The FDA Issues Major Warning About Pfizer Drug
The FDA warning comes as vaccine-related fatalities and adverse events come under heightened scrutiny.
The Food and Drug Administration's rushed approval of unproven mRNA therapeutics marketed as "vaccines" has led to critical questioning of how "safe and effective" these drugs truly are.
The highly touted effectiveness of these mRNA therapeutics has been refuted by their inability to substantially lower Covid mortality year-over-year, as well as the persistence of all-cause excess mortality rates, as will be discussed below.
The pharmaceutical companies themselves have essentially admitted defeat by insisting the previously called "fully vaccinated" Americans get a "booster shot," even as many received a regimen of two shots prior.
The incontrovertible evidence is in that "vaccinated" individuals transmit the Delta and Omicron variants readily. It is further demonstration that the "vaccines" are essentially prophylactic therapeutics, as such, only useful for lowering hospitalization and conceivably, mortality rates among at-risk population. They will be called "vaccines" in this article only for reader intelligibility.
However, even the utility of these vaccines* on the issue of lowering excess mortality rates, while causing a grossly underestimated "large number" of serious adverse events, is coming into question.
One thing that should alert Americans right off the bat on this matter is that the CDC and FDA, as well as their corporate media allies, refuse to report anything meaningful about vaccine side effects, except to deny that there is anything worth being concerned about.
Even with massive VAERS undercounting, as we will demonstrate below, the Covid-19 vaccines have led to more reported deaths than all other vaccines combined since 1990.
VAERS summary, which compiles data from the website and presents it in visualization form, reports the number of Adverse Reactions to the vaccines, including deaths.
The VAERS data show 19,249 deaths associated with the vaccines, 30,967 Permanent Disabilities, and 101,315 ER visits. This is more than all other vaccines since 1990 combined. Even so, the VAERS database is far from providing the full picture of the self-reported issues with the Covid-19 "vaccines."
Dr. Jessica Rose, a prominent critic of the universal vaccination agenda, has spoken out forcefully on the issue, only to face censorship in "peer-reviewed journals." She makes an outstanding point that the VAERS system can be proven to to be grossly undercounting Adverse Events.
"Anaphylaxis is a well known side effect and doctors are required to report it," Dr. Rose states. "It occurs right after the shot. You can’t miss it. It should always be reported."
"A study at Mass General Brigham (MGM) that assessed anaphylaxis in a clinical setting after the administration of COVID-19 vaccines published in JAMA on March 8, 2021, found 'severe reactions consistent with anaphylaxis occurred at a rate of 2.47 per 10,000' people fully vaccinated," she points out. "This rate is based on reactions occurring within 2 hours of vaccination, the mean time was 17 minutes after vaccination. This study used 'active' surveillance and tried not to miss any cases."
"When asked about this, both the CDC and FDA sidestepped answering the question," she continues. "Here’s the proof at the CDC (see page 1 which incorporates the CDC response to the original letter on pages 2 and 3). As noted in the letter, this implies that VAERS is underreporting anaphylaxis by 50X to 123X. The CDC chose not to respond to the letter."
Dr. Rose provided a safe estimate in her study. "We’ve vaccinated 97.5M people from the start thru March 2021 and there were 583 reports in VAERS who had an anaphylaxis reaction on their first dose. This suggests that the underreporting rate is 41X."
Reuters reached out to the FDA to rebut the claims made by Dr. Rose about the anaphylaxis reporting, as well as the sensational claims based on her analysis that the vaccines have led to an estimated 148,000 to 216,000 deaths.
"An FDA spokesperson told Reuters in an email that it 'strongly disagrees' with the analysis put forth in the report," Reuters said. "They added that the claim 150,000 people have died in the United States as a result of COVID-19 vaccines is not accurate and is based on data from VAERS that was not properly interpreted."
The spokesperson said: “Although under reporting is a limitation in VAERS, with regard to COVID-19 vaccine safety monitoring, there currently is not evidence to suggest it would underestimate the amount of COVID-19 vaccine-related deaths to such a large degree.”
Not exactly reassuring. Dr. Rose also made a comment that incidentally jibes with an exclusive report from Becker News published recently.
