Pfizer gave itself a high threshold for acceptable levels of myocarditis cases following COVID-19 vaccination until findings in Israel forced the US Food and Drug Administration to notice, a recent investigation alleges.Joyce Allen and Linnea Wahl released the findings in Report 97 for the DailyClout. The publication joined forces with The War Room to secure the court-ordered release of thousands of pages of documents the FDA used in its approval and regulation of COVID-19 vaccines."These approvals came despite the fact that FDA officials had reviewed and signed off on data proving that Pfizer’s mRNA drug was dangerous, especially to young men and boys. Did FDA employees miss important safety signals?" the authors asked.In spring 2021, the FDA granted emergency use authorization for the Pfizer mRNA COVID-19 vaccine to be given to children older than 12 and renewed its approval for use in adults despite signs they should not.From December 2020 until September 2021, Pfizer collected data on the safety of its mRNA COVID-19 drug and submitted monthly summaries to the FDA. FDA employees, reviewed the data summaries and filled out checklists documenting their reviews. Checklists from March through August 2021 have been released.Employees charged with doing the checklists included physician Dr. Deborah L. Thompson, biochemist Ramachandra Naik, and regulatory information specialist Laura Gottschalk.Each month, Thompson marked "yes" to the question: “Have there been any new safety issues identified by the reviewer in this PSUR (periodic safety update report)?” To this, she regurgitated the text of Pfizer's summaries and concluded, “the contents... do not indicate a need for further regulatory action,” with either Naik or Gottschalk signing off.Finally, in May 2021, Thompson noted that myocarditis could be a safety issue for young men receiving the mRNA COVID-19 drug. The condition leaves heart muscles weakened due to inflammation.Safety signals are often triggered by an observed-to-expected (O/E) ratio of greater than one where the number of people who get the condition after the intervention is greater than what would normally be expected in the general population.In December 2020, European researchers published expected O/E values for myocarditis based on ten European healthcare databases. However, from January through April 2021, Pfizer cherry-picked a value from Sweden published in 2007, which was much higher.From January through May, Pfizer submitted the myocarditis incidents as an overall number, not distinguishing between age and sex. By May, Pfizer used a value from Italy which was twice as high as the Swedish value.Thompson finally noted in her checklist that the “background (expected) rates used in your (Pfizer’s) O/E analysis are relatively high for myocarditis.”The DailyClout authors wondered what took so long."What prompted Dr. Thompson to finally notice Pfizer’s potential data manipulation? Perhaps it was Israeli researchers’ announcement in April 2021 that myocarditis was increased in young men who received Pfizer’s mRNA COVID-19 shot," they wrote."Yet it was not until late in June 2021 that FDA added a myocarditis warning to Pfizer’s patient fact sheet.The FDA website insists, "The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines."However, the DailyClout authors wrote, "Clearly, the FDA employees with 'globally recognized expertise' missed a critical safety signal."Thompson made an assessment of Pfizer's pharmacovigilance plan dated May 18, 2021 in the document, even though it included a scan for reports made June 23. Key words included "autoimmune myocarditis, autoimmune pericarditis, eosinophilic myocarditis, hypersensitivity myocarditis, myocarditis, pericarditis, pericarditis adhesive, pericarditis constrictive, and pleuropericarditis. The query returned 1,023 reports (1,012 US reports), including 809 serious reports (seven were death reports concerning six unique individuals), of which 652 reports were in individuals under 30 years of age.Thompson acknowledged a new safety signal but did not recommend that the vaccine have any risk evaluation and mitigation strategies.“At this time, the available safety data do not suggest a safety concern that would require a REMS," she wrote.Health Canada acknowledges the condition is a "rare" consequence for some COVID-19 vaccine recipients and writes, "Myocarditis and pericarditis seem to occur more often in some populations and situations, such as:in adolescents and young adultsin malesfollowing the second dosetypically occurring within 7 days after vaccination."In the majority of cases, symptoms of myocarditis or pericarditis resolve quickly after seeking medical care."
