protecting the very documents Pfizer provided to our taxpayer-funded health agency to obtain licensure to be able to sell this product.” In its response, the FDA wrote: “FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month,” at which rate the entire body of data it intends to release (which is only the non-exempt portions) will not be released before the year 2076. The FDA further noted that, “Plaintiff’s request (as set forth below) that FDA process and produce the non-exempt portions of more than 329,000 pages in four months would force FDA to process more than 80,000 pages per month,” and explained that it lacked the necessary staff to process the data any faster. The FDA added that due to the nature of the data, it would be obligated to take especial care with releasing it in order to avoid compromising “confidential business and trade secret information of Pfizer of BioNTech…” which meant that it would have to go through the data “on a line-by-line basis.” “As should be apparent,” the FDA continued, “the review conducted by FDA scientists when considering to approve a product is entirely different from the review conducted by FDA government information specialists when considering whether FDA must keep certain information confidential.” Furthermore, the FDA denied that it was required to release the data in a timely fashion, writing that, “FDA’s regulations do not require or suggest that FDA will release all publicly releasable data immediately after a biologics license application is approved.” Responding to the FDA’s arguments, Aaron Siri of Siri & Glimstad said in a statement, “It was exactly 108 days for the FDA from the time Pfizer started releasing the licensing records to the time the FDA licensed the Pfizer vaccine. Taking the FDA’s word for it, it has conducted an intensive, reliable, thorough and complete review and analysis of these documents to ensure that Pfizer’s vaccine is safe and effective for licensing. While he can do a thorough review of Pfizer documents in 108 days, it now takes more than 20,000 days to make those documents publicly available.” En español aquí