It took the US Food and Drug Administration 108 days to review all the data that Pfizer/BioNTech submitted for FDA approval for its Comirnaty COVID product licensed on August 3, 2021.
Considering the agency claims to have 329,000 pages of data, it’s a miracle that they were able to read, analyze, and draw conclusions about its safety and effectiveness in just 108 days – about 80,000 pages a month. small clown. They have to use some very efficient speed readers.
And that’s why the FDA’s claim that they now need half a century to review the documents before they can release them to the public doesn’t seem so believable. Even Reuters expressed shock, and its former CEO is on Pfizer’s board.first
Urgent FOIA request for confidential data
In September 2021, a group called Public Health and Healthcare Professionals for Transparency (PHMPT) filed a Freedom of Information Act (FOIA) request with the FDA to obtain the document used. used to approve Comirnaty.
This includes safety and efficacy data, adverse reaction reports, and lists of active and inactive ingredients. Approximately 400 additional FOIA requests by other individuals for all or part of this information have also been filed.2
In their FOIA application, PHMPT asked the agency to expedite the release of the documents – a reasonable request, given that we do not have the raw data and the warnings are being applied to children under 5. the age.
FOIA’s guidelines include two conditions for a claim to be resolved expeditiously. One is “if the lack of prompt treatment reasonably could pose a threat to someone’s life or physical safety,” which one could easily argue is the case. here.
The second condition is “if it is necessary to notify the public of an actual or alleged federal government activity, if carried out by a person primarily engaged in disseminating the information.” This also applies explicitly.
“During a time when COVID-19 vaccine regulations are being worked on due to opposition from those who have questions about the data and information supporting the safety and effectiveness of the Pfizer Vaccine, and Individuals with these questions will be expelled from work, school, and transportation. and the military, the public has an urgent and immediate need for access to this data,” PHMPT said in its request.3
FDA now wants 55 years of releasing COVID Jab . data
After a month, the FDA still did not respond to FOIA’s request, PHMPT sued.4 The FDA is now asking a federal judge to allow them to delay the full release of all documents until 2076 – 55 years from now.
According to an attorney for the US Department of Justice (DOJ), who is representing the FDA in this case, the agency would be able to “provide more pages to more claimants” if allowed to follow a rotation schedule. sessions of 500 pages per month, “thus avoiding a system where some large requests monopolize finite processing resources. ”
They claim they only have 10 staff members assigned to FOIA releases, and before the document can be released, an FDA official must go through them and redact any information that may be revealing. disclose personal information about clinical trial participants and any trade secret or trade secret information.
The FOIA Act of 1967 requires federal agencies to respond to the FOIA within 20 days unless there are “extraordinary circumstances” that prevent timely release. Circumstances that may warrant an extended release schedule include:
- Situations where response records must be sought and obtained from an organization other than the claims processing office
- Situations involving “huge” records must be aggregated, and
- Situations requiring consultation with another federal agency with a substantial interest in the information
DOJ attorneys point out that the court has allowed a release schedule of up to 500 pages per month in other cases and should allow the FDA similar time here.
The plaintiffs, on the other hand, argue that the agency could announce everything as early as March 2022, noting that the FDA employs 18,000 people and has an annual budget of $6 billion. Between 2008 and 2017, the agency processed 114,938 FOIA requests, of which the agency granted 72.4%, in whole or in part.
Of those, 39.8% were designated “complex” and 81.5% of these complex FOIA requests were granted in 61 days or more. Considering these historical stats, the backlog of 400 FOIA requests doesn’t seem overwhelming.
FDA Footsteps Is Suspicious
Then there’s the sticky issue that has proven its ability to quickly review. Aaron Siri of the law firm Siri & Glimstad wrote in the PHMPT court filing:5,6,7,8
“This 108-day period is the amount of time it took the FDA to review response documents for the much more complex task of licensing Pfizer’s COVID-19 vaccine…
It took the FDA exactly 108 days from the time Pfizer began producing records for approval until the FDA approved the Pfizer vaccine. In the words of the FDA, it conducted an intense, vigorous, thorough, and complete review and analysis of such documentation to ensure that the Pfizer vaccine was safe and effective for authorization.
While it was able to conduct an intense review of Pfizer’s documents in 108 days, it currently requires more than 20,000 days to make these documents available to the public…
The whole purpose of the FOIA is to ensure government transparency. It is hard to imagine a greater need for transparency than the immediate disclosure of documents the FDA relies on to authorize a product that is currently being ordered by more than 100 million Americans under penalty of loss of a career. , their income, their military service status, and much worse. ”
The shocking revelation of the first series of FOIA documents
Two months after the lawsuit was filed, the FDA released a series of 91 pages,9 and if this batch is any indication, it’s not surprising that the FDA wants to slow the release of the rest. In a summary article dated November 21, 2021, Kyle Becker quotes directly from the published documents:ten
“’It is estimated that about [REDACTED] doses of BNT162b2 have been shipped worldwide since receiving the first provisional authorization for an emergency supply on December 1, 2020 to February 28, 2021,’ the document states. ‘Cumulative to 28 February 2021, there have been a total of 42,086 case reports (25,379 medically confirmed and 16,707 medically unconfirmed) containing 158,893 events…
Most of the cases (34,762) were received from the United States (13,739), the United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866). ‘ Below is a General Overview of Results Reported for Adverse Events:
The chart lists 1,223 deaths in Related Cases. Interestingly, the age group with the most relevant cases is 31-50 years old, which is not an age group considered high risk for COVID-19.”
It is worth noting that by re-converting the number of indicated doses delivered, it becomes more difficult to assess potential injury rates. Even without that, however, 42,086 reports of injuries, including 1,223 deaths, are a significant signal, especially when you consider that the 1976 swine flu vaccine was withdrawn. out after 25 deaths.
Seeing life
It’s even more disturbing when you consider that 42,086 of those reports were received by Pfizer in just the first 2.5 months of its release. Pfizer even acknowledged the unusual rate of injuries, but then brushed it aside as if there were no consequences. As noted by Siri, in an article dated November 19, 2021, in which he discusses this first batch of documents:11
“Pfizer explains, on page 6, that” Due to the large number of spontaneous adverse event reports received for the product, [Pfizer] has prioritized handling serious cases…’
Pfizer’ also made a [sic] many actions to help alleviate the large rise in adverse event reports ‘including’ increasing the number of co-workers entering data and handling cases ‘and’ has given approx. [REDACTED] full-time staff (FTE). ‘
Query why Pfizer exclusively shared the number of people Pfizer had to hire to monitor all adverse events reported shortly after the launch of its product…
But there is no cause for alarm as Pfizer explained to the FDA: ‘The results of these signal detection analyzes are consistent with the vaccine’s known safety profile.’ So, if they know these issues will arise, why don’t they have enough staff to handle this expected volume of reports?
Pfizer’s key conclusion to the FDA: ‘The data do not reveal any new safety concerns or risks that require a label change and support the favorable benefit-risk profile of the BNT162b2 vaccine.’ There’s nothing to see here.”
Obviously, there’s a lot to be found in the hundreds of thousands of documents that Pfizer/BioNTech has filed with the FDA. The fact that the FDA is blocking it and wants 55 years to fix them before they’re appropriate for the public speaks volumes.
You don’t have to have a wild imagination to understand what they might be hiding. It seems like they want to make sure that all responsible parties are dead by the time all the data is made public and that everyone can be held accountable for their decisions. Let’s hope the judge cares more about public health than protecting FDA’s dirty secrets.
