1. More Americans died in 2021 with the vaccine available than in 2020—with the vaccine available and the majority of Americans taking Pfizer's.
2. By the end of 2021, in some places, a greater percentage of the vaccinated were dying from COVID-19 than the unvaccinated. As per the filing, the Pfizer shot was plainly not "95% effective." The suit gets into the why and how shortly.
So, how did the shot achieve such widespread adoption yet fall short of the stated goal of ending the pandemic? Pfizer lied. They only told the public it was 95% effective based on the relative risk reduction for vaccinated individuals in their not yet completed study. The FDA agrees that relative risk isn't the proper way to present risk, stating: “...when information is presented in a relative risk format, the risk reduction seems large and treatments are viewed more favorably than when the same information is presented” using more accurate metrics."
Their claim made the shot seem highly effective, but the truth differed. When Pfizer began making those claims, they possessed, on average, only about 2 months of clinical trial data from which to compare vaccinated and unvaccinated individuals. We are going to break this down and explain the difference between different types of assessments here momentarily.
Of 17,000 placebo recipients, only 162 acquired COVID during the two-month period. Based on those numbers, vaccination status had a negligible impact on whether a trial participant contracted COVID. As a matter of fact, the risk of acquiring COVID was so small in the short initial window that it showed the shot only fractionally improved a person's risk of infection. A recipient's "absolute risk reduction" (the FDA's preferred method for efficacy) showed that the shot was merely .85% effective. They gamed the numbers.
As per the filing, once Pfizer seeded the market with the 95% efficacy claim, it continued to deceive the public in numerous ways.
1. Duration of Protection: When it first granted an EUA, the FDA recognized that it wasn't impossible to know how effective the shot would remain beyond two months. By early 2021, Pfizer deliberately created the impression that the shot had durable and sustained protections, even withholding highly relevant data from the public that demonstrated rapidly waning efficacy.
2. Transmission: The FDA had warned Pfizer that it needed more info to determine whether the shot protected against transmission between individuals, but Pfizer instead engaged in a "fear-mongering campaign" exploiting the public fear over the virus by insinuating that the shot was necessary to protect their loved ones from getting COVID.
3. Variant Protection: Pfizer knowingly made false and unsupported claims about the shot's performance against variants, including the Delta variant. The shot performed remarkably poorly against the Delta variant, and Pfizer's data confirmed that. Nonetheless, they told the public that its shot was "very, very effective against Delta."
As per the suit, as Pfizer bragged about the vaccine's success, many pieces of information came to prove that the shot failed to live up to the hype. For example, shortly after Delta's emergence in Israel (a country Pfizer used as a "canary in a coal mine"), the relative risk reduction dropped precipitously, from 64% in June, to just 39% one month later.
4. Negative Efficacy: Certain jurisdictions reported negative vaccine efficacy in late 2021 and early 2022, meaning that a greater percentage of vaccinated people contracted and died from COVID than the unvaccinated.
Additionally, the number of people infected with COVID-19 increased over time. In the UK, infection rates were 7% from 4/26/20 through 12/7/20 (before the approval and distribution) but were 24.2% between 5/18/21 and 12/13/21 and 33.6% from 12/14/21-2/21/21...
5. Pfizer Tried to Silence the Former FDA Director: When it became apparent that the shot was failing and its profits were under threat, Pfizer set out on an intimidation campaign, going so far as to censor the critics (I know all too well, and so do many of you.)
They labeled anyone who spread facts about the above as "criminals," accused them of spreading "misinformation," and coerced social media platforms to silence prominent truth-tellers. They even went so far as to request that social media silence the former FDA director because his comments could "drive news coverage" critical of the vaccine.
Pfizer seems to be hiding behind comments from the FDA and its EUA approval to shield them from scrutiny on the facts in the lawsuit.
