by Sharon Rondeau
(Nov. 20, 2021) — On September 16, the Public Health and Medical Professionals for Transparency (PHMPT) filed suit against the U.S. Food & Drug Administration (FDA) for its failure to release documentation sought under a Freedom of Information Act (FOIA) filed in August pertaining to its “approval” of a COVID-19 vaccine.
The documents pertain to the agency’s August 23, 2021 approval of a Biologics License Application (BLA) for the “Comirnaty” COVID-19 vaccine manufactured jointly by Pfizer and BioNTech.
The FOIA request had sought “All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)1 with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.” The system’s acronym is VAERS, whose data on reported side effects of vaccines are released each Friday current to the previous Friday.
“The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older,” the FDA’s August 23 press release reads. “The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
In the same release, the FDA wrote:
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
There are conflicting reports as to whether or not Comirnaty is available in the United States at this time, and an inquiry sent by this writer to the FDA in late September on that point received no response.
The CDC has stated that COVID-19 vaccines, even those approved under an Emergency Use Authorization (EUA), are “safe and effective.”
In early August, CDC Director Dr. Rochelle Walensky admitted that “breakthrough” cases of COVID-19 could occur in the vaccinated and that “transmission” of the virus from a vaccinated individual to others is possible.
Some researchers have additionally found the vaccines “do not prevent infection,” and according to NIAID Director Dr. Anthony Fauci, hospitalizations of the vaccinated are increasing.
On June 7, the CDC reported that “COVID-19 vaccines are effective and should prevent most infections — but that fully vaccinated people who still get COVID-19 are likely to have milder, shorter illness and appear to be less likely to spread the virus to others. These benefits are another important reason to get vaccinated.”
“Fully vaccinated” signifies two doses of the Pfizer mRNA or Moderna vaccine or a single dose of the Johnson & Johnson “Janssen” viral-vector product, according to the CDC, which on Friday approved “booster” shots for anyone aged 18 and over and recommended them for specific groups of people.
However, Fauci has suggested that booster shots should become part of the COVID-19 injection regimen.
An attorney representing the plaintiffs, Aaron Siri of Siri Glimstad, spoke at a November 1 roundtable held by U.S. Sen. Ron Johnson (R-WI) focused on what Johnson said is the federal health system’s lack of “transparency” and “honesty” regarding the COVID-19 vaccines and reported adverse reactions. Johnson additionally decried White House occupant Joe Biden’s mandates for government and private employers to require their workforce take the vaccination or submit to weekly testing at their own expense.
During his address, Siri explained (2:49:20) that vaccine manufacturers are protected by federal law from liability for injuries and that any compensation which might be paid in the event of a successful COVID-19 claim is “de minimus, for the most part.”
Physicians who themselves suffered COVID-19 vaccine injuries and submitted reports to VAERS expected follow-up from the FDA and CDC which never occurred, Siri reported. A physician who made known her observations of serious patient vaccine injuries, Dr. Patricia Lee, in a September 28 letter to the FDA received no initial response, he said, after which Lee sought his firm’s assistance (2:54:00).
After he became involved, Siri said, the FDA responded and “eventually” met with Lee, after which FDA representatives responded with silence. “And what did they tell her? ‘Nothing to see,'” Siri said.
Lee’s actions gave way to 11 other physicians submitting “declarations,” Siri said, displaying them briefly, attesting to “similar catastrophic injuries from COVID-19 vaccines as detailed by Dr. Lee.”
The government’s response was, “Everything’s fine,” Siri stated.
Some of the physicians’ declarations redacted their identities and contact information, Siri said, because of fear of retaliation from the medical establishment.
A number of individuals who suffered injuries from COVID-19 vaccines attended the three-hour session and in turn described their experiences, which ranged from severe tinnitus, uncontrollable trembling, spinal injuries and paralysis, gastrointestinal difficulties, vision problems, weakness and neurological symptoms.
Between sobs, Ernest Ramirez spoke for his deceased 16-year-old son, who in April collapsed and died five days after taking the Pfizer vaccine. His cause of death was reportedly an enlarged heart.
“Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. (5.2),” the Comirnaty package insert reads on page 1.
According to Dr. Peter A. McCullough, MD, MPH and a member of PHMPT, the number of deaths reported to VAERS as of late January should have caused the U.S. COVID-19 vaccine program to be “shut down.” In lectures he has given around the country and internationally, McCullough has said the “sponsors” of the COVID-19 vaccination program are the FDA and CDC “and then behind them, Pfizer, Moderna and J&J,” and that no data and safety monitoring board is currently in place to oversee the experimental program’s rollout.
The Post & Email’s query to the National Institutes of Health (NIH) in October as to whether or not a DSMB is in place for COVID-19 vaccines went unanswered.
