FDA’s forced hand drops Pfizer’s Bombshell Safety Document

SoniaElijah

By Sonia Elijah

The highly confidential Pfizer documents, which have been synonymous with the extreme lack of transparency revealed by the actions of pivotal governmental agencies, over the past 20 months, lead critics of the official narrative to demand “show us the data,” is finally being revealed–well sort of, the first few hundred redacted pages out of a trove of 451,000.

What led to the disclosure?

The crack in Pfizer and the Food and Drug Administration (FDA) iron dome-style data safeguarding, arrived in the form of a Freedom of Information Act (FOIA) release with the request filed on August 27, 2021, to access all the Pfizer documentation that the FDA had relied on to authorize the Pfizer-BioNTech Covid-19 vaccine for emergency use authorization. An agency that has received a FOIA request is required to ‘determine within 20 business days after the receipt of any such request whether to comply with such request,’ as set out by the 1967 FOIA law. It took the FDA though three months to release the first 91 redacted pages, on November 20.

The FOIA request was issued by a group of over 30 scientists and academics who filed a civil action lawsuit against the agency because they failed to fully comply with the request, since less than 1% of the documentation was released and with the FDA taking the position that all the data would be shared by 2076. Subsequently, the governmental agency had the audacity to push the date back even further to 2096. This was due to their recent disclosure of the existence of thousands of additional pages, totaling 451,000 versus the originally stated 320,000 pages. However, the rate at which the FDA is willing to release the documentation has not changed and remains at 500 pages a month. It’s worth noting that it took the FDA only 108 days to review all of Pfizer’s documentation before authorizing the Pfizer BNT162B2 vaccine for emergency authorization use on December 1, 2020.

The scientists, public health officials and academics, led by Dr Peter McCullough, formed the plaintiff group, PHMPT (Public Health and Medical Professionals for Transparency) and are being represented by the law firm of Aaron Siri, of Siri & Glimstad LLP.

In an exclusive interview with Trial Site News, Aaron Siri, managing partner of the firm, who has extensive civil litigation experience, stated:

“The court has not ordered a single page to be produced yet. For the most part, when our firm submits a FOIA request, they [the agency] will produce documents but the FDA wants to do it at a pace that’s incredibly slow, not commensurate with the needs of the request. The fight is not whether they’ll produce it-they’ll produce it. The fight is how long it will take and then the fight once we get it will be the redactions they put in.

When I asked him whether FOIA requests will be made to obtain Moderna and Janssen’s (a subsidiary of Johnson and Johnson) documentation supplied to the FDA to secure emergency use authorisation, he responded:

“You can’t make a request until a vaccine has been licensed. Authorization for emergency use is not the same as licensure or approval. The Pfizer vaccine is the only vaccine that’s been licensed/approved as “safe and effective” according to the FDA on August 23rd2021.”

Details about the case and the relevant court documents can be found on Aaron Siri’s blog, Injecting Freedom.

The first several hundred pages of the newly released Pfizer documents were shared on the PHMPT’s website.

The focus of this investigative report centers on the 38-page document, entitled, “Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) received through 28 February 2021.” The report was prepared by Pfizer, between the time of December 1, 2020, through February 28, 2021. The adverse events reports originate in the United States, United Kingdom, Italy, Germany, France, Portugal, Spain and ‘56 other countries.

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.’

The many unknowns

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 centres 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.  

Other significant ‘unknowns’ peppered throughout Pfizer’s analysis are:

• 2990 cases where the gender is unknown
• 6876 cases where the age is unknown
• 9440 cases where the outcomes are unknown

Another anomaly that stands out is that for case outcomes, Pfizer has chosen to include those recovering from adverse events in the same category with those recovered, under the label, ‘Recovered/Recovering’.   This move alone seems questionable.