"All-cause mortality is the single most important thing to focus on and it’s not there," Dr. Rose commented in her VAERS study. "Today, most people focus on the relative risk reduction of the vaccines against infection, hospitalization death from COVID. They pay less attention to the absolute risk reduction from COVID. And they pay no attention at all to the absolute all-cause mortality benefit. The funny thing is that we should be paying attention to these in the opposite order that we listed them."
"All-cause mortality is key," she adds. "If there is no improvement in all-cause mortality, nothing else matters."
You can read her entire report and her reasoning below:
A recent investigation into all-cause excess mortality showed that there is no significant difference from 2020, despite the mass rollout of the 'vaccines.'
All-cause mortality is a more holistic snapshot than merely focusing on Covid excess mortality. This is because it helps us assess if people are dying from the impact of Covid response policies, such as increased suicide rates, missing vital health screenings, and other public health tradeoffs. It also helps us contextualize the overall effects of the 'vaccines.'
What we find from an examination of the evidence provided by the CDC itself is that the vaccines are not lowering excess mortality rates; particularly, the average percentages of excess mortality in each reporting period year-over-year.
The CDC's website shows the excess mortality from 2018 to present (but the expected mean is based on 6 years of data, the CDC notes). The excess mortality for each weekly reporting period can be seen below.
As you can see, from January 2021 to present, there was a peak at around the time of President Biden's inauguration on January 20, followed by a decline in the weekly excess mortality figures, then a second wave that came with a Delta variant spike.
While there is no option available to directly compare the year-over-year weekly rates as a percentage, you can download the raw data and sort the weekly reports to find these figures. The average weekly excess mortality rate, expressed as a percentage in 2020: 15.65% above the mean. In 2021, that figure has been 16.31% above the mean.
There is even more evidence that points to VAERS data providing Adverse Events data that are far below the actual experienced cases.
A recent Baris poll, conducted by Richard Baris (also known as the People's Pundit), one of the best pollsters in the country, points to the truly massive scale of the adverse events.
His latest poll showed that "serious adverse effects" from the Covid vaccines – described as events so serious they "prevent daily activity" – were reported to be 5.2% among all groups.
This result spans self-identified Democrat, Republican, and Independent voters. Independent voters had the highest reported serious adverse effect rate at 6.5%.
The extrapolated data projects out at a national scale to around 9.4 million "serious" adverse events, which dwarf the VAERS reports by 14 times over. But if you take all of the events together, a whopping 63% of Americans who take the vaccines have some kind of adverse event.
Since there are 194 million Americans who are reportedly "fully vaccinated," or nearly 60% of the population, there is no way to square the VAERS reports and the scale of AEs suggested by this polling data.
It's not just pollsters who are sounding the alarm on serious Covid vaccine events: Cardiologists are reporting a huge spike in heart inflammation cases to the American Heart Association (AHA).
A retired cardiac surgeon circulated a warning to the AHA that heart inflammation markers are drastically increasing in patients in conjunction with increasing mRNA Covid vaccination rates.
The warning to the AHA is clear: “Patients had a 1 in 4 risk for severe problems after the vaccines, compared to 1 in 9 before.”
The controversial memo, which is a call for further research, has drawn a backlash among outlets attempting to control the narrative. But it has more corroboration than the mainstream media lets on.
An NIH-hosted scientific publication explored the potential relationship between the mRNA 'vaccines' and heart inflammation reports in July 2021.
"As of 26 June 2021, a total of 322 million doses of vaccine were used, and thus far, 79 children aged 16 or 17 years, and 196 young adults aged 18–24 years have been confirmed by the CDC as having myocarditis/pericarditis following mRNA COVID-19 vaccination after analyzing data in the VAERS," the paper points out.
"The adjusted risk ratio for myocarditis and pericarditis events in children and young adults between 16 and 24 years of age has been determined to be 0.94 (95% confidence interval 0.59–1.52). Because of this, the US FDA added a warning about risk of myopericarditis and pericarditis to the fact sheet of mRNA COVID-19 vaccines."
Now, the FDA is admitting there is now major concern over another Pfizer product.