"In summary, Pfizer intentionally misrepresented the efficacy of its COVID-19 vaccine and censored persons who threatened to disseminate the truth in order to facilitate fast adoption of the product and expand its commercial opportunity. In light of the multi-billion dollar bet that Pfizer made on the vaccine and its need to quickly establish the product as the marketing leader, was heavily incentivized to, and in fact did, make misrepresentations intended to confuse and mislead the public in order to achieve widespread adoption of its vaccine. This suit seeks to hold Pfizer responsible for its scheme of serial misrepresentations and deceptive trade practices.."
The petition spends several pages reviewing the requirements for EUA approval vs. full FDA approval and a few pages talking about the rules governing deceptive marketing tactics. This lays the background for how Texas alleges Pfizer abused these rules. To detail all of this would be time-consuming and repetitive. If you would like to read this for yourself, the relevant pages are 7-12.
However, I would like to detail the guidance from the FDA on how to accurately convey risk and efficacy because it is important to understand the rest of the suit. Let's define some terms/concepts.
1. Absolute Risk: This is the likelihood that a person will experience a particular treatment outcome. Someone may have a 1 in 10k chance of getting a certain cancer. (.01% baseline risk) Absolute risk reduction measures the reduction in the baseline risk if the person engages in some course of treatment. For example, someone may take an experimental drug intended to lower the risk of that certain cancer so that the baseline risk drops from 1 in 10K to 1 in 20K (.005% post-treatment risk). Absolute risk reduction is calculated by the difference between those two values.
2. Relative Risk: This is the likelihood of an individual experiencing a certain treatment outcome by comparing two scenarios. For example: The person above has a 1 in 10K chance of developing a certain cancer without treatment and a 1 in 20K chance with treatment. Therefore, her relative risk of that cancer if she takes the treatment is half that of what it would be if she didn't.
3. Number Needed to Treat (NNT): This reflects the number of patients that would have to be treated by a particular intervention to be able to prevent one additional negative outcome. A drug with an NNT of 10 means that 10 people require treatment with that drug to avoid one negative outcome the drug is intended to prevent.
As you can see, these are three very different ways of representing a drug's benefit/efficacy/risk. Keep these handy. You are about to need them.
The FDA doesn't want pharmaceutical companies to use just relative risk because it is misleading. They want companies to use absolute risks or couple absolute risks with relative ones. Otherwise, they risk influencing patients based on their representations of the data... Tsk. Tsk.
This is a chart that demonstrates the same data across different methods of risk analysis—you can clearly see why relative risk isn't the standard.
Pfizer used only the relative risk assessment to declare that the shot was 95% effective. We will demonstrate how in the posts to follow...
On 11/20/20, Pfizer submitted an EUA request for its vaccine designated BNT162b2. As a part of that application, they submitted safety and efficacy data from an ongoing Phase 3 trial—not a completed clinical trial.
Phase I trials started on 4/23/20 in a limited number of people. On 7/27/20, after those results, they began enrolling subjects in a joint Phase II/III trial. They were randomized into two equal groups and received 2 doses of the shot or placebo 21 days apart. For the purposes of the EUA, they monitored those subjects' status and whether they got COVID until 11/14/20.
The Phase II/III study investigated two efficacy endpoints (the metrics used to determine whether the shot was successful.) The first endpoint measured COVID incidence per 10,000 person-years of follow-up in people without evidence of past infection, before and after vaccine, with confirmed cases in people 7 days after dose 2.
The second endpoint sought to measure how often COVID-19 arose in patients 7 days after the second dose, including in those who may have been infected before.
The results submitted to the FDA comprised 43,448 participants. 21,720 of them received the Pfizer shot, and 21,728 got a placebo. They had hastily added 14,000 additional participants. They said they had followed the trial participants for a median of two months after participation. Still, in November 2020, the FDA found that only 43.9% of the participants completed at least two months of follow-up after receiving the 2nd dose.