The large numbers of spontaneous adverse event reports

Alarmingly, the analysis makes note of the fact that there has been such a large volume of adverse events, classified as ‘serious cases’ in that short period of time, that Pfizer has had to take on more full-time employees and make significant technology changes to cope with the processing of the voluminous reports while also meeting regulatory reporting timelines.  As recorded in the document:

‘Due to the large numbers of spontaneous adverse event reports received for the product, the MAH has prioritized the processing of serious cases, to meet expedited regulatory reporting timelines and ensure these reports are available for signal detection and evaluation activity.’ The report went on to state how Pfizer has dealt with these large numbers of adverse event reports. ‘Pfizer has also taken 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 additional b4 full-time employees (FTEs)..’

(*b4 is a redacted term)

The 1228 Deaths

Within Pfizer’s self-generated document, a serious red flag surfaces:  1228 people were recorded to have died within three months after taking the vaccine, while no record accounts for the gender of the study participants who died. This data, which has significant safety implications, was known to Pfizer by end of February, yet on April 12, Dr Mace Rothenberg former Pfizer Chief Medical Officer, when talking to the Washington Journal about the development of the Pfizer vaccine said “I can tell you that no corners were cut” and “there have been no deaths that have occurred directly as a result of the vaccine alone.” Those defending the safety of the Pfizer vaccine have raised the argument that ‘correlation does not imply causation, in which two events occurring together does not establish a cause-and-effect relationship.

Page 10 of the Pfizer analysis presents an important identified risk of anaphylaxis with nine reported fatalities. Four out of the nine occurred on the same day the individuals were vaccinated (see below).

Pfizer emphasized that these individuals had underlying medical conditions but for all four of them to die on the same day that they were received the vaccine, suggests potential vaccinal death causality.

In Table 7 of pages 16-17, 1403 cases of Cardiovascular AESIs (Adverse Event of Specific Interest) were reported and segmented by the following: Arrhythmia; Cardiac Failure; Cardiac failure acute; Cardiogenic shock; Coronary artery disease; Myocardial infarction; Postural orthostatic tachycardia syndrome; Stress cardiomyopathy; Tachycardia.

The relevant event onset latency ranged from less than 24 hours to 21 days. This means that relevant events occurred from any time less than 24 hours up to 21 days of receiving the vaccine, with a median of less than 24 hours. 136 relevant event outcomes were fatal. Therefore, 50% of these relevant outcomes (including deaths) occurred less than 24 hours of receiving the vaccine. This points again to vaccine death causality.  

Yet, Pfizer somehow concludes: ‘This cumulative case review does not raise any new safety issues. Surveillance will continue.’

When looking at the category ‘Immune-mediated/Autoimmune AESIs’, 1050 cases were reported, with just over three times more females affected than males- there were 12 fatal outcomes. The median of the relevant event onset latency was less than 24 hours, which again suggests vaccine death causality.

The seriousness of the cases

Looking at the graph below, a significant portion of cases are reported as serious compared to non-serious with the highest number of serious cases in the ‘general disorders’ category. A serious case is one that is medically significant resulting in either hospitalization or that has a life-threatening consequence or death. It’s interesting to note that for cardiac, immune, vascular, and infections, serious cases dominate and for immune cases, all are classified as serious.

Women were x3 times more affected by adverse events from the vaccine.

Across the board, in every category of AESI (adverse events of special interest), women were generally three times more adversely affected than men. However, nowhere was this as pronounced as in the case of anaphylaxis (a potentially life-threatening allergic reaction), where women were over eight times more affected. Out of the 1002 anaphylaxis cases reported meeting the Brighton Collaboration level of 1-4 (level 1 being the highest level of diagnostic certainty of anaphylaxis) 876 females were affected compared to 106 males. Women were also significantly more affected by cardiovascular events; 1076 females were reported as cases compared to 291 males. The statistically significant data reveals the real possibility of gender-specific vaccine safety risks.

Yet nowhere in Pfizer’s analysis does the company comment on this data, but instead confidently reasserts, ‘the cumulative case review does not raise any new safety issues.’

The missing information

Also noteworthy, the data associated with the ‘Use in pregnancy and lactation’ were somehow excluded in the original analysis submitted to the FDA. In the amended version, 413 adverse cases are reported with 84 classified as serious.

Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23), outcome pending (5), premature birth with neonatal death, spontaneous abortion with intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome (1 each).

