Thursday, 07 November 2024

The devastating charge sheet against Pfizer


bourla
© Getty ImagesDr. Albert Bourla, Chairman & CEO, Pfizer
We've extracted the main points from the Kansas City Attorney General's legal report on the case against Pfizer that we first mentioned in 'Due Process' — all quotes are taken verbatim.

This is a lengthy post, and we'd recommend having an anger management strategy to hand while reading. If you are making a comment, use the numbering to highlight which points you are referring to, and do let us know if we've missed anything.

1. Pfizer misled the public.

- In May 2021, Pfizer advertised to Kansans on Facebook about its "life-saving vaccines" and its "cures". Upon information and belief, Pfizer intended for Kansans to think of its COVID-19 vaccine when it discussed "life-saving vaccines" and "cures". Pfizer ran three different ads between May 4th 2021 and June 1st 2021 that received 165,000 to 190,000 impressions.

- Pfizer received emergency use authorisation for its COVID-19 vaccine in individuals 16 years of age and older on December 11th 2020.

- Pfizer received FDA approval on August 23rd 2021. From 2021 to 2023, Pfizer received emergency use authorisations in children from six months to 15 years of age.

2. Pfizer used confidentiality agreements to conceal critical data relating to the safety and effectiveness of its COVID-19 vaccine.

- Pfizer effectively had a veto over the federal Government's communications.

3. Pfizer used its confidentiality agreements with the U.S. Government and others to conceal, suppress and omit material facts relating to Pfizer's COVID-19 vaccine, including the safety and efficacy of the vaccine.

4. Pfizer used an extended study timeline to conceal critical data - the study was repeatedly delayed.

- Pfizer planned to provide researchers with access to patient-level data and full clinical study reports 24 months after study completion. Protocol C4591001

- Pfizer estimated that it would complete the study by January 27th 2023, but that estimated date fell back to February 2024 because of a late vaccination of a single study participant (out of 44,000 participants).

- Pfizer's control of the data allowed the company to selectively publish results for which the underlying data could not be independently evaluated.

5. Pfizer says it will make data from vaccine trials approved in the U.S. available 18 months after the primary study completion date. Pfizer, Data Access Requests.

- Upon information and belief, Pfizer has still not made its complete study data available to researchers.

6. The FDA did not make the safety and effectiveness data for Pfizer's COVID-19 vaccine immediately available.

- The FDA denied expedited processing of PHMPTA's FOIA request and claimed in litigation that it would take 55 years — until 2076.

- In January 2022, a federal judge rejected the FDA's proposed production of 500 pages per month and ordered the FDA to instead produce 55,000 pages per month.

7. Pfizer destroyed the vaccine control group.

- Pfizer planned to follow COVID-19 vaccine study participants, both vaccine and placebo recipients for 24 months to monitor the safety and effectiveness of its vaccine.

- Once the FDA approved Pfizer's COVID-19 vaccine through an emergency use authorisation in December 2020, Pfizer unblinded the study participants and offered vaccine placebo recipients the option to receive the Pfizer COVID-19 vaccine.

- Only 1,544 placebo participants had not received the vaccine as of March 13th 2021, just 7% of the original placebo group.

8. In its press release announcing emergency use authorisation of its COVID-19 vaccine, Pfizer did not disclose that it had excluded immunocompromised individuals from its COVID-19 vaccine trials.

- Instead, in "Important Safety Information" in its press release, Pfizer noted that [i]mmunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine.

9. Pfizer knew its COVID-19 vaccine was connected to serious adverse events, including myocarditis and pericarditis.

- Pfizer maintained its own adverse events database that "contain[ed] cases of [adverse events (AEs)] reported spontaneously to Pfizer, cases reported by the health authorities, cases published in the medical literature, cases from Pfizer-sponsored marketing programmes, non-interventional studies and cases of serious AEs reported from clinical studies regardless of causality assessment.

- Upon information and belief, Pfizer's adverse events database contained more adverse event data than VAERS because it included both information in VAERS and information not in VAERS.

10. The United States military detected a safety signal for myocarditis.

- In early 2021, the U.S. military noticed cases of myocarditis in male military members occurring within four days of administration of Pfizer's COVID-19 vaccine.When the Department of Defence reviewed its health system data for 2021, it found that "[t]hose who were recently vaccinated had a rate ratio that showed their incidences of myocarditis and pericarditis were 2.6 and 2.0 times higher compared to those who were never vaccinated".

