Pfizerleaks: Adverse events and biodistribution of the mRNA injection
Among the large and growing community of people concerned about the “safe and effective” COVID-19 vaccines, Public Health and Medical Professionals for Transparency came together “to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines”. The group recently obtained a court decision that forces the Food & Drug Administration (FDA) to release Pfizer’s licensing application documents. The judge ordered an expedited release against dogged pushback from the corporation and the agency; their unprecedented attempt to delay the disclosure by more than half a century is why I titled this post “Pfizerleaks”.
A set of 125 documents was released via PHMPT’s web site on March 1st, 2022. In the context of this release, one document, “5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT—REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021” (available for download under file name “5.3.6-postmarketing-experience.pdf”) has drawn a lot of attention, yet it had already been published on November 17, 2021, as part of the very first release documented by the lawyer of the PHMPT group, Aaron Siri. The postmarketing document had previously been discussed by critics of the mainstream narrative and has recently been misinterpreted in at least one aspect.
The report covers the period of December 1, 2020, to February 28, 2021. During this time early in the global COVID-19 vaccination campaign, Pfizer collected 42,086 adverse event reports from 63 countries around the globe. Reports are unsolicited (i.e., voluntary) and Pfizer seems to assume that underreporting exists when they dryly state that “the magnitude of underreporting is unknown”. The denominator for an incidence calculation—the count of vaccine doses administered during this time frame—has been redacted, additionally limiting the value of the report in terms of assessing vaccine risk. Nevertheless, the raw counts and some patterns in the reported data are informative and hugely concerning.
One of the first shockers is that almost three quarters of the reports are from females; in other words, three times more women reported COVID-19 vaccine adverse events than men. The injections were prioritized for the elderly, but the gender imbalance of the reported side effects cannot be explained by the difference in life expectancy and the greater number of women among the elderly in the population pyramids of many industrialized countries, since those over 75 years of age make up only 12.4% of the submitted reports. The pattern instead points towards a greater susceptibility of women to report-worthy adverse events from the Pfizer product.
According to Figure 1 from the postmarketing document, some 40%-60% of adverse events affecting most body systems are serious; this is consistent with the “red box” summaries in OpenVAERS for domestic (US) adverse event reports, where combinations of the serious outcome categories amount to about 325,000 (42%) out of 780,000 reports as of mid-March 2022.
Among “case outcomes”, Table 1 also reports 1,223 deaths, representing some 3% of all adverse event reports. In their presentation “The Pfizer Inoculations For COVID-19 – More Harm Than Good” (video | pdf) created by mid-December 2021, the Canadian Covid Care Alliance had already noted this outcome among many other issues with the Pfizer vaccine trials and rollout. Yet more concerningly, 9,400 cases in the same table had an “unknown” outcome—quite possibly adding to the death count. The proportion of fatal outcomes among all reports is in the same order of magnitude as in VAERS (about 1.5%) and in Canada’s COVID-19 vaccine safety web site (about 0.75%), both approximately 15 months (February 2022) into the vaccination campaign as compared to three months (February 2021) for the worldwide Pfizer data.
The higher mortality in the Pfizer data may be explained by the time period covering the early vaccination drive during which elderly people were prioritized who had a greater likelihood of dying after injection, whether from or with the vaccine. Other adverse event categories also share similar proportions in terms of orders of magnitude, with some variations that can be explained partially by Canada’s use of AstraZeneca (known to cause TTS/low platelets) and by stricter post-secondary campus mandates in Canada (possibly increasing cardiac issues in young men).
In terms of fatal outcomes, Canada’s flagging pharmacovigilance system is perhaps better understood as a program for the suppression of adverse event reports. In addition to anecdotal evidence of discouraging and denying reports made by health-care professionals, the death count used in the above chart was 304, yet 160 reports among that total “could not be assessed due to insufficient information”; 98 reports “are unlikely linked to a COVID-19 vaccine”; and 46 reports “are still under investigation”. This leaves precisely zero acknowledged COVID-19 vaccine deaths in Canada—a bold claim given the monitoring from elsewhere, heaps of anecdotal evidence, and well-established mechanisms of possible harm.
