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(Brownstone)—This is such a straightforward, open-and-shut case. At least it looks like one to me.
According to Stat News, on May 5, 2022, The J&J adenovirus Covid vaccine “was limited to people 18 and older who cannot take one of the other available vaccines for medical reasons, or who simply will not agree to be vaccinated with one of the messenger RNA vaccines made by Moderna and by Pfizer and its partner BioNTech.”
The reason?
Peter Marks, the FDA’s vaccines lead, told STAT the agency reached its decision after a recent review of the data on the vaccine revealed another person in this country had died after receiving it — the ninth such death — in the first quarter of the year.
[BOLDFACE ADDED]
“If we see deaths and there is an alternative vaccine that is not associated with deaths but is associated with similar efficacy…we felt it was time at this point to make a statement on the [product’s] fact sheet that this was not a first-line vaccine,” said Marks.
With one death for every 2 million doses given in this country, the FDA decided that is a risk most people don’t need to take, Marks said.
Nine deaths.
Compared to “an alternative vaccine that is not associated with deaths” – a statement made on May 5, 2022.
Let’s look at one such “alternative vaccine:”
A document dated FEBRUARY 28, 2021 (almost a whole year BEFORE the Peter Marks statements), recently brought to my attention by a Brownstone reader, presents an analysis of “post-authorization adverse event reports” on the BioNTech/Pfizer Covid vaccine, as requested by the FDA for Pfizer/BioNTech’s Biologics License Application (BLA).
This report, marked “CONFIDENTIAL” but publicly available on phmpt.org, is dated just 3 months after “the first temporary authorisation for emergency supply on 01 December 2020,” which is when the UK gave Emergency Use Authorization to the product.
In the report, we see that there were 1,223 deaths among the 42,086 total cases analyzed in the report. NOTE: the total case number is not the number of people who received the vaccine. It is also not the number of people in a clinical trial. It is the number of adverse event “cases” that were analyzed by Pfizer “on behalf of BioNTech” (aside: the Pfizer-BioNTech relationship is worthy of a lot more analysis than it has received) after the product had been administered internationally for three months.
Over 1,000 deaths in the first three months of administration. The actual number of doses that had been shipped when the report was published is redacted. The number that had been administered up to that date is not reported.
Pfizer’s “DISCUSSION”
The data do not reveal any novel safety concerns or risks requiring label changes and support a favorable benefit risk profile of the BNT162b2 vaccine.
NOTE: I’m guessing that the key word here, for legal purposes, is “novel.” They must have already known about all the adverse events in this report, including death, before the product was authorized and distributed, so technically this report does not include anything “novel,” or new.
Pfizer’s “SUMMARY AND CONCLUSION”
Review of the available data for this cumulative PM experience confirms a favorable benefit: risk balance for BNT162b2.
NOTE: There is no discussion of any benefits in the report.
My Conclusion
Distribution of the J&J shot was limited and the label was changed after NINE associated deaths. The “alternatives” were supposedly “not associated with deaths.” But a report after just 3 months of the initial authorization of one of the two main alternatives shows OVER ONE THOUSAND deaths.
It sure seems like the BioNTech/Pfizer vaccine, for an undisclosed reason, was privileged over the J&J product by regulators, such that even more than 1,000 deaths in three months were not considered a “novel safety concern or risk requiring label changes.” Not to mention withdrawing the product from the market.
My Hypothesis
I believe the BioNTech and Moderna Covid mRNA vaccines were predetermined as the only Covid vaccine products that would be not just aggressively marketed by the public health and regulatory bodies themselves, but also the only products that would remain on the market regardless of any reported adverse events, including thousands of deaths.
The reason for this, I surmise (not enough concrete proof yet to make this a definite claim), is that those two products were designed in tandem by the international biowarfare/biodefense network that ran the entire Covid pandemic and response. The biowarfare network was so hellbent on demonstrating the “safety and efficacy” of its precious mRNA platform that nothing could stand in the way of these products – especially not reports of their total lack of efficacy and jaw-droppingly horrendous safety profile.
Read more about who was in charge of the pandemic response.
Read more about mRNA vaccine products and the biodefense industry.
About the Author
Debbie Lerman, 2023 Brownstone Fellow, has a degree in English from Harvard. She is a retired science writer and a practicing artist in Philadelphia, PA.
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