Wait, What? How Does This Abysmal, Shambolic Data Justify the Approval of the Pfizer Vaccine?
I reiterate our call: “slow down and get the science right"
- “…the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.”
- “…it is notable that evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off.”
- “But although this additional information was available to Pfizer in April, it was not published until the end of July.”
- “Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.”
- “So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months”
- “It is hard to imagine that the <10% of trial participants who remained blinded at six months (which presumably further dwindled after 13 March 2021) could constitute a reliable or valid sample to produce further findings”
- “…no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data”
On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”
But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”
The 20-page preprint matters because it represents the most detailed public account of the pivotal trial data Pfizer submittedin pursuit of the world’s first “full approval” of a coronavirus vaccine from the Food and Drug Administration. It deserves careful scrutiny.
The elephant named “waning immunity”
Since late last year, we’ve heard that Pfizer and Moderna’s vaccines are “95% effective” with even greater efficacy against severe disease (“100% effective,” Moderna said).
Whatever one thinks about the “95% effective” claims (my thoughts are here), even the most enthusiastic commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s advisory committee last December.
The concern, of course, was decreased efficacy over time. “Waning immunity” is a known problem for influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a vaccine taken early may ultimately provide no protection by the time “flu season” arrives some months later. If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine provide when a person is actually exposed to the virus? Unlike covid vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.
And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.
Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to all adults over 40. And starting 20 September 2021, the US plans to follow suit for all “fully vaccinated” adults eight months past their second dose.
Delta may not be responsible
Enter Pfizer’s preprint. As an RCT reporting “up to six months of follow-up,” it is notable that evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off.
“From its peak post-dose 2,” the study authors write, “observed VE [vaccine efficacy] declined.” From 96% to 90% (from two months to <4 months), then to 84% (95% CI 75 to 90) “from four months to the data cut-off,” which, by my calculation (see footnote at the end of the piece), was about one month later.
But although this additional information was available to Pfizer in April, it was not published until the end of July.
And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.
Waning efficacy has the potential to be far more than a minor inconvenience; it can dramatically change the risk-benefit calculus. And whatever its cause—intrinsic properties of the vaccine, the circulation of new variants, some combination of the two, or something else—the bottom line is that vaccines need to be effective.
Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.
The “six month” preprint based on the 7% of trial participants who remained blinded at six months
The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).
This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)
Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.
It is hard to imagine that the <10% of trial participants who remained blinded at six months (which presumably further dwindled after 13 March 2021) could constitute a reliable or valid sample to produce further findings. And the preprint does not report any demographic comparisons to justify future analyses.
With the US awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”
Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.
In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).
And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).
The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question.
Approval imminent without data transparency, or even an advisory committee meeting?
Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A “full approval” could remain a high bar.
But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,” but provides no data tables showing the frequency of these, or other, adverse events.)
It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”)
Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.
I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”
FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.
Peter Doshi, senior editor, The BMJ.
Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.
Provenance: commissioned; externally peer-reviewed.
Footnote: Calculations in this article are as follows. “About 1 month” past month 4 is based on the final row of Fig 2 in the preprint: 1030/12670*12 = 0.98 months (vaccine group) and 895/11802*12 = 0.91 months (placebo group). “53%” is based on Fig 2: (12670+11802)/(23040+23037). “4.4 months” is based on the average of 8412/22505*12 = 4.5 (vaccine) and 8124/22434*12 = 4.3 (placebo) in Fig 2.
Source: The BMJ
“Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year.”
I must be missing a gene or something!
On July 31,2021 the EU deaths were 20,525
On Aug 14,2021 the EU deaths were 21,766
In 14 days 1,241 people lost their lives to the vaxx.
That averages 89 deaths per day.
Note: As of Aug 13,2021 13,033 died in the USA. 9,024 from the now approved Pfizer kill shot. It appears the one kills the most wins the approval!
In the swine flu of the 1976 the vaccine was halted after 32 deaths.
Today with the covid an average of almost three times as many are dying each and every day!
Instead of halting the shots they are threatening your jobs,,, travel,,, selling and buying including in France the purchase of food if you don’t want to risk your life taking one of these murderous injections.
