FDA Report Suggests All-Cause Mortality 24% Higher Among Vaccinated
A report released by the Food and Drug Administration (FDA) to provide information on the agency’s decision in August to grant full approval to the Pfizer-BioNTech COVID vaccine shows the total number of deaths reported in the clinical trial’s vaccinated group was 24 percent higher than those in the placebo group, which did not receive the vaccine.
FDA declared in its report, “None of the deaths were considered related to vaccination.”
With about 22,000 clinical trial participants in each group, the Pfizer data, released in July, showed near-equal all-cause mortality between the vaccine and placebo, or control, groups, six months after testing was performed, Israel National News reported November 17.
Pfizer reported 15 deaths among the vaccinated, while 14 deaths were noted among the placebo participants. Of these 29 deaths, Pfizer said one in the vaccinated group and two in the placebo group were related to the coronavirus.
The FDA report, however, provided more comprehensive information, revealing 17 deaths among those in the control group and 21 in the vaccinated group, the difference in all-cause deaths amounting to about 24 percent.
Israel National News reported:
[T]he FDA justifying its August 2021 approval for the vaccine did not find a link between the vaccine and increased mortality risk, noting that the majority of side-effects, and all common side effects (any reported by more than 10% of recipients) were mild, ranging from fatigue and headache to muscle pain, chills, joint pain, fever, and swelling.
Though the FDA noted 103 serious adverse events in the vaccine group and 117 in the placebo group, “a break-down and comparison of serious adverse events was not provided,” the news report noted.
The FDA also stated in its report it found “no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship” to the vaccine.
Nevertheless, FDA did report that, following the issuance of the Pfizer vaccine’s Emergency Use Authorization (EUA) in December 2020, “FDA and CDC identified serious risks for myocarditis and pericarditis following administration” of the vaccine.
The risk factor appears to be higher in males under 40, FDA added, with boys aged 12 to 17 especially at risk.
In August, investigative journalist and author of Pandemia: How Coronavirus Hysteria Took Over Our Government, Rights, and Lives (to be released November 30), Alex Berenson wrote at his Substack column that his report on the Pfizer data ultimately led Twitter to permanently ban him from its platform.
Berenson wrote Pfizer’s updated results of its vaccine clinical trial “is the final clean update we will ever have on the vaccine’s safety and efficacy”:
Unless Pfizer is convinced or forced to run another big trial, we will never again have the chance to compare how a large group of people who received the vaccine fared against a matched group who instead received a placebo (no treatment).
“Pfizer is responsible for the fact we won’t have good updated data going forward,” Berenson wrote. “It destroyed the chance for longer-term results by offering the vaccine to people who had received the placebo in the trial only days after regulators authorized its use.”
Berenson referred us to Matthew Herper, writing at STAT in January, who provided further details about Pfizer’s decision to offer its COVID vaccine to any clinical trial volunteer in the placebo group by March 1 – months earlier than originally planned.
Herper explained the significance of the pharm giant’s choice:
The decision represents the conclusion of a complex and public kabuki dance between the Food and Drug Administration, Pfizer, and vaccine volunteers, as well as with Moderna, which developed its own Covid-19 vaccine. The FDA and its advisers pushed hard for volunteers to remain on placebo as long as possible to gather more safety and efficacy data about the vaccines, while the companies argued volunteers should receive the vaccines sooner for both ethical and practical reasons.
On Friday, Joe Martino of The Pulse questioned whether the FDA report did, in fact, find all-cause mortality is higher among the vaccinated.
“The claim is that the rate of all cause mortality is significantly higher in the vaccinated group, yet the trial doesn’t illustrate this,” he asserted, explaining further:
That said, we must understand that Pfizer’s trial was not powerful enough to pick up on widescale issues as it was small and short. Further, we are still seeing strong signals of vaccine injury in the real world data, and we cannot look to Pfizer’s trial to understand it.
Once Pfizer offered all placebo group individuals the vaccine, Martino wrote, “it effectively killed any chance of seeing long term issues with vaccination as the trial was now over.”
“But since Pfizer ended the trials so quickly, we now have no choice but to look at numbers in reporting systems like VAERS, of the UK’s Yellow Card system,” he concluded:
We’re seeing an unexpectedly high rate of death and severe injury from COVID vaccines. Not to mention that many observations made by doctors within their case loads are indicating more injury than expected.
In a powerful address in Milan, Italy, earlier this month to a crowd of protesters denouncing government-imposed vaccine mandates, Robert F. Kennedy, Jr., founder of Children’s Health Defense, told his listeners, “I’m going to talk about the vaccine.”
“People say I’m against vaccines,” said Kennedy, the author of The Real Anthony Fauci. “I’m not against vaccines. I’m only against bad vaccines.”
In fact, leftwing Wikipedia names Kennedy’s “occupation” as “anti-vaccine activist, conspiracy theorist, author, environmental lawyer.”
“And I’m not gonna tell you what Robert Kennedy thinks; I’m going to tell you what Pfizer told United States FDA,” he said, going on to explain why he believes Pfizer cut short its clinical trial:
Pfizer is the only company that has an approved vaccine in the United States, and Pfizer was supposed to have a three-year study. But they cut it to six months. And then they gave vaccinations to all the controls. Why did they do that? Why did they end the study in six months? Because they learned that the antibodies disappear in six months, and the vaccine no longer provides protection. So, they had to end it in six months. They could not do what they planned – three years. Then, they took all of their records for that six months and they gave them to FDA. The most important table is the table that tells you all-cause mortality: how many people died in the vaccine group, how many died in the placebo group, during that six month period …
Here’s what the numbers say. There were 22,000 people in the vaccine group. Over six months, one died from COVID. In the placebo group, the control group, there were 22,000 people, two died from COVID, in six months. That allowed Pfizer to tell the American public that the vaccine is 100% effective, because two is 100% of one. Most Americans, most Italians, when they hear that the vaccine is 100% effective, what they think is that if I take the vaccine, I have 100% chance of not dying from COVID. That’s not what it means. What it means is they have to give 22,000 vaccines to protect one person from dying from COVID. What that means is they better make sure that the vaccine itself does not kill one person even, because if it kills one person, then you cancel out the entire benefit.
Reactions to the FDA report suggesting all-cause mortality is 24 percent higher in the vaccinated come as the World Health Organization (WHO) announced Friday it had classified a new COVID strain, considered to be a “variant of concern,” and labeled it as “Omicron.”
Dr. Tedros Adhanom Ghebreyesus, WHO director-general, stated on Twitter Friday that since “Omicron” has a “large number of mutations, some of which are concerning … we need to speed up our efforts to deliver on #VaccinEquity ASAP and protect the most vulnerable everywhere.”
In other words, WHO wants more of those people the left considers to be victims of “inequity” to be vaccinated.
Earlier in his speech in Milan, Kennedy condemned the vaccination mandates as nothing less than a world-wide “coup d’état”:
The green pass is how they consolidate their power over your lives. A green pass is not a public health measure. It is a tool for totalitarian control of your transportation, your bank account, your movements, every aspect of your life. And this is not a new idea. This is the same idea that they used in Germany in 1937. They issued a pass for people that they wanted to control.
When the South African apartheid government wanted to control the black population of South Africa, what was the most important thing they did? They issued a green pass.
“I want you to ask all the people in the journalism press who are here today, if the green pass is about public health, why is it being issued not by the Health Ministry?” Kennedy asserted. “It’s being issued by the Financial Ministry. Do they think that we are stupid?”
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