Previously, e.g. as of 22 October 2021 (report dated 29 October 2021), “6 deaths [that] followed a diagnosis of TTS” were included as a separate category. I did not further investigate, when this was removed and to which of the above categories these six previously confirmed Canadian vaccine deaths have now been added. Maybe a new initiative, the Canadian Adverse Event Reporting System (CAERS), will help to overcome the recklessness of Canadian public health authorities in this respect.
The part of the not-so-new Pfizer postmarketing document that was most discussed on social media was the 9-page appendix listing hundreds of “Adverse Events of Special Interest” (AESI). Many claimed or insinuated that these adverse events had actually been observed during the first phase of the global vaccination campaign, see e.g. Dr. John Campbell’s popular March 9 video “The Pfizer documents” (skip to 13:00 for his astonished reaction to the AESI list). However, based on the wording in the report and elsewhere, these are not adverse events that were actually sustained by Pfizer vaccine recipients but instead they are medical conditions that Pfizer agreed to watch for. For example, Public Health Ontario’s technical brief “Adverse Events of Special Interest (AESIs) for COVID-19 Vaccines Surveillance” explains AESIs as a tool for “enhanced monitoring by pre-specifying events which may otherwise not be captured or readily analyzed from a passive surveillance system”.
Pfizer’s (or rather the FDA’s) March 1st document release includes the file “125742_S1_M2_26_pharmkin-tabulated-summary.pdf”. It tabulates the distribution of the liquid nanoparticles (LNPs) containing the vaccine’s mRNA ingredient across organ systems of the body of lab mice. The information is identical with that received by an international team of researchers from the Japanese public health authorities based on a freedom of information request in May 2021. In a radio interview on May 27, Canadian vaccinologist Dr. Byram Bridle first shared these worrisome news. Ever since, Dr. Bridle has experienced the most harrowing defamation and persecution from colleagues and elements of the general public.
Pharmaceuticals administered into the arm muscle are supposed to slowly leak from the injection site into the body where the immune system responds to the agent. In my chart you can see that the concentration at the injection site is indeed by far the highest (note the logarithmic scale of the y-axis) and stays high over the first two days. The obvious concern though is that noticeable concentrations of LNPs are also found in places like the liver, spleen, adrenal glands (attached to the kidneys), ovaries, and bone marrow. The chart is sorted by the highest concentrations 48 hours after a single injection. Most alarming is the fact that in all of the above organs, the concentration was still rising when Pfizer stopped the experiment (or the reporting on it).
A couple of weeks ago, Dr. Jessica Rose wrote about another Pfizer application document that suggests that biodistribution data for at least nine days after injection existed from an earlier animal tests and why they may have been truncated in the following test. Dr. Rose, an eminently qualified immunologist, molecular biologist and biochemist, also wrote here about the document I discussed in this post.
If we combine the fast and broad distribution of the injected substances in the body with the findings of a new study out of Sweden’s Lund University, concerns about the mRNA vaccines grows further. The researchers found in a lab experiment (“in vitro”) that vaccine mRNA was converted into DNA in human liver cells. Asked about the media attention in their study, Drs. de Marinis and Rasmussen emphasized the preliminary nature of their findings and the urgent need for further study:
We understood that the study would attract attention, but we think it is self-evident that this type of research should be pursued. We have a new vaccine, and it needs to be tested in cell and animal models and also in humans, in various ways. The result might be surprising, but it is also a bit surprising that such studies do not seem to have been carried out before.
So much for the “telescoped” safety trials of the mRNA vaccines supporting trustworthy regulatory approval? In addition, Just the News points out a direct contradiction between the Lund University study results and the CDC’s “Myths and Facts” page, which wrongly claims: “COVID-19 vaccines do not change or interact with your DNA in any way.”
I wrote above that "The denominator for an incidence calculation—the count of vaccine doses administered during this time frame—has been redacted...". Well guess what, with the April 1st document release came a "reissue" of the postmarketing report that specifies the total number of Pfizer/BioNTech doses shipped worldwide at the time the adverse event data collection was completed. The "Naked Emperor" blog has an excellent discussion of this, see https://nakedemperor.substack.com/p/the-missing-number-in-the-pfizer.