- On March 3rd 2021, Israel's Ministry of Health contacted the CDC about myocarditis and pericarditis connected to Pfizer's COVID-19 vaccine: "We are seeing a large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine. We would like to discuss the issue with a relevant expert at CDC."

- Upon information and belief, Pfizer had knowledge of the medical reports in Israel related to its vaccine and myocarditis and pericarditis because Israel agreed to share medical data with Pfizer.

- At the time of Pfizer Chairman and CEO Dr. Bourla's January 18th 2023 denial of any safety signals, the CDC's website reported that "[d]ata from multiple studies show a rare risk for myocarditis and/or pericarditis following receipt of mRNA COVID-19 vaccines".

- According to a leaked confidential February 2022 Pfizer document, "[s]ince April 2021, increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna), particularly in adolescents and young adults (CDC 2021)".

11. After Pfizer obtained FDA approval through emergency use authorisation to provide its COVID-19 vaccine to 12-15-year-olds in August 2021, Pfizer decided to study "how often" its vaccine may cause myocarditis or pericarditis in children by testing 5-16 year-olds for troponin I.

- Pfizer warned children participants that after receiving Pfizer's COVID-19 vaccine,"[y]ou might get chest pain, shortness of breath, or feelings of having a fast-beating, fluttering or pounding heart. You may need to come in to see the study doctor for further assessments if you have these symptoms".

- Pfizer press releases did not disclose an increased risk of myocarditis from Pfizer's COVID-19 vaccine until November 2021. Posts falsely claim Pfizer "officially admits" heart inflammation is COvid jab side-effect in 2023.

- Upon information and belief, at the time of Pfizer Chairman and CEO Dr. Bourla's January 2023 representation that Pfizer had not observed a single safety signal related to Pfizer's COVID-19 vaccine, Pfizer was aware of a safety signal relating to myocarditis and pericarditis.

12. Upon information and belief, Pfizer also detected a safety signal relating to strokes.

- Days before Pfizer Chairman and CEO Dr. Bourla denied any safety signal, the CDC's and FDA's "surveillance system flagged a possible link between the new Pfizer-BioNTech bivalent COVID-19 vaccine and strokes in people aged 65 and over.

- Although CDC later suggested a link was "very unlikely", an FDA study found that individuals 85 years or older who received both a flu vaccine and Pfizer's COVID-19 vaccine "saw a 20% increase in the risk of ischemic stroke".

13. Pfizer's knowledge of a safety signal for increased fatalities

- Upon information and belief, Pfizer also detected a safety signal relating to deaths. As of February 28th 2021, Pfizer's adverse events database contained 1,223 fatalities after taking Pfizer's COVID-19 vaccine.

14. Pfizer only tested the booster shot on 12 trial participants who were in the 65 to 85 year-old age range.

- Pfizer should not have represented that the booster was "safe" for 65 to 85 year-olds after only testing 12 trial participants in that age range.

15. Pfizer did not test the booster on any participant older than 85 years old.

- Pfizer should not have represented that the booster was "safe" for individuals 85 years old and older when it had not tested any trial participants in that age range.

16. Pfizer did not publicly release adverse event data from its database.

- As of February 28th 2021, Pfizer's adverse events database contained 158,893 adverse events (from 42,086 case reports) from its COVID-19 vaccine.

- As of February 28th 2021, Pfizer's database contained 1,223 fatalities after taking Pfizer's COVID-19 vaccine, although Pfizer did not make causality findings.

- Pfizer was receiving so many adverse events reports that it had to hire 600 additional full-time staff and expected to hire more than 1,800 additional resources by June 2021.

- Pfizer had such a backlog of adverse events that it might take 90 days to code "nonserious cases." Pfizer did not know "the magnitude of under-reporting.

17. Pfizer announces study on pregnant women but omits material facts already in its possession.

- More than one-in-10 women (52) who received Pfizer's COVID-19 vaccine during their pregnancy reported a miscarriage, many within days of vaccination.

- Six women who received Pfizer's COVID-19 vaccine during their pregnancy reported premature deliveries; several babies died.

18. Pfizer's February 18th 2021 press release also did not disclose other adverse effects on the reproductive systems of women who received Pfizer's COVID-19 vaccine.

