What Media "Is" is Partly in What It Will Not Say
Earlier this month, a US judged ruled that the FDA must release Pfizer Covid-19 gene therapy documentation at a rate of 55,000 pages per month starting in March. The FDA had tried to effectively block the underpinning FOIA request for these documents by restricting page release to a rate of 500 a day, meaning that the whole trove of at least 329,000 pages would take 55 years. In the latter stages of the case the FDA requested to push that back to 75 years. Reasons given for this timeframe were the resources of the FDA in releasing de-identified electronic data. It took the FDA 108 days to review those 329,000+ pages in the course of issuing an Emergency Use Authorisation for Pfizer’s Covid-19 gene therapy.
The FDA can read pages, analyse complex data and make regulatory decisions for brand new medical products quicker than it can upload electronic pages to a server.
You can follow Aarons Siri’s multipost account of the trial on his substack, “Injecting Freedom”: Aaron Siri - Injecting Freedom
The first 500 page release of the documents included a document titled “Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) received through 28 February 2021”.
Sonia Elijah’s article FDA’s forced hand drops Pfizer’s Bombshell Safety Document provides an interesting and lengthy commentary of the document in which she highlights the following:
It’s interesting to note that the artifact represents an amended analysis provided by Pfizer, a response to their failings associated with the incomplete submittal of a safety data package to the FDA, which the agency commented on. A reference is made to the FDA’s March 9th request to Pfizer ‘We are most interested in a cumulative analysis of post-authorization safety data to support your future BLA submission. Please submit an integrated analysis of your cumulative post-authorization safety data, including U.S. and foreign post-authorization experience, in your upcoming BLA submission. Please include a cumulative analysis of the Important Identified Risks, Important Potential Risks, and areas of Important Missing Information identified in your Pharmacovigilance Plan, as well as adverse events of special interest and vaccine administration errors (whether or not associated with an adverse event). Please also include distribution data and an analysis of the most common adverse events. In addition, please submit your updated Pharmacovigilance Plan with your BLA submission.’
Elijah goes on to discuss the adverse event data in overview:
In the short three-month period in which the data was ‘reported spontaneously to Pfizer,’ 42,086 cases were recorded with 158,893 events. According to the data, one can interpret that the average person (case) would have suffered from just under four symptoms (events). Particularly troubling, the FDA opted to protect Pfizer’s interests by redacting the total number of doses to (b) (4), hindering the ability to calculate the incidence rates and provide a meaningful analysis of the data. Another deeply concerning fact centers on important limitations cited by Pfizer: ‘the magnitude of underreporting is unknown.’ In relation to this topic, investigators leading a prominent Harvard study conducted from 2007-2010, discovered that ‘less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the FDA.’ Assuming this math is correct, we can conclude that the 42,086 cases represent a staggeringly underreported amount.
A UXB or under-reported bombshell?
This confidential Pfizer document reporting adverse events up to February 2021 paints the term “safe” in a different light. Despite its shock value, it has garnered relatively few column inches in the British print media.
The FDA case has been partly reported by The Daily Mail, but not by:
The Guardian
The Financial Times
The Times
The Telegraph
The Express
The Sun
The BBC
Why not?