This is how Pfizer made the 95% effective claim: As of 11/14/20, 8 out of 17,411 participants (.04%) who received the shot and didn't have COVID prior experienced a defined case during the trial. In the placebo group, as of 11/14/20, 162 out of 17,511 participants (.9%) who didn't have evidence of prior infection experienced a defined case during the trial. The relative risk reduction between the placebo group and the treatment group? Was 95%....
HOWEVER—the ABSOLUTE risk reduction was only .85%. And the NNT was 119. One hundred nineteen people needed to be vaccinated to prevent one single defined COVID case.
Something many of us said is also mentioned here. They engineered the trial so that only COVID cases that occurred 7 days after shot two. 409 cases in the vaccination group happened after the first shot but before the 7-day mark after shot two. In the placebo group, that number was only 287. More people got COVID between doses in the vaccinated group vs. the unvaccinated group...
As per the petition, the FDA told everyone in its fact sheet for patients and providers that Pfizer's results didn't support what Pfizer was representing to the public.
Several pages go on to explain how Pfizer needed to remain competitive in a highly crowded field—the US had entered into contracts with other manufacturers, and Pfizer was also relying on the EUA from the US to establish its credibility with the shot across the world.
And the PR campaign began earnestly using the relative risk 95% effectiveness claim... The press release to pump the shot mentioned the effectiveness several times. Pfizer's own trial results showed that the vaccine would reduce the incidence of the non-vaccinated contracting COVID-19 by 1%.
Bourla went on a publicity tour touting what the petition states are inaccurate claims. Bourla stated that the trial’s efficacy data “provides the initial evidence of our vaccine’s ability to prevent COVID-19.” And “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”
And yet another press release touted the 95% efficacy without letting the rest of the data out—including absolute risk and NNT. They obfuscated and lied to get you to take it, so they could make money.
Pfizer knew the media would run with its claims and become a marketing arm for the company, and boy did they...
“I [will] repeat once more. The decision not to vaccinate will not affect only your health or your life,” but also “[u]nfortunately it will affect the lives of others, and likely the lives of the people you love the most.” Bourla also used intimidation tactics to lie on national television about the vaccine's efficacy regarding transmissibility when they knew what they were saying was false...
(This is evil.....)
“[i]t is very important to enable [adolescents] to get back to everyday school life and to meet friends and family while protecting them and their loved ones.” He also lied when he was trying to get your kids and adolescents to take the shot, using statements about transmission when their trial didn't evaluate transmission!!!!
He did the same thing all over the media with the waning of efficacy... They even withheld data contrary to their public claims.
Continuing Pfizer’s deception campaign—Bourla represented that Pfizer had new data addressing the “duration of the immunity” and that the vaccine provided “extremely, extremely high protection” against COVID-19 infection. HOWEVER, Pfizer knew by around mid-March 2021 that vaccine efficacy quickly deteriorated. He withheld that data from the public as he went on television claiming the opposite.
He also went around broadcasting that the shot was effective against all variants, at one point even claiming it was 100% effective against the South African variant—even though it was never tested for efficacy against variants.
Pfizer lied. People died. :/
As Pfizer was on its media tour touting the vaccine's efficacy and its longevity of protection, it was submitting its own data to the FDA for formal approval of "Comirnaty." The problem? NONE of the data used to support a full FDA approval matched what it was saying publicly. None of the data provided supported the efficacy of the shot against the Delta variant.
The data also had an issue. People in the trial were given the opportunity to "unblind" themselves. They wanted to get the shot if they had the placebo. This completely destroys the trial data. Almost everyone who got the placebo unblinded and took the shot... This is unbelievable.
The FDA identified serious risks for myocarditis and pericarditis following administration of Pfizer's vaccine..." 38 people died during the trial. 27 of them were in the vaccinated group. Many of them were a result of "cardiac conditions." The FDA said that it was "unlikely" the vaccine contributed to any deaths, but Pfizer's vaccine didn't prevent anyone from dying on the whole, as they claimed. The trial produced NO EVIDENCE that the vaccine prevented death, even if there was evidence it temporarily prevented some COVID cases. (Would you buy anything from the FDA???)
