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- People ages 65 and older who received Pfizer's updated (bivalent) COVID-19 booster shot may be at increased risk of stroke
- The CDC's Vaccine Safety Datalink (VSD) flagged the potential safety issue, revealing that those 65 and over were more likely to have an ischemic stroke 21 days after receiving Pfizer's bivalent COVID-19 shot compared to 22 to 44 days later
- In their announcement, the CDC and the FDA downplayed the VSD safety signal while encouraging everyone eligible to continue to get the shots
- According to Dr. Meryl Nass, the fact that VSD produced a red flag is evidence that the problem is likely much worse than health agencies are letting on
- While the health agencies stressed that no other safety systems, such as the Vaccine Adverse Event Reporting System (VAERS), had flagged a stroke risk, the CDC admitted in a FOIA request that ischemic stroke triggered a safety signal in VAERS
People ages 65 and older who received Pfizer's updated (bivalent) COVID-19 booster shot may be at increased risk of stroke, according to an announcement made by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration.1
The joint statement warns that the CDC's Vaccine Safety Datalink (VSD), which uses near real-time surveillance to track vaccine safety, flagged the potential safety issue, revealing that those 65 and over were more likely to have an ischemic stroke 21 days after receiving Pfizer's bivalent COVID-19 shot compared to 22 to 44 days later.2
US Health Agencies Downplay Stroke Risk
In their announcement, the CDC and the FDA made light of the VSD safety signal, stating within the first two paragraphs, "Often these safety systems detect signals that could be due to factors other than the vaccine itself. All signals require further investigation and confirmation from formal epidemiologic studies."3
They frame the message as though they're doing their duty to be transparent and open with the public regarding risks attached to COVID-19 shots. But most of the announcement details reasons why they believe you should still get boosted, no matter your age:4
"Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems …
No change in vaccination practice is recommended. CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine."
Updated Boosters Likely Causing a 'Great Deal of Strokes'
According to Dr. Meryl Nass, a board-certified internal medicine physician with special expertise in vaccine safety and vaccine mandates, the fact that VSD produced a red flag is evidence that the problem is likely much worse than health agencies are letting on.
Not to mention, the FDA and CDC released the statement on a Friday night before a three-day weekend, "which is proof they wanted to bury it," Nass said. Even Florida Surgeon General Dr. Joseph Ladapo tweeted about the odd timing:5,6
"What better time than a Friday afternoon for @CDCgov and @US_FDA to let Americans know that the mRNA shots they've been pushing may be causing strokes? Don't worry, we'll make sure the word gets out — just like we've been doing for months."
"This is huge news, because the VSD database that produced the red flag for ischemic strokes (which comprise 80% of all strokes and are due to blood clots) has been analyzed by CDC in a manner that prevented it from showing red flags in the past. No red flag from myocarditis, heart attacks, sudden deaths, Bell's palsy, etc.
In other words, they are using a bum algorithm or method that is designed to miss adverse event signals. Eventually CDC stumbled on a myocarditis signal in this database, but missed all the other obvious diagnoses. So if they are using the same crude technique and found strokes, that means there were a great deal of strokes, many more than would have been expected as the baseline rate.
Furthermore, the VSD is considered an active surveillance database of high reliability, which includes the medical records of 12 million Americans. This announcement probably means that not only are the bivalent vaccines worthless, but they are also considerably more harmful than the earlier, monovalent vaccines."
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Concerns About Updated Boosters From the Start
The COVID-19 booster shots that generated the VSD safety signal for stroke are known as bivalent shots, or "updated boosters." August 31, 2022, the FDA amended the emergency use authorizations (EUAs) of Moderna and Pfizer's COVID-19 shots to authorize bivalent formulations to be used as booster doses at least two months after a previous booster or primary series of the shots.
"The bivalent vaccines, which we will also refer to as "updated boosters," contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2," the FDA stated.8
Yet, in June 2022, before the shots were even approved, the U.S. Department of Health and Human Services announced that it, in partnership with the Department of Defense, had already agreed to purchase 105 million doses of Pfizer's new COVID-19 shot — for $3.2 billion.9
The contract was intended to supply booster shots for the fall 2022 injection campaign and included options to purchase up to 300 million doses. The decision came after a June 28 meeting of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), which recommended that an omicron-specific component be included in COVID-19 booster shots in the U.S.10
While Pfizer cited strong antibody responses from its retooled boosters, the booster shot studies did not reveal whether the shots prevent COVID-19 cases or how long they are effective.11
Further, human data are only available for Pfizer's boosters targeting BA.1; only animal data are available for the BA.4/BA.5 boosters that rolled out September 2022.12 John Moore, professor of microbiology and immunology at Weill Cornell Medicine, told NPR, "For the FDA to rely on mouse data is just bizarre, in my opinion. Mouse data are not going to be predictive in any way of what you would see in humans."13 Nass added:14
"This is the fastest rollout of a new vaccine in world history. How did it happen? Instead of this being a tale of human grit and ingenuity, it is a tale of human weakness and recklessness. Let me ask again: how did such a rapid vaccine rollout occur?
It occurred the only way it could possibly occur: by bending the rules, creating a new regulatory playbook and failing to obtain any human data for the new vaccines. The manufacturers did not have to go through months-long trials, and FDA did not have to pour over any human trial data, because there weren't any. Let that sink in: the new BA.4/5 bivalent vaccines have only been tested in mice, not humans."
'CDC Is Lying to People … Stroke Risk Is Very Real'
Steve Kirsch, executive director of the Vaccine Safety Research Foundation, also spoke out regarding CDC's and FDA's stroke risk announcement. While the health agencies stressed that no other safety systems, such as the Vaccine Adverse Event Reporting System (VAERS) or Pfizer-BioNTech's global safety database, had flagged a stroke risk, Kirsch says this is a lie.
In fact, Kirsch states that the CDC admitted in a FOIA request that ischemic stroke triggered a safety signal in VAERS. If they were honest with the U.S. public, he notes, they would say:15
"OK, to be perfectly honest, we KNOW that the shot is causing strokes. In fact, there's a safety signal for stroke in all the databases, but we're just too darn corrupt to admit that and the mainstream press is too ignorant to ask us about it. So we lied. And we get away with it. Always."
A spreadsheet obtained from the CDC under FOIA revealed 770 safety signals triggered in VAERS due to COVID-19 shots, including death, ischemic stroke, cardiac arrest, pulmonary thrombosis, Bell's palsy, heart attack, deep vein thrombosis and more.16 Again, CDC and FDA's announcement makes it sound like the safety signal is nothing to worry about. But if they were telling the truth, their warning would sound more like this, Kirsch states:17
"It's a real safety signal of course. These shots are a disaster and nobody in the mainstream medical community has time to check out the data directly. We control the journals and we make sure that nothing gets published that goes against the narrative, so the medical community gets fooled.
Those who actually check out the data or talk to large geriatric practices or nursing homes and find out the truth are too afraid to speak out because they know they will lose their job, their hospital privileges, their NIH funding, and their license to practice medicine.
But most never get that far since we train them in medical school that vaccines are always safe and to always trust authority. That's why most of the physicians think the vaccines are on the level. They do what they are told."
Even Paul Offit Is Bashing Bivalent COVID Shots
When even vaccination proponent Dr. Paul Offit, director of the vaccine education center at Children's Hospital of Philadelphia, issues a "cautionary tale" about a shot, you know it's got to be bad. Writing in The New England Journal of Medicine, Offit notes that he's a member of VRBPAC and sat in on the June 28, 2022 presentation, when Pfizer and Moderna presented data on their bivalent shots:18
"The results were underwhelming. Bivalent boosters resulted in levels of neutralizing antibodies against BA.1 that were only 1.5 to 1.75 times as high as those achieved with monovalent boosters. Previous experience with the companies' vaccines suggested that this difference was unlikely to be clinically significant."
Despite this, the FDA advisory committee voted in favor of authorizing the shots, since they would be targeting omicron subvariants BA.4 and BA.5. "A series of rapid-fire policy decisions followed," Offit explains, such that, less than four months after the advisory meeting, the CDC had recommended bivalent boosters for everyone 5 years of age and older.
"At that point, no data from humans, including immunogenicity data, were available for comparing the relative capacities of the monovalent and bivalent vaccines to protect against BA.4 and BA.5," he says.19 Soon, however, data rolled in showing the bivalent boosters did not offer better protection than the former COVID-19 booster shots,20 which were already failing.21 Offit says the bivalent boosters likely failed due to imprinting:22
"The immune systems of people immunized with the bivalent vaccine, all of whom had previously been vaccinated, were primed to respond to the ancestral strain of SARS-CoV-2. They therefore probably responded to epitopes shared by BA.4 and BA.5 and the ancestral strain, rather than to new epitopes on BA.4 and BA.5."
Even in reference to a CDC study23 that found the bivalent shots resulted in anywhere from 28% to 56% extra protection, depending on how long ago their last COVID-19 shot was, Offit says, "Given the results of previous studies, it's likely that this moderate increase in protection against probably generally mild disease will be short lived."24
Adding insult to injury, the COVID strains the bivalent shots target have largely disappeared. "By December 2022, the BA.4 strain was no longer circulating, and BA.5 accounted for less than 25% of circulating SARS-CoV-2 strains," Offit says.25
At this point, Kirsch summed up, the data is crystal clear that boosters aren't working and are dangerous. "Paul Offit is no dummy; he's not getting any more boosters," he says. "Neither should you."26