FDA begins court-mandated release of thousands of pages on Pfizer's Covid-19 vaccine review
A court loss for the FDA in a Texas district court means the agency on Tuesday began to release a massive trove of hundreds of thousands of documents related to its review of Pfizer’s safe and effective Covid-19 vaccine.
But what exactly will be uncovered in each batch of released documents is anyone’s guess.
The nonprofit that won the court case, known as the Public Health and Medical Professionals for Transparency, promptly released the Pfizer documents on its website this week but did not offer any sort of organization or explanation of what they show.
Some of the documents, like one labeled as a priority review request, includes more than 100 pages worth of anonymous safety-related tables of data. Or another table of unidentified participants’ gender, age and BMI.
Other documents are typical for any drug or vaccine application. For instance, one document shows the standard, nearly $2.9 million user fee payment to FDA from Pfizer. Other documents released include the fast track designation letter, which is not typically released, the confidential nonclinical overview for the vaccine, Pfizer’s request for a waiver from adding a suffix to the vaccine’s name (also not typically released), and another with a long list of anonymized trial subjects who didn’t receive the vaccine as randomized.
The sheer volume of pages and document types will give readers a good overall sense of the required documentation necessary to apply for a drug or vaccine approval at the FDA. But it’s still unclear if the documents will offer any new insight into the vaccine’s safety or efficacy, especially given the real-world data on the vaccine that’s already been published in major medical journals (e.g. Pfizer’s vaccine effectiveness and safety in health care personnel or Israel).
Anti-vax lawyer Aaron Siri, a managing partner of the firm Siri & Glimstad who represented the nonprofit, told Endpoints News, “Our job was to get the documents. We leave it to the scientists and others to analyze.”
Previously Siri wrote on his Substack that what drove this suit was that the government “wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead.”