In a response to the lawsuit last week, the FDA proposed a release schedule of 500 pages a month of a total of 329,000 relevant pages it said exist, which equates to a total of 55 years for all documents to be released.
Siri’s firm and the Howie Law Firm have argued that all documents should be released in 108 days, “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.”
On Friday, Siri posted on his Substack an article titled, “FDA Produces the First 91+ pages of Documents from Pfizer’s COVID-19 Vaccine File.” In the post, he wrote:
Two months and one day after it was sued, and close to 3 months since it licensed Pfizer’s Covid-19 vaccine, the FDA released the first round of documents it reviewed before licensing this product. The production consisted of 91 pdf pages, one xpt file, and one txt file. You can download them here.
While it is for the scientists to properly analyze, let me share one observation. One of the documents produced is a Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021, which is a mere 2 ½ months after the vaccine received emergency use authorization (EUA). This document reflects adverse events following vaccination that have completed Pfizer’s “workflow cycle,” both in and outside the U.S., up to February 28, 2021.
Pfizer explains, on page 6, that “Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritised the processing of serious cases…” and that Pfizer “has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional fulltime employees (FTEs).” Query why it is proprietary to share how many people Pfizer had to hire to track all of the adverse events being reported shortly after launching its product.
The Post & Email found the first two files of five indecipherable with the Firefox browser. The third file, titled, “5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports” under the category, “postmarketing experience,” was written by “Worldwide Safety, Pfizer” and begins:
The information contained in this document is proprietary and confidential. Any disclosure, reproduction, distribution, or other dissemination of this information outside of Pfizer, its Affiliates, its Licensees, or Regulatory Agencies is strictly prohibited. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except where required by applicable law), nor to use it for unauthorized purposes.
On page 6, Pfizer reported:
Due to the large numbers of spontaneous adverse event reports received for the product, the MAH has prioritised the processing of serious cases, in order to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity. The increased volume of reports has not impacted case processing for serious reports, and compliance metrics continue to be monitored weekly with prompt action taken as needed to maintain compliance with expedited reporting obligations. Non-serious cases are entered into the safety database no later than 4 calendar days from receipt. Entrance into the database includes the coding of all adverse events; this allow for a manual review of events being received but may not include immediate case processing to completion. Non-serious cases are processed as soon as possible and no later than 90 days from receipt. Pfizer has also taken a multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately (b)(4) additional full-time employees (FTEs). More are joining each month with an expected total of more than (b)(4) additional resources by the end of June 2021.
The figures in parentheses indicate the FDA’s claims of exemptions from release under FOIA.
At the bottom of page 6, Pfizer reported:
Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866) and Spain (756); the remaining 7,324 were distributed among 56 other countries.
Adverse events reported to Pfizer between December 1, 2020 and February 28, 2021 included:
anaphylaxis (1833, p. 10);
the contraction of COVID-19 after vaccination (138 “serious” cases [includes “suspected” and “confirmed” cases], p. 11);
124 pregnancies (“49 non-serious and 75 serious,” p. 12);
1100 “medically confirmed” cases of a total of 1665 reports of “lack of efficacy,” p. 12;
241 confirmed cardiac events out of a total of 1403 reported (p. 16);
Seizures and Guillain-Barre syndrome, among other neurological disorders, p. 21
“Thromboembolic Events,” of which 111 of 151 were “medically confirmed,” p. 23
Medication errors, which led to seven deaths and other serious outcomes, p. 16
On page 28, Pfizer reported:
Pfizer performs frequent and rigorous signal detection on BNT162b2 cases. The findings of these signal detection analyses are consistent with the known safety profile of the vaccine. This cumulative analysis to support the Biologics License Application for BNT162b2, is an integrated analysis of post-authorization safety data, from U.S. and foreign experience, focused on Important Identified Risks, Important Potential Risks, and areas of Important Missing Information identified in the Pharmacovigilance Plan, as well as adverse events of special interest and vaccine administration errors (whether or not associated with an adverse event). The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of to the BNT162b2 vaccine.
For all three COVID-19 vaccines used or manufactured in the U.S., VAERS figures released November 19 reflective of data through November 12, 2021 show a total of 18,853 reported deaths worldwide, with 8,664 of those in the U.S.; and 654,412 U.S. adverse events of a total of 894,143 “Vaccine Adverse Event Reports” worldwide.
As reported by Sharyl Attkisson on Friday, in a November 8 bulletin, the U.S. Department of Labor reported “receiving an increased number of claims resulting from apparent adverse reactions to the COVID-19 vaccination,” issuing instructions to federal employees as to the process for claiming compensation for their injuries. “No word as to who, if anyone, is considered liable for vaccine injuries in private industry when companies require Covid-19 vaccination,” Attkisson wrote in her post.
12:53 p.m.: This post was updated with information reported by Sharyl Attkisson.