- For example, by April 2022, Pfizer knew of tens of thousands of adverse events connected to its COVID-19 vaccine including heavy menstrual bleeding (27,685), menstrual disorders (22,145), irregular periods (15,083), delayed periods (13,989), absence of periods (11,363) and other reproductive system effects.

19. Pfizer's study on pregnant women failed and the results are secret.

- Pfizer sought to study approximately 4,000 healthy pregnant women. Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women, February 18th 2021. However, Pfizer only enrolled a fraction of this amount (683) in its study.

- Upon information and belief, Pfizer destroyed the placebo control group during the study, preventing Pfizer from evaluating differences in safety and efficacy between vaccinated pregnant women and unvaccinated pregnant women.

- Although Pfizer completed its study of its COVID-19 vaccine on pregnant women on July 15th 2022, it still has not completed the quality control review process for the study.

20. Pfizer concealed critical safety information from the public.

- Pfizer only tested its COVID-19 vaccine on healthy individuals. Pfizer's representations that its COVID-19 vaccine did not have any safety concerns failed to disclose the material facts that it had only been tested on healthy individuals.

21. Pfizer claimed that a "primary endpoint" of the trial of its COVID-19 vaccine was "prevention of COVID-19″ regardless of whether participants have previously been infected by SARS-CoV-2.

- Pfizer's statement was misleading since it had excluded any individual who had been diagnosed with COVID-19 from its vaccine trial.

22. Pfizer misrepresented and concealed material facts relating to the durability of protection provided by its COVID-19 vaccine.

- In November 2020, Pfizer announced, "[p]rimary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose".

- Pfizer did not report the absolute risk reduction of its COVID-19 vaccine, which was just 0.84%. On February 25th 2021, when asked in an interview how long Pfizer's COVID-19 two-dose vaccine provided protection, Pfizer Chairman and CEO Dr. Bourla stated, "at six months, the protection is robust".

23. On April 1st 2021, Pfizer issued a press release that celebrated "high efficacy" in Pfizer's COVID-19 vaccine through up to six months after the second dose.

- Pfizer represented that "[a]nalysis of 927 confirmed symptomatic cases of COVID-19 demonstrates BNT162b2 is highly effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second dose".

- Pfizer cited data in its press release that also appear in a Pfizer efficacy summary document.

- In its efficacy summary document, Pfizer reported an 83.7% efficacy rate four months after the second dose of its COVID-19 vaccine.

- In its efficacy summary document, Pfizer reported blood sample data showing effectiveness continued to wane at six months.

24. Pfizer said its COVID-19 vaccine would prevent transmission even though it knew it had never studied the effect of its vaccine on transmission.

- When the FDA issued the Emergency Use Authorisation for Pfizer's COVID-19 vaccine in December 2020, the FDA reported that there was no "evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person".

- According to Pfizer's trial protocol, evaluating transmission was not an objective of the trial.

25. Despite admissions by Pfizer Chairman and CEO Dr. Bourla and Board Member Dr. Scott Gottlieb that Pfizer did not know if its vaccine prevented transmission, Pfizer Chairman and CEO Dr. Bourla warned Kansans on multiple occasions that not receiving a COVID-19 vaccine would affect the lives of those around them, thus implying that Pfizer's COVID-19 vaccine prevented transmission.

- "I repeat once more, that this choice not to vaccinate will not affect only your health or your life. Unfortunately, it will affect the lives of others and likely the lives of the people you love the most, who are the people that usually you are in contact with." Pfizer Chairman and CEO Albert Bourla CNBC, December 14th 2020.

- "What I would say to people who fear the vaccine is that they need to recognise that the decision to take it or not will not affect only their own lives. It will affect the lives of others. And most likely it will affect the lives of people that they love the most, who are the people that they socialise the most with." John Micklethwait, Pfizer CEO Bloomberg, January 28th 2021.

- June 2021: "I try to explain to them that the decision to vaccinate or not is not only going to affect only your life... But unfortunately will affect the health of others and likely will affect the health of people you like and you love the most... When you try to explain that their fear could stand in the way of protecting their loved ones, I think this is the argument that mostly works. CEO, CBS News, June 15th 2021.