Pfizer gave itself a high threshold for acceptable levels of myocarditis cases following COVID-19 vaccination until findings in Israel forced the US Food and Drug Administration to notice, a recent investigation alleges.Joyce Allen and Linnea Wahl released the findings in Report 97 for the DailyClout. The publication joined forces with The War Room to secure the court-ordered release of thousands of pages of documents the FDA used in its approval and regulation of COVID-19 vaccines."These approvals came despite the fact that FDA officials had reviewed and signed off on data proving that Pfizer’s mRNA drug was dangerous, especially to young men and boys. Did FDA employees miss important safety signals?" the authors asked.In spring 2021, the FDA granted emergency use authorization for the Pfizer mRNA COVID-19 vaccine to be given to children older than 12 and renewed its approval for use in adults despite signs they should not.From December 2020 until September 2021, Pfizer collected data on the safety of its mRNA COVID-19 drug and submitted monthly summaries to the FDA. FDA employees, reviewed the data summaries and filled out checklists documenting their reviews. Checklists from March through August 2021 have been released.Employees charged with doing the checklists included physician Dr. Deborah L. Thompson, biochemist Ramachandra Naik, and regulatory information specialist Laura Gottschalk.Each month, Thompson marked "yes" to the question: “Have there been any new safety issues identified by the reviewer in this PSUR (periodic safety update report)?” To this, she regurgitated the text of Pfizer's summaries and concluded, “the contents... do not indicate a need for further regulatory action,” with either Naik or Gottschalk signing off.Finally, in May 2021, Thompson noted that myocarditis could be a safety issue for young men receiving the mRNA COVID-19 drug. The condition leaves heart muscles weakened due to inflammation.Safety signals are often triggered by an observed-to-expected (O/E) ratio of greater than one where the number of people who get the condition after the intervention is greater than what would normally be expected in the general population.In December 2020, European researchers published expected O/E values for myocarditis based on ten European healthcare databases. However, from January through April 2021, Pfizer cherry-picked a value from Sweden published in 2007, which was much higher.From January through May, Pfizer submitted the myocarditis incidents as an overall number, not distinguishing between age and sex. By May, Pfizer used a value from Italy which was twice as high as the Swedish value.Thompson finally noted in her checklist that the “background (expected) rates used in your (Pfizer’s) O/E analysis are relatively high for myocarditis.”The DailyClout authors wondered what took so long."What prompted Dr. Thompson to finally notice Pfizer’s potential data manipulation? Perhaps it was Israeli researchers’ announcement in April 2021 that myocarditis was increased in young men who received Pfizer’s mRNA COVID-19 shot," they wrote."Yet it was not until late in June 2021 that FDA added a myocarditis warning to Pfizer’s patient fact sheet.The FDA website insists, "The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines."However, the DailyClout authors wrote, "Clearly, the FDA employees with 'globally recognized expertise' missed a critical safety signal."Thompson made an assessment of Pfizer's pharmacovigilance plan dated May 18, 2021 in the document, even though it included a scan for reports made June 23. Key words included "autoimmune myocarditis, autoimmune pericarditis, eosinophilic myocarditis, hypersensitivity myocarditis, myocarditis, pericarditis, pericarditis adhesive, pericarditis constrictive, and pleuropericarditis. The query returned 1,023 reports (1,012 US reports), including 809 serious reports (seven were death reports concerning six unique individuals), of which 652 reports were in individuals under 30 years of age.Thompson acknowledged a new safety signal but did not recommend that the vaccine have any risk evaluation and mitigation strategies.“At this time, the available safety data do not suggest a safety concern that would require a REMS," she wrote.Health Canada acknowledges the condition is a "rare" consequence for some COVID-19 vaccine recipients and writes, "Myocarditis and pericarditis seem to occur more often in some populations and situations, such as:in adolescents and young adultsin malesfollowing the second dosetypically occurring within 7 days after vaccination."In the majority of cases, symptoms of myocarditis or pericarditis resolve quickly after seeking medical care."