It’s alarming that Pfizer makes the assertion that ‘there were no safety signals that emerged from the review of these cases of use in pregnancy and while breastfeeding.’  The data contained in the heavily redacted document appears to contradict this upbeat assessment.

In pediatric individuals < 12 years of age, which was originally missing from Pfizer’s analysis, 34 cases were reported with 24 categorized as serious. The fact young children were administered the Pfizer vaccine raises concern since emergency use authorization was not awarded to the company to administer to the pediatric population at that time. Moreover, the age range raised considerable alarm given its ‘from 2 months to 9 years.’ The report lacks data on how many children in total were administered the vaccine, hence, there is no way of calculating incidence rates to extrapolate a meaningful analysis.

A sample list of the known AESIs in Pfizer’s cumulative analysis.

Blood and lymphatic system disorders: Lymphadenopathy

Cardiovascular events: acute myocardial infarction; Arrhythmia; Cardiac failure; Cardiac failure acute; Cardiogenic shock; Coronary artery disease; Myocardial infarction; Postural orthostatic tachycardia syndrome; Stress cardiomyopathy; Tachycardia

Gastrointestinal disorders

General disorders and administration site conditions

Infection and infestations

Musculoskeletal and connective tissue disorders: Arthralgia; Arthritis; Arthritis bacterial; Chronic fatigue syndrome; Polyarthritis; Polyneuropathy; Post viral fatigue syndrome; Rheumatoid arthritis

Nervous system disorders

Respiratory, thoracic, and mediastinal disorders: Lower respiratory tract infections; respiratory failures, Viral lower respiratory tract infections; acute respiratory distress syndrome; Endotracheal intubation; Hypoxia; Pulmonary hemorrhage; Respiratory disorder; Severe acute respiratory syndrome

Skin and subcutaneous tissue disorders

Anaphylaxis

Vaccine-Associated enhanced Disease (VAED) including Vaccine-associated enhanced respiratory disease (VAERD).

COVID-19

Facial paralysis

Immune-Mediated/Autoimmune disorders

Neurological (including demyelination): Convulsions; Ataxia; Cataplexy; Encephalopathy; Fibromyalgia; Intracranial pressure increased; Meningitis; Meningitis aseptic; Narcolepsy

Pregnancy-Related: Amniotic cavity infection; Caesarean section; Congenital anomaly; Death neonatal; Eclampsia; Foetal distress syndrome; Low birth weight baby; Maternal exposure during pregnancy; Placenta praevia; Pre-eclampsia; Premature labor; Stillbirth; Uterine rupture; Vasa praevia

Renal: Acute kidney injury, renal failure

Thromboembolic events: Embolism and thrombosis; Stroke AESIs, Deep vein thrombosis; Disseminated intravascular coagulation; Embolism; Embolism venous; Pulmonary embolism

It’s worth comparing the list above with the list below accessed via the FDA’s website under the document ‘Pfizer-BioNTech fact sheet for recipients and caregivers’, revised as of Dec 9, 2021. It’s evident to see that many of the serious and life-threatening side effects have not been included, even though Pfizer’s cumulative analysis of post-authorization adverse event reports was produced for the FDA on April 30, 2021.

Conclusion

While this author strives to remain as objective and unbiased as humanly possible, a thorough review of this one report suggests that the FDA and Pfizer have appeared to conceal the full extent of the Pfizer-BioNTech vaccine side effects from the public. If this assumption is in fact true, then the ‘Gold Standard’ regulatory agency and the prestigious multinational pharmaceutical company have thrown the entire concept of informed consent out the window.

It’s also a travesty that months later, the FDA dragged its feet and released this important safety document based on adverse event case reports under FOIA law. Case reports play an important role in pharmacovigilance. The recognition of the link between thalidomide given to mothers and malformations in their babies was triggered by a case report.

Perhaps even more devastating—and a mockery of the whole point of advanced regulatory systems meant to ensure public safety–would be if the FDA wins the ongoing dispute to delay information release, then the public must wait another 75 years to access all the data, which by then will be far too late.

Source: Trial Site News