And more transmissibility data made its way out. Remember that gathering in MA? Turns out that the vaccine caused more COVID among the vaccinated.
Pfizer declared that they were using Israel as a "laboratory" and could count on it as the gold standard for data in terms of efficacy, etc.
1. By January 2021, the relative risk reduction in preventing infection and symptomatic disease fell to just 64%. 60% of the severe COVID in Israel in July and August of 2021 occurred in vaccinated people. Similar results happened here. You would never know it if you peered into the media, government, institutions, etc. We were all being accused of killing Grandma for remaining unvaccinated. Joe Biden was calling us super spreaders.
The shot was completely ineffective against Delta. It also didn't prevent ANY DEATHS. As a matter of fact, there were 750 deaths among people vaccinated and only 331 in the unvaccinated population here in the states.
Scotland also gives us some really revealing data. In the last week of 2021, there were appx 1k COVID cases for every 100K unvaccinated people. But, there were 2,550 cases for every 100K VACCINATED persons... The ratio of "boosted" persons who got COVID-19 was also higher than among the unvaccinated. Remember, folks, this is a "pandemic of the unvaccinated..."
Data doesn't lie when it comes to excess deaths. In the unvaccinated in the last week of 2021, the age-standardized mortality rate was 1.69 for every 100K people. In the vaccinated? It was three times higher... 6.55 out of every 100k.
Pfizer was denied FDA approval for its booster. It resubmitted the same data for an EUA, as the standard is less, and they still asked for more data on efficacy during the Delta wave. Pfizer went back and tried using an "antibodies only" approach to get the approval. I.e., If your body had produced antibodies, the shot was effective. However, that wasn't helpful because at the same time as Pfizer was trying to use that metric to show the shot worked, people/politicians/CDC, etc., all over were saying that antibodies weren't an accurate measure of immunity. (Remember the natural immunity nonsense?) The White House pushed the FDA to approve, causing the resignation of top vaccine regulators. Because the data didn't support the approval.
The rest of the lawsuit demonstrates ways that Scott Gottlieb worked on Pfizer's behalf to silence critics on social media, including Alex Berenson and former FDA Director Brett Giroir. Also, millions of other people like you and I were branded as criminals for accurately discussing the vaccine.
As a result of Pfizer's misconduct, 3.5 million people in TX were vaccinated by the end of October 2021. As of 11/10 this year, Texans have been administered almost 30 MILLION Pfizer doses. Pfizer's lies directly impacted the public's ability to make these decisions for themselves.
The lies were even more harmful because of the safety concerns, including myocarditis and pericarditis. If people had known about this (and other) safety concerns, many of them would have foregone the shots altogether.
Here are the counts TX is suing for:
Count I: Misrepresentations Concerning Relative Risk Reduction
Count II: Misrepresentations Concerning Durability of Protection.
Count III: Misrepresentations Concerning Transmission
Count IV: Misrepresentations Concerning Protection Against Variants.
Count V: Scheme to Conceal Vaccine Underperformance
The vaccine rollout is a wide-ranging conspiracy across the whole of government and the private sector. This lawsuit uncovers but a small fraction of what Pfizer is responsible for. It is a WONDERFUL first step. There are brave people—doctors, individuals, service members, moms, dads, grandparents, and organizations suing all across the country because of the havoc these vaccines caused. No, they didn't "save lives." This lawsuit proves that at a basic level.
I will be following this lawsuit in detail as it progresses through the court in TX. If you appreciate the work I do, we rely SOLELY on your kindness to continue. Please consider supporting us by visiting this link: https://UncoverDC.com/support.
It means more than you know. Share this thread with your friends, and thank @KenPaxtonTX and his team. This is a great first step.