I have read many articles questioning the efficacy of this (not) vaccine. But they almost never mention the deaths and injuries.
Now most of these deaths are older people so I have to assume in the case of the vaxx,,, Grandma doesn’t matter.
BUT in the case of the face diaper, if you don’t wear one, you are killing grandma!
What Old people’s lives don’t matter?
I am so confused. Now the children are targets. Their experiencing a slew of different heart ailments and some are dying.
In Australia they rounded up 24,000 kids in a large stadium, (no parents allowed) for mass injections. They used to do the same when rounding up cattle for branding. Reports are three died but the nazis have yet to verify. No idea of how many other adverse events there were. If they follow past examples,,, they’ll lie.
The jabs don’t even prevent the alleged disease nor stop its transmission according to the manufacturers.
So besides killing off old people in nursing homes what is the reason for taking the damn thing?
And then the Fraudci Death Agency captured by the pharma drug lords approves the safe and effective jab. Again,,, what am I missing!
This is USDA Grade A lunacy.
Remember only 1 in 10 report a adverse event. Case of the Irish footballer who died from an illness even though he had the jab a few days before. How many more have died from “a short illness”? And why is media covering up the murders?
I have a very small Circle of friends and family…and yet Know of two family members who gave up on eating for a while quite shortly after having one of these injections…J&J for my Grandmother, and Pfizer for a much younger Sister in Law ( early 40’s) who just stopped eating, basically zombified both of them for a while.
Now my grandmother was pretty old…dead seven months after the injection at 99. She had a heart attack 2 months after ( the first) “not eating episode” subsided and “was on the mend”, then went to Hospital in a walker, 2 days later discharged not ambulatory. Went downhill with (episode #2) again not eating , ended up lasting another 2 weeks, this time COMPLETELY refusing food or water, and dying just last week.
Of course we know most of these Adverse reactions will NOT reach “Vears” for multiple reasons, maybe at most 10% get reported, that is the high estimate, I think the estimate in the U.K. is 5%, maybe Europe is a bit better, but I doubt the majority are reported even there…
Now we learn of the possibility of a Children born during these last ( almost) 2 years are way below average I.Q…..possibly 22 points lower, that is BAD news. SOMETHING is killing people ( along with medical neglegence, and plain murder.)
SOMETHING is lowering IQ ( messing with the brain in adults and Children)….parents at home have MORE interaction with children, not less, so the reasons they give are totally fabricated IMHO.
“, Nobel Prize winner Luc Montagnier expressed strong concerns about the coronavirus vaccine’s mid-term, long-term, and even generational consequences. Montagnier warned that “neurodegenerative illness” is a potential side effect of the coronavirus vaccine and said in no uncertain terms that he is “outraged” about the widespread vaccination of children….
Montagnier said in part:
…Prof. Montagnier is “outraged” that widespread vaccination of children could have horrific generational consequences.
He gives the example of the herbicide glyphosate, which can be passed on to future generations in a process known as “Transgenerational Epigenetic Inheritance.”
“Recent studies on glyphosate have shown that there are epigenetic effects,” Prof. Montagnier explained. “That means people who eat glyphosate in their diet pass on something that will affect future generations. Their children, their grandchildren, and great-grandchildren, they will suffer,” he continued….
Another concern Montagnier expresses is the possibility of side effects of vaccines that could be seen in “five to ten years” related to “neurodegenerative illness.”
Neurodegenerative disease is “an umbrella term for a range of conditions which primarily affect the neurons in the human brain” and is described as “incurable and debilitating conditions that result in progressive degeneration and/or death of nerve cells.”
Montagnier states that there “are sequences that resemble the prion sequences in the RNA of the coronavirus” and could therefore “disorder the natural proteins in the brain, modifying them to make prions.”
A research article titled “RNA editing alterations define manifestation of prion diseases” explains that “Prion diseases are fatal neurodegenerative disorders characterized by rapidly progressive dementia.”
The way I see it, if certain Viral Sequences of RNA can possibly cause harm…could it not be that the VIRUS ITSELF could cause damage in Utero ??( assuming it has the DNA we are told)
Now Ken, I have read your other posts, and I respect your opinion. NO I can not produce a purified SARS 2 Covid -19 virus for you, and it seems no one want to take the time to do so… BUT if there is ONE public figure who I would trust to be honest, it would be Dr. Luc.
It was never about “grandma”. It was about exercising control over recalcitrant white fellaheen, a new order which is now nearly complete. So pointing out the contradictions is totally useless.
Schleimacher, Dilthey, Gadamer etc all attributed misunderstanding to “hastiness and prejudice”
“busy busy numb–amerikans cannot feel themselves alive unless they feel themselves busy. amerika is a vast goo of meaningless stimulation”. Thomas de Zengodita
“speed obliterates the capacity to think”. Zygmunt Bauman
“amerikans cannot think except by means of slogans–they identify garbage as quality. the stupidity and ignorance of amerikans ha long been a topic of hilarity in Europe”. Paul Fussell
now amerikans so sexually repressed they protest for more sexual repression….100 prominent French females in a letter to Le Monde described the amerikan “me too” movement as “puritanism”
nothing has changed in USA since the puritans wrote that idle hands are the devils handmaiden
If Americans were so Stupid then why did the lend lease Jeeps work? Why Did both Germany and Russia use Ford and other USA made Trucks in WWII?
by Pips » 18 Nov 2008, 10:38
Here are just a few of the items of over all Lend Lease supplies from America and the UK to Russia.
Fighters – 9,438
Bombers – 3,771
Tanks – 6,196
Trucks – 363,080
Jeeps – 43,728
Explosives – 32,200 (tons)
Radio Stations – 35,089
Field telephones – 380,135
Radio Receivers – 5,899
Telephone Wires – 956,688 (miles)
Locomotives – 1,900
Railway Cars – 11,075
Canned Meats – 782,973 (tons)
Boots – 14,793,000 (pairs)
Belts – 2,57700
Copper – 339,599 (tons)
Aluminium – 261,311 (tons)
NB> trucks are broken down as 151,000 light trucks and 212,080 Studebaker army trucks.
Sources: North American Supply by H.D.Hall; and Feeding the Bear:American Aid to Soviet Russia 1941-1945 by H. van Tuyll.”
I appreciate the U.S.A. is sanctioning out the wazoo anything remotely Russian, but please don’t think that everybody in the USA hates Russia, only about 1/2 the country does ( at most). I would guess 1/4 of the USA ( esp. former military) respect Russia as an worthy and intelligent foe, and the last 1/4 of the population would take Putin as the Messiah.
Germany was brainwashed into WWII, and they led the world in Science at the time, so too it can happen in ANY country.
Don’t bother, Yurin Is our local retard.
He is also a Zionist and a homosexual.
Not that that matters of course.
racist amerikan rat driver expert homosexual…”only in amerika is the father vestigial: the amerikan mind and conscience is feminine”. Geoffrey Gorer
“nothing can thrive in amerika unless inflated by hyperbole and gilded with a fine coat of fraud. amerikans cannot think except by means of slogans—they identify garbage as quality. the stupidity and ignorance of amerikans has long been a topic of hilarity in Europe”. Paul Fussell
atheist rat driver proof….”stupidity is a virtue in amerika”. Charles Pierce (2010)
even the anti-communist Arthur Koestler compared you to 5th century Romans: “a similarly contactless society populated by automatons…a similarly soulless politically corrupt everybody for themselves society”. LOL now run to mommy you racist feminized uneducated hillbilly robot….
rat driver expert retard–uneducated hillbilly janitor, racist, Russophobe, homophobe—insecure feminized by “tyranny of the school mar’m”. Boorstin/Hofstadter, etc….LOL
69% of your university grads not English proficient—US dept of Ed…and an idiot like rat driver believes she can think
“the monolingual inevitably confuses style with content”. George Simmel
a nation of bad style no content…”the banality of amerika–the radical absence of culture”. no run to your LGBT black live matter ghetto to learn about “culture”
wikipedia lies—less than 15% lend lease provided to USSR…I care less what your CIA website claims
A) It’s not from Wikipedia.
B) 15% of WHAT? the total wartime production? please define what you are trying to say… Even if it was only 15% ( disputed) the USA provided very crucial items.
“8,000 planes” sent with lend lease..
( a lesser Number that posted before, but still huge)…even Tass ( which I read quite a lot of actually) admits Lend Lease was a big help…
Here is another TASS article on lend lease that claims many more planes:
“To Murmansk and Arkhangelsk were delivered more than 22,000 planes, more than 13,000 tanks, 13,000 guns, 639 ships and other vital cargo, including food – all that worth more than $2 billion. The cargo satisfied about 12% of the front’s and rear’s demands.”
So 13,000 tanks and 22,000 planes were only 12% of the equipment, hardly, the Soviet Union had a total of planes and tanks….now the food and rifles were likely only 12% of the needs…BUT The most important items to fight the Nazis ( Planes and Tanks) that were most in need were in MUCH lager percentages of the Soviet arsenal…
“Could the Red Army have won the war alone?
This kill-to-loss ratio destroys another recent myth, which has recently come again into fashion, which refers to the situation on the Eastern Front. It is said that the Russians could have won the Second World War without any support from the US or Commonwealth forces, above all because of their large quantity of produced T-34 tanks.
This assertion is untenable, as is shown by the loss ratio – and even before the increased production in Germany had been taken into account, because of the absence of the Allied bombing war. At the same time, the increasing German air superiority on the Eastern Front from 1943 on would have acted, while the Red Army would have been deprived of half of its motorized transport, which consisted of Lend-Lease vehicles.
The 9,000 to 10,000 88mm Flak guns, which would not have been necessary to defend Germany against Allied air raids, could have been used as an effective anti-tank force on the Eastern Front.
In addition, e.g. tor the approximately 1,000 then non-necessary German U-boats, other war materials – such as tanks – could have been produced.”
At the Front lines in 1945 the Soviets had maximum 15,000 tanks, to say the number from the lend lease ( total over the WWII Years of 13,000 tanks) is only 12-15% is simply not correct:
“In mid-1943 it again had about 8,000 tanks at the front and in 1945 at least 15,000.”
C) Please note You ( Yuri) started the name calling, don’t expect others to be as nice as me…personally I could care less…but it’s just silly to call a whole nation “stupid”.
recent studies find that 80% amerikans express racist attitudes about Chinese and Russians…my Austrian friend lives in USA—he reports whenever he disagrees with amerikans he is accused of being Russian
And Russians never ever have racism? Are you serious? I knew quite few Russian nationals overseas, and they were just as racist as Americans IMHO.
I cant help what the US government does to blame Russia /China for everything ( it itself a from of racism), but sitting here on an Amrican run website calling the USA names is not going to help, trust me.
nearly none of the trash provided USSR functioned nor was used as all Soviet historians document…even Hofstadter described amerikan academics as “technicians that serve power with a thin understanding of everything”. “amerikan academia is far more effectively censored than was Soviet academia ” G Derlugian (2019)
“censorship reflects a society that has no confidence in it self”. Potter Stewart
after examine media and school curriculum in USSR Geofrey Gorer described censorship in US media schools as “ludicrous”
Censorship exists everywhere…the best slave thinks he is free. 🙂
Right now the USA is undergoing a “cultural revolution” from the top down, not unlike Mao Zedong’s China…In Russia the KGB was in control, in the USA the CIA, what has changed??? NOTHING.
“amerikans, especially males are troubled with a basic insecurity inadequately disguised by their boasting and bragging…amerikans are insatiable for reassurance, signs of friendship and love”. Geoffrey Gorer
“the least reproach offends amerikans–the slightest sharp sting of truth turns amerikans fierce”. Tocqueville
nothing changes in USA
I doubt these people you quote really lived in the USA of 30 years ago…yes its worse now a lot has been done to lower standards of education and less critical thinking…but just for fun let’s lighten the load with some James Brown:
Phyzer and the FDA just reinvented the phrase – Weapons of Mass Destruction. Unfortunately the UN, the Hague, the ICC , the World Court are all in on the Genocide.
Zionist mafia is making billions
While killing 50% of the population.
Whores are more trustworthy than the CDC or FDA.