We are late to turn to a critical document obtained by FOIA by the Public Health and Medical Professionals for Transparency Documents. Called 5.3.6 Cumulative analysis of post-authorization adverse event reports of pf-07302048 (bnt162b2) received through 28-feb-2021. The publication of what ought to be regarded as an explosive revelation of the range and frequency of its Covid vaccine side effects has gotten barely any notice, even on Twitter. We’ve posted the document in full at the end of this post for your inspection.
Unfortunately, it’s impossible to reach any definitive conclusions about this information because it isn’t a Phase IV clinical trial, where participants trials are tracked to capture any adverse effects that occur over an intermediate period of time. Instead, this report is based on a hodge-podge of voluntary reports into various systems across 63 countries, with the overwhelming majority coming from the US and UK, from December 1, 2020 through February 28, 2021. I find putting the start as of December 1 misleading, since the first shots in the US were administered starting December 14, 2020. So you wouldn’t even start to see what happens after a full two-shot regime until end of December, which means this is effectively two, not three, months of data
Aside from side effect information not being gathered systematically and to a consistent standard, an even bigger problem is the lack of data about the denominator, the number and mix of vaccinated subjects. The lack of information about the underlying population means it’s impossible to determine the rate of these side effects. Recall that the initial rollout gave priority to the elderly, to at risk groups, and to medical workers. One of the things you’ll notice right away is that the side effects are far more common among women:
The fact that the reports don’t even capture the gender of 7% of the respondents tells you how casual and haphazard an exercise this was. Even so, at least 71% of the total is female. Is this because the underlying population was heavily female due to overrepresenting the aged (women live longer than men) and medical workers (nursing and housekeeping staff are typically women and outnumber doctors, who skew male)? Or because one of the common side effects is the triggering or intensification of autoimmune diseases, and women are more prone to them? Or both?
However, some who took an early look at the document discredited themselves by not bothering to understand its huge limits, and naively or disingenuously making claims about supposedly horribly high levels of bad outcomes among pregnant women, when there was no information whatsoever about how many pregnant women were vaccinated. Without that number, you can’t determine if those results were any worse than for a control of unvaccinated pregnant women.
Due to this document being released pursuant to the Emergency Use Authorization, as opposed to a typical drug approval process, I’m not sure what if any standards governed its production. Readers who know the ins and outs of FDA regulations are very much encouraged to pipe up. The commentary from Reuters at the end of January wasn’t terribly enlightening:
The document was submitted by Pfizer-BioNTech as part of its Biological License Application (BLA) to the U.S. Federal Drug Administration (FDA), Alison Hunt, an FDA Press Officer told Reuters via email.
The BLA is a request for permission to introduce or distribute a new biologic product across states ( here ). The FDA reviews the information in the BLA “to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.” ( here )
This large number of reports comes despite the fact that, as Pfizer blandly warns using boilerplate language, the number of side effects is almost certainly understated:
Reports are submitted voluntarily, and the magnitude of underreporting is unknown…
Among adverse event reports received into the Pfizer safety database during the cumulative period, only those having a complete workflow cycle in the safety database (meaning they progressed to Distribution or Closed workflow status) are included in the monthly SMSR. This approach prevents the inclusion of cases that are not fully processed hence not accurately reflecting final information. Due to the large numbers of spontaneous adverse event reports received for the product, the MAH 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. The increased volume of reports has not impacted case processing for serious reports, and compliance metrics continue to be monitored weekly with prompt action taken as needed to maintain compliance with expedited reporting obligations.
Pfizer also points out that the reporting of an adverse event does not establish causality, as in that the jab was necessarily responsible.
Nevertheless, as IM Doc said:
This is a post marketing document.
in normal times, this would be in the Phase IV period. I have no idea how this is done for an EUA.
These are apparently side effects reported after the vaccines were rolled out.
No wonder they wanted to bury this.
OMG even my cynical self is whomperjawed. I have quite frankly never seen anything like this in all my years of IRB [Institutional Review Board] work. This is absolutely unprecedented.
Please look at starting at page 30. The list is overwhelming. Something about this tells me someone should be going to jail.
It is vindication for all the months I have been questioning my sanity. Having these happening to patients all the while the media and colleagues screaming about 100% safety. This is not the vindication I wanted though. This is just plain sad.
To provide further evidence that the adverse events are undercounted, menstrual period irregularities and post menopausal bleeding are not listed. The only female reproductive plumbing issue listed is “premature menopause”. Doctors tend to downplay menstrual cycle issues, since they can be affected by stress, weight loss, and intense exercise. But a subset of women is hyper regular and changes tell them something is amiss. Other I know first or second hand report extreme change, such as going from four to five days of flow to only one and remaining there.
Even though female non-fertility is treated less seriously that female fertility, period/bleeding among menopausal women is particularly troubling, since it can be a sign of cancer. I’ve had that side effect, three times, along with PMS bloating worse than I ever had in my youth. My sonogram at the top lists the bleeding as triggered by the vaccine, which means is it considered uncontroversial in NYC to link the vaccines to the resumption of periods. My doctor was sufficiently alarmed that she wanted me scraped out pronto. So I am having to have a medical procedure due to having gotten a jab. Yet if I understand Pfizer’s categorization correctly, they would deem a case like mine to be “non-serious”.
It’s bad enough to see a significant category of side effects omitted. But on top of that, no one is tracking whether cases Covid-vaccine-induced post-menopausal bleeding have a higher incidence of cancer than typical instances of post-menopausal bleeding bleeding.
More from IM Doc:
I want to explain the “appendix 1” starting on page 30.
There is always an “appendix 1” in these reports.
It is a comprehensive list of the ASE (Adverse side effects) that are especially attuned in the study. In general, it is a list of all the things that came up in the animal studies and the Phase 1-3 trials in humans. It is an index of the things that they were to keep a close eye on.
In general, this list in most documents like this I have ever seen is 2-3 maybe 4 pages long – NOT 10.
That is what so bowled me over this AM.
I can think of 2 possible things going on here –
1) The list of ASE from the previous phases of research really are this overwhelming.
2) Pfizer knew they had lots of side effects and just wanted “to put it all out there” in an attempt to cover their ass. They may have done this because of the warp speed emergency manner in which this was done – ie – we have not had time to fully assess risk – therefore we are going to just be a sponge and take in everything.
There may be other reasons I have not thought of. Whatever the case – I have never seen anything like this in my life.
But the really damning parts are these tables – where very elevated numbers of patients are having these problems.
I have seen any number of CHEMOTHERAPY agents with less problems than this in my life.
And we have to weigh risk and benefits even in these trials. If for example a novel CHEMO agent was saving 30% but killing 5% – it would likely be approved with LARGE BLACK BOX WARNINGS.
This agent – however – is not chemotherapy. It is a vaccine to be given out to everyone. It has been screamed from the rooftops for the people to hear that it was 100% safe. Any and all discussion in the media and social media of any problems has been squelched and those stating these things called quacks. It had a benefit of an absolute risk reduction of infection of 0.2%. And here we are with all these side effects. In huge numbers. Even more concerning – is two-six months of benefit worth all of these risks? I think not.
My question would be – when did the FDA and CDC and CEOs and media people know this information? How can anyone at FDA or the White House think it was a good idea for nationwide mandates – with this kind of problem?
This is very very troubling Someone must be held to account.
But Pfizer remains a big winner. The Biden administration is determined to move on from Covid, as if Covid doesn’t have a say. And Ukraine is a huge aid in diverting attention from the ongoing pandemic.00 Pfizer Covid Vaccine post marketing report