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After Being Sued for Information, the FDA Releases the First Round of Pfizer Documents

The Food and Drug Administration (“FDA”) has released Pfizer’s report on adverse events to its Covid injection for the first two-and-a-half months since post-emergency authorisation.  Over this period Pfizer had received more than 42,000 reports, mostly from the United States.  Almost 30,000 of these adverse event reports were from women and 26,000 related to nervous system disorders.

“Four days after the Pfizer vaccine was approved for ages 16+, we submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s Covid-19 vaccine biological product file. We have now sued the FDA for not releasing the data.” – Public Health and Medical Professionals for Transparency (“PHMPT”).

A few days ago, two months after PHMPT had sued, the FDA released the first round of documents it reviewed before licensing Pfizer’s Covid injection. One of the documents released was an analysis of adverse event reports for the two-and-a-half months, since Emergency Use Authorisation (“EUA”) was given, up to 28 February 2021.

“Pfizer received a total of 42,086 reports containing 158,893 ‘events’.  Most of these reports were from the U.S. and disproportionately involved women (29,914 vs. 9,182 provided by men) and those between 31 and 50 years old (13,886 vs 21,325 for all other age groups combined, with another 6,876 whose ages were unknown).  Also, 25,957 of the events were classified as ‘Nervous system disorders’,” wrote Aaron Siri, a vaccine and civil rights attorney.

In Table 2, page 8, there is a more detailed breakdown of the adverse events.  It also lists 1,972 blood and lymphatic system disorders and 1,098 cardiac disorders.

Earlier this month, Siri testified at an expert panel led by Senator Ron Johnson that during the Covid crisis their phones have received an avalanche of requests. “If we actually sued all of the pharmaceutical companies for all of the complaints it would actually impossible for all of the attorneys around the country, around 100, to handle all of those matters,” Siri said.

During his testimony Siri describes the struggles Dr. Patricia Lee, an ICU doctor based in California, has had in trying to get health authorities to acknowledge Covid injection injuries.  She sent a letter to both the CDC and the FDA in which she explained observing more vaccine-related injuries than she had throughout the last 20 years.

The “vaccine” adverse effects listed in her letter depicted healthy people suffering serious and fatal injuries including transverse myelitis, resulting in quadriplegia, pneumocystis pneumonia, multi-system organ failure, cerebral venous sinus thrombosis, post-partum hemorrhagic shock and septic shock, and disseminated CMV and CMV viremia.  You can read Dr. Lee’s letter HERE.

Expert Panel on Medical Mandates and Vaccine Injuries, Washington D.C.,
3 November 2021 – Testimony Aaron Siri (9 mins)

Watch the full Expert Panel on Medical Mandates and Vaccine Injuries (3 hours) on The Highwire HERE. Siri’s testimony begins at 02:48:43 mins.

Table 3 of the analysis of Pfizer’s adverse events report details safety concerns and missing information. Anaphylaxis is identified as a risk and potential risks are vaccine-enhanced diseases.  Not included in Table 2 of adverse events was effects on pregnancy and lactation, children under 12 years old and vaccine effectiveness (lack of efficacy, drug ineffective and vaccine failure cases). However, details of “missing information” is given in Table 6 of Pfizer’s report.

On page 11 the report states: “no post-authorised [adverse event] reports have been identified as cases of VAED/VAERD, therefore, there is no observed data at this time. An expected rate of VAED is difficult to establish so a meaningful observed/expected analysis cannot be conducted at this point based on available data … VAED may present as severe or unusual clinical manifestations of Covid-19.”

In Table 2, page 9, there were 1,927 Covid infections and 4,151 respiratory, thoracic and mediastinal disorders listed.

Vaccine-associated enhanced diseases (“VAED”) are modified presentations of clinical infections affecting individuals exposed to a wild-type pathogen after having received a prior vaccination for the same pathogen. Vaccine-associated enhanced respiratory (“VAERD”) disease refers to disease with predominant involvement of the lower respiratory tract.

An article published in September, ‘Vaccine-Associated Enhanced Viral Disease: Implications for Viral Vaccine Development’, states: “VAED is a serious barrier to attaining successful virus vaccines in human and veterinary medicine. VAED occurs as two different immunopathologies, antibody-dependent enhancement (ADE) and vaccine-associated hypersensitivity (VAH).”

Pfizer’s report to the FDA includes an appendix listing “adverse events of special interest.”  It starts on page 30 and continues for a further 8 pages.

We begin to wonder if the FDA actually reviewed this information before licensing Pfizer’s Covid injection and if they did, how did they determine it was indisputably “safe and effective”?

Sources:


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8 days ago

[…] November 24, 2021After Being Sued for Information, the FDA Releases the First Round of Pfizer Documents […]

jim
jim
8 days ago

No mention of ICAN.org that filed the suit? Shame, shame

Meryl Fischer
Meryl Fischer
7 days ago

Under New York State’s Wrongful Death Statute, our Lives are worth our paychecks. The NYS bill to correct this inhumane law has been in Albany since 1994. Title: “An act to amend the estates, powers and trusts law, in relation to payment and distribution of damages in wrongful death actions”. New York is a murder for profit state. By their FAILURE TO ACT, New York State government ENABLES Negligent, Reckless, sometimes Criminal Behavior that leads to NEEDLESS DEATHS.