- November 2021: "The only thing that stands between the new way of life and the current way of life, frankly, is the hesitancy to get vaccinated, the people that are afraid to get the vaccines, and they create issues not only for them. Unfortunately, they are going to affect the lives of others and, frankly, the lives of the people that they love the most because they are putting at risk the people that they hug, they kiss, [and] they socialise with." Pfizer's Albert Bourla

- In December 2021, a Pfizer press release quoted Chairman and CEO Dr. Bourla in a manner that again suggested that Pfizer's COVID-19 vaccine prevented transmission: "Ensuring as many people as possible are fully vaccinated with the first two dose series and a booster remains the best course of action to prevent the spread of COVID-19."

- Pfizer Board Member Dr. Scott Gottlieb also represented to Kansans that Pfizer's COVID-19 prevented transmission: "And final point, I mean, some of the optimism is also being driven by growing science, suggesting that these vaccines, all the vaccines not only prevent Covid disease, prevent symptoms, but also prevent transmission. So they could have a dramatic effect on reducing the overall tenor of the epidemic." CBS News, March 7th 2021.

- In 2022, Pfizer partnered with Marvel to produce an Avengers-themed comic book that called individuals waiting for a Pfizer COVID-19 vaccine "Everyday Heroes".

- According to one of the characters in the Pfizer comic book, "it's also important for entire communities to come together and help fight the threat". "And that's exactly what we're doing today!" says another character. As the group heads to the examination room to get their Pfizer COVID-19 vaccinations, the first character announces, "The Avengers are doing their part to help keep us safe. Now it's time for us to do ours."

- One of the final pages reinforces the need for individuals to get a Pfizer COVID-19 vaccine in order to protect the community. "Everyday heroes don't wear capes! But they do wear a small bandage on their upper arm after they get their latest COVID-19 vaccination — because everyday heroes are concerned about their health. And they're people who choose to unite with their communities and do their part to help protect against COVID-19." See: 'Avengers Assemble! Teaming Up with Marvel to Illustrate the Importance of COVID-19 Vaccination' and 'Avengers: Everyday Heroes'

26. Pfizer worked to censor speech on social media that questioned Pfizer's claims.

- Pfizer's view was that "misinformation spreaders" are "criminals" who have"literally cost millions of lives".

- On July 19th 2021, Pfizer Board Member Dr. Scott Gottlieb claimed social media companies had an "obligation" and an "affirmative responsibility" to prevent the spread of COVID-19 vaccine misinformation on their platforms.

- Pfizer Chairman and CEO Dr. Bourla called people who spread misinformation on COVID-19 vaccines "criminals" who have "literally cost millions of lives."

27. Pfizer worked to conceal and suppress material facts.

- On August 24th 2021, Pfizer Board Member Dr. Scott Gottlieb contacted Twitter to complain about a column written by Alex Berenson that criticised Dr. Anthony Fauci. "This is whats [sic] promoted on Twitter. This is why Tony needs a security detail."

- On August 27th 2021, Pfizer Board Member Dr. Scott Gottlieb had a conference call with Twitter employees to discuss Mr. Berenson. Twitter banned Mr. Berenson the next day.

- On Friday, August 27th 2021, Dr. Brett P. Giroir, who served as the Assistant Secretary for health from 2018 to 2021 and approximately one month as the acting FDA Commissioner in late 2019, posted to Twitter that natural immunity was superior to vaccine immunity.

- In response, Pfizer Board Member Dr. Scott Gottlieb reached out to Twitter's top lobbyist in Washington, D.C., to complain that the post was "corrosive", "draws a sweeping conclusion" and "will end up going viral and driving news coverage".

- The Twitter lobbyist forwarded Pfizer Board Member Dr. Scott Gottlieb's email to the Twitter "Strategic Response" team, which "later slapped [Girori's tweet] with a 'misleading' label and blocked any ability to like or share the tweet".

- On December 11th 2020, the same day that Pfizer's COVID-19 vaccine received emergency use authorisation from the FDA, a Zoom calendar appointment entitled "Vaccine Disinformation Response" invited personnel at the Department of Health and Human Services, Pfizer and other pharmaceutical companies and Stanford University to discuss "a coalition to respond to COVID-19 vaccine disinformation".

- Shortly after the December 11th 2020 meeting, Stanford University co-launched the Virality Project. For at least the next year, Stanford and members of the Virality Project pressured social media companies to conceal and suppress information about Pfizer's COVID-19 vaccine, including information about safety and efficacy.
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