The FDA Knew the Potential Adverse Risks
​Prior to Vaccine Rollout  

​In October 2020, the FDA gave a presentation to the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The title of the presentation is “CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness”. (CBER is the Center for Biologics Evaluation & Research in the FDA.)
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As indicated in the presentation, the passive surveillance plan was to monitor safety in the Vaccine Adverse Event Reporting System (VAERS), of which the FDA and CDC share management. The FDA said their efforts would include:
  • “FDA and CDC have weekly and bi-weekly coordination meetings on VAERS...
  • CBER DE Physicians will be reviewing the serious adverse event reports
  • FDA will utilize statistical data-mining methods to detect disproportional reporting of specific vaccine-adverse event combinations to identify AEs that are more frequently reported”
They also reference an active surveillance plan ​composed of systems called “BEST” and ‘CMS Partnership” that the FDA own. These include several partnerships with​
healthcare consortiums that provide data from inpatient, outpatient, and emergency department settings.  The CMS partnership provides Medicare and MedicAid data.  Later they mention that there will be “Rapid data access for near real time surveillance”. 

The Most Telling Slide in this presentation from the FDA to the VRBPAC is shown below.  They listed the potential side effects from the COVID vaccines in October 2020.  These vaccines came out to the public in December 2020. 
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WERE YOU INFORMED OF THESE POTENTIAL ADVERSE EVENT OUTCOMES?

Many of these side effects match exactly the adverse events that are indeed captured in the VAERS system and that citizens around the world are experiencing.  (More on this will be shown throughout this newsletter)

The full presentation can be viewed at: https://www.fda.gov/media/143557/download
Slide 16 of the October 22, 2020 FDA presentation showing potential adverse side effects of COVID-19 vaccines

Were you informed of these "possible adverse event outcomes" when you received your COVID vaccines?

What the Original Pfizer Study Showed  

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  • No all-cause morbidity or mortality benefit
  • Four times the number of cardiac arrest deaths than the placebo group (See chart to the right)
  • Drug possibly saved 1 life per 22,000 recipients (so if vaccinate 220 million people, you may save 10,000 lives from COVID) - However, death toll in VAERS is over 30,000 currently, so the “cure” is worse than the disease. (More on VAERS later)
  • Pregnant and lactating women were excluded from the trial (no effects in that population were studied)

​The benefit from this vaccine should be obvious to warrant mass-vaccination rollout. It is not. The safety from the vaccine MUST be obvious before ever considering mandating the vaccines for school, work, or any other condition. The safety was not obvious. In fact, the study shows that cardiac events should have been flagged as needing more review/understanding.

Links to the original study: https://www.nejm.org/doi/full/10.1056/nejmoa2110345

Supplemental Appendix: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf
More cardiac events in the Pfizer-injected group than in the placebo group 
Table from Page 12 of the Supplementary Appendix of the Pfizer Study.  Note the increase in cardiac deaths in injected versus placebo groups

​Pfizer Needed to Hire More Staff to Process ​Adverse Events Spring 2021  


​In a Pfizer document “5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021”, it states:
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“Due to the large numbers of spontaneous adverse event reports received for the product, the MAH (marketing authorization holder) 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……… 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 __additional fulltime employees (FTEs). More are joining each month with an expected total of more than __additional resources by the end of June 2021.”

Note: Appendix 1 in this document lists 9 full pages of adverse events. Also, the document leaves out how many additional employees and additional resources were added.



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​Other Items Discovered in Released Pfizer Documents  

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​Their study on 1,000 kids minimized at least one teenager’s side effects in the trial. Maddie deGaray is paralyzed and now has a feeding tube yet Pfizer classified her side effect as “mild abdominal pain”. (There is a court case ongoing related to allegations of fraud by Pfizer in their studies)

In Pfizer’s Post-Authorization of Adverse Event Reports through 2/28/21, Pfizer reviewed 270 pregnancies with adverse events:
  • 32 pregnancy cases listed an outcome of an adverse event
  • 238 pregnancies did not have an outcome listed to decipher the outcome.
  • 26 of 32 cases with outcome resulted in spontaneous abortions
  • Yet, Pfizer states: “Conclusion: There were no safety signals that emerged from the review of these cases of use in pregnancy and while